KCE REPORT 332C

SHORT REPORT
GUIDELINE ON THE PRUDENT PRESCRIPTION OF
ANTIBIOTICS IN THE DENTAL OFFICE

2020 www.kce.fgov.be
KCE REPORT 332C
GOOD CLINICAL PRACTICE

SHORT REPORT
GUIDELINE ON THE PRUDENT PRESCRIPTION OF
ANTIBIOTICS IN THE DENTAL OFFICE

ROOS LEROY, JOLYCE BOURGEOIS, LEEN VERLEYE, DOMINIQUE DECLERCK, PIETER DEPUYDT, ANOUK ELOOT, JOANA C CARVALHO, WIM
TEUGHELS, RITA CAUWELS, JULIAN LEPRINCE, SELENA TOMA, KATLEEN MICHIELS, SAM ARYANPOUR, ASTRID VANDEN ABBEELE, MIEKE DE
BRUYNE

2020 www.kce.fgov.be
We dedicate this guideline to our late colleague Hans Van Brabandt, a passionate

advocate of evidence-based medicine.

His scientific integrity and rigor will continue to guide our work;

We will always remember his joie de vivre.

KCE Report 332C Prudent prescription of antibiotics in the dental office 1

■ SHORT REPORT
TABLE OF CONTENTS ■ SHORT REPORT .................................................................................................................................. 1

1. INTRODUCTION ................................................................................................................................... 5

1.1. BACKGROUND ..................................................................................................................................... 5

1.1.1. Why a guideline on the prudent use of antibiotics in the dental office is needed ................... 5

1.1.2. Current use of antibiotics prescribed by dentists .................................................................... 5

1.2. SCOPE .................................................................................................................................................. 5

1.3. REMIT OF THE GUIDELINE................................................................................................................. 6

1.3.1. Overall objectives .................................................................................................................... 6

1.3.2. Population for which the guideline is meant............................................................................ 6

1.3.3. Target users of the guideline................................................................................................... 6

2. METHODOLOGY .................................................................................................................................. 7

2.1. THE GUIDELINE DEVELOPMENT GROUP ........................................................................................ 7

2.2. MARKING OUT THE SCOPE OF THE GUIDELINE ............................................................................ 7

2.3. SYSTEMATIC REVIEW OF THE LITERATURE................................................................................... 8

2.4. QUALITY ASSESSMENT...................................................................................................................... 8

2.5. FORMULATION OF RECOMMENDATIONS........................................................................................ 8

2.6. EXTERNAL REVIEW ............................................................................................................................ 9

2.7. FINAL VALIDATION ............................................................................................................................ 10

3. CLINICAL RECOMMENDATIONS ..................................................................................................... 10

3.1. SYMPTOMATIC IRREVERSIBLE PULPITIS IN THE PRIMARY DENTITION................................... 10

3.2. ODONTOGENIC ABSCESS IN THE PRIMARY DENTITION ............................................................ 11

3.3. SYMPTOMATIC IRREVERSIBLE PULPITIS IN THE PERMANENT DENTITION............................. 11

2 Prudent prescription of antibiotics in the dental office KCE Report 332C

3.4. SYMPTOMATIC APICAL PERIODONTITIS AND ACUTE APICAL ABSCESS IN THE PERMANENT

DENTITION ......................................................................................................................................... 12

3.5. REPLANTATION OF AVULSED PERMANENT TEETH .................................................................... 13

3.6. NON-SURGICAL TREATMENT OF AGGRESSIVE PERIODONTITIS.............................................. 13

3.7. PERIODONTAL ABSCESS IN THE PERMANENT DENTITION........................................................ 14

3.8. DENTAL IMPLANT PLACEMENT....................................................................................................... 14

3.9. EXTRACTION OF PERMANENT TEETH........................................................................................... 15

3.10. ANTIBIOTIC PROPHYLAXIS IN PATIENTS AT (HIGH) RISK OF INFECTIVE ENDOCARDITIS

UNDERGOING DENTAL PROCEDURES .......................................................................................... 15

3.11. ANTIBIOTIC PROPHYLAXIS IN PATIENTS WITH ORTHOPAEDIC JOINT IMPLANTS

UNDERGOING DENTAL PROCEDURES .......................................................................................... 16

4. ONGOING TRIALS AND RESEARCH RECOMMENDATIONS ........................................................ 16

5. DISSEMINATION, IMPLEMENTATION AND UPDATE OF THE GUIDELINE.................................. 17

5.1. DISSEMINATION & IMPLEMENTATION............................................................................................ 17

5.2. GUIDELINE UPDATE.......................................................................................................................... 17

■ POLICY RECOMMENDATIONS ........................................................................................................ 18

■ REFERENCE LIST.............................................................................................................................. 19

KCE Report 332C Prudent prescription of antibiotics in the dental office 3

LIST OF ABBREVIATION DEFINITION

ABBREVIATIONS AGREE Appraisal of Guidelines Research and Evaluation

AMSTAR A MeaSurement Tool to Assess systematic Reviews

ATC Anatomical Therapeutic Chemical

BAPCOC Belgian Antibiotic Policy Coordination Committee

BAET Belgian Association for Endodontology and Traumatology

BAPD Belgian Academy of Paediatric Dentistry (‘Belgische Academie voor

Kindertandheelkunde’/’L’Académie Belge de Dentisterie Pédiatrique (BAPD)’)

BCFI – CBIP Belgian Centre for Pharmacotherapeutic Information (‘Belgisch Centrum voor

Farmacotherapeutische Informatie’/ ‘Centre Belge d’Information

Pharmacothérapeutique’)

BVIKM – SBIMC Belgian society for infectiology and clinical microbiology (‘Belgische Vereniging voor

Infectiologie en Klinische Microbiologie’/’La Société Belge d''Infectiologie et de

Microbiologie Clinique’)

BVP Belgian Society of Periodontology (‘Belgische Vereniging voor Parodontologie’/

‘Société Belge de Parodontologie’)

CEBAM Belgian Centre for Evidence-Based Medicine (EBM)

CSD Professional association of dental practitioners (‘Chambre Syndicale Dentaire’)

ESC European Society of Cardiology

FAGG – AFMPS Federal Agency for Medicines and Health Products (‘Federaal Agentschap voor

Geneesmiddelen en Gezondheidsproducten’/’Agence Fédérale des Médicaments et

Produits de Santé’)

GDG Guideline Development Group

GRADE Grading of Recommendations, Assessment, Development and Evaluations

IE Infective endocarditis

KBVSMFH - SRBSCMF Scientific association of oral maxillofacial surgeons (’Koninklijke Belgische

Vereniging voor Stomatologie en Maxillo-Faciale Heelkunde’/‘Société Royale Belge

de Stomatologie et de Chirurgie Maxillo-Faciale’)

4 Prudent prescription of antibiotics in the dental office KCE Report 332C

KCE Belgian Health Care Knowledge Centre

MA Meta-analysis
PICO Population – Intervention – Comparator – Outcome
p.o. Per os (oral intake)
RCT Randomized controlled trial
RIZIV – INAMI National Institute for Health and Disability Insurance (‘Rijksinstituut voor Ziekte- en
Invaliditeitsverzekering’/’Institut National d’Assurance Maladie-Invalidité’)
ROBINS-I Risk of bias in non-randomized studies of interventions
SMD Professional association of dental practitioners (‘Société de Médecine Dentaire’)
SR Systematic Review
VBS-MKA – GBS-OMF Professional association of oral maxillofacial surgeons (‘Belgische
beroepsvereniging van de geneesheren-specialisten in de Stomatologie, Mond-,
Kaak- en Aangezichtschirurgie’/’Union professionnelle des médecins belges
spécialistes en stomatologie et chirurgie orale et maxillo-faciale’)
VBT Professional association of dental practitioners (‘Vlaamse Beroepsvereniging
Tandartsen’)
VVT Professional association of dental practitioners (‘Verbond der Vlaamse Tandartsen’)
VWVT Scientific association of dental practitioners (‘Vlaamse Wetenschappelijke
Vereniging voor Tandheelkunde’)
KCE Report 332C Prudent prescription of antibiotics in the dental office 5

1.1.2. Current use of antibiotics prescribed by dentists

1. INTRODUCTION A retrospective analysis of reimbursement data, provided by the National
Institute for Health and Disability Insurance (RIZIV – INAMI), revealed that
1.1. Background in 2016 5.8% of the total antibacterial use in the Belgian ambulatory
setting was prescribed by dentists.6 The relative ‘contribution’ to the total
1.1.1. Why a guideline on the prudent use of antibiotics in the antibiotic use in ambulatory care was especially high for amoxicillin (10.5%
dental office is needed of all amoxicillin used in Belgian ambulatory care was prescribed by
dentists), amoxicillin with an enzyme inhibitor (e.g. amoxicillin with clavulanic
Since the 1940s, when penicillin was made available for medical use, acid; 8.4%), clindamycin (20.1%) and metronidazole b (11.6%). In contrast,
antibiotics have made major contributions to public health.1 However, the the relative contribution of penicillin V was very low (0.3%). The ratio
use of antimicrobials can result in antimicrobial resistance, undermining
amoxicillin to amoxicillin in combination with clavulanic acid was 1.273.6
many of these advances. It is important to realise that the risk of
antimicrobial resistance increases if antimicrobials are used in a non-
prudent way, e.g. unnecessarily prescribed/used, at sub-therapeutic doses, 1.2. Scope
suboptimal spectrum, for inappropriate periods of time, or when they are The focus of the present guideline is limited to systemic antibiotics which
used against non-susceptible microorganisms.2, 3 Therefore, the prudent are administered per os; the rationale being that Belgian dentists are not
use a of antimicrobials is one of the main axes in tackling antimicrobial qualified to deliver drugs intravenously. In addition, locally delivered
resistance. Prudent use of antimicrobials should lead to more rational and antimicrobials (e.g. in gels, root canal sealers, fibres, controlled-release
targeted use, thereby maximising the therapeutic effect and minimising the products or ointments) were not considered, neither were antimicrobial
development of antimicrobial resistance.2 molecules used with non-antimicrobial purposes (e.g. low-dose
The prudent prescription of antibiotics starts with evidence-based doxycycline). Thus, in this guideline ‘antibiotic(s)’ should be read as
guidelines, which clearly outline for each indication whether antibiotics are ‘systemic antibiotic(s) which are administered per os’; antimicrobial
indicated, and if so, which antibacterial agent, dose and duration are photodynamic therapy c was also considered out of scope for the present
preferred. As was also mentioned in KCE Report 311, anno 2020 there is guideline.
still no guideline on the prudent use of antibiotics for dentists, and for certain
indications the available guidance misses consistency.5

a Several synonyms have been used for ‘prudent’ use of antibiotics, e.g. b Metronidazole is stricto senso an antiprotozoal (Anatomical Therapeutic
‘appropriate’, ‘rational’, ‘judicious’ and ‘responsible’. In the European Union, Chemical (ATC) code P01AB), yet it is also active against anaerobic bacteria.
the term ‘prudent use’ is preferred, defined by the European Commission as
a use which benefits the patient while at the same time minimises the
c Antimicrobial photodynamic therapy or photodynamic inactivation has been
probability of adverse effects and the emergence or spread of antimicrobial suggested to eradicate pathogenic microorganisms such as Gram-positive
resistance.4 ‘Prudent’ is thus used with the same purpose as rational, and Gram-negative bacteria, yeasts and fungi. The principles of
adequate or correct use of antibiotics. photodynamic therapy involve the use of a non-toxic light-sensitive dye
called a ‘photosensitizer’ combined with harmless visible light (low energy)
6 Prudent prescription of antibiotics in the dental office KCE Report 332C

The different indications under study in this guideline are listed in section 1.3.3. Target users of the guideline
2.2.
This guideline is primarily developed for dentists. In the second place, this
guideline is also intended for general practitioners who are confronted with
1.3. Remit of the guideline patients suffering from infections in the oral cavity. The literature review on
which this guideline is based, provides the evidence that in case of infection,
1.3.1. Overall objectives source control (through dental treatment) should be the first choice of
This clinical practice guideline provides evidence-based recommendations treatment and that adjunctive antibiotics are rarely indicated. In case a
for the prudent use of antibiotics in 12 situations frequently encountered in patient consult his GP with complaints which may indicate an acute pulpitis,
the dental office. Clinicians are encouraged to interpret these peri-apical periodontitis, an acute peri-apical or periodontal abscess without
recommendations in the context of the individual patient situation, values systemic involvement, the GP should refer this patient to a dentist so that
and preferences. The main objective of the present guideline is to reduce the correct diagnosis can be made and the necessary dental treatment
the non-prudent prescription of antibiotics by dentists (and to a lesser can be started. d If indicated, pain medication can be initiated.
extent by general practitioners), and ultimately to reduce antibacterial In addition, the authors hope that the content of this guideline will be
resistance. Another objective of this guideline is to reduce the variability in incorporated in the academic teaching base on the prudent prescription and
clinical practice and to improve the communication between care providers use of antibiotics in the Belgian dental schools, as well as in the continuous
and patients (e.g. to explain why antibiotics are not indicated in certain education programmes for dental professionals and general practitioners.
situations).
Last, this guideline may be of interest to patients and their families, and to
1.3.2. Population for which the guideline is meant policy makers.

The target population of this guideline are medically fit patients who
present in the dental office with one of the indications specified in section
2.2. In case a dentist has doubts whether the patient in front of him can be
considered medically fit and can be treated as is indicated in the guideline,
he is advised to contact the physician of the patient and discuss the optimal
treatment pathway.

of the appropriate wavelength to match the absorption spectrum of the (Brussels) or https://www.dentistedegarde.be/ (Wallonia). Currently, there is
photosensitizer. This procedure stimulates the dye to form free radicals of a shortage of dentists in certain parts of Belgium, which may jeopardise the
singlet oxygen that will act as toxic agents to the bacteria/cell.7 continuity of care. However, solving this problem is beyond the scope of this
guideline.
d During weekends and public holidays, the general dentist's on-call service
can be reached at 0903 39969 (Flanders), http://www.gardedentaire.be/
KCE Report 332C Prudent prescription of antibiotics in the dental office 7

2. METHODOLOGY ‘Symptomatic irreversible pulpitis in primary teeth’ was added, leading to a

final list of 12 indications:

2.1. The Guideline Development Group 1. Symptomatic irreversible pulpitis in primary teeth

This guideline was developed by KCE researchers, in close collaboration 2. Odontogenic abscess in primary teeth
with a multidisciplinary group of practicing clinicians and academic experts 3. Symptomatic irreversible pulpitis in permanent teeth
teaching in the Belgian dental schools (see list of authors). For the
discussion of the indications ‘Antibiotic prophylaxis in patients at (high) risk 4. Symptomatic apical periodontitis in permanent teeth
of infective endocarditis undergoing dental procedures’ and ‘Antibiotic 5. Symptomatic acute apical abscess in permanent teeth
prophylaxis in patients with orthopaedic joint implants undergoing dental
procedures’ the Guideline Development Group (GDG) was enlarged with 6. Replantation of avulsed permanent teeth
representatives of the Belgian Association of Orthopaedics and 7. Periodontal treatment of aggressive periodontitis in the permanent
Traumatology, the European Bone and Joint Infection Society, the Belgian dentition
Society of Cardiology, the Belgian society for infectiology and clinical
microbiology (BVIKM – SBIMC) and the Belgian Antibiotic Policy 8. Periodontal abscess in permanent teeth
Coordination Committee (BAPCOC) in order to come to recommendations 9. Dental implant placement
supported by a multidisciplinary group of health professionals. Guideline
development and literature review expertise, support, and facilitation were 10. Extraction of permanent teeth
provided by the KCE expert team. The writing of the report, the conclusions 11. Antibiotic prophylaxis in patients at (high) risk of infective endocarditis
and the recommendations remain the sole responsibility of the KCE team. undergoing dental procedures
12. Antibiotic prophylaxis in patients with orthopaedic joint implants
2.2. Marking out the scope of the guideline
undergoing dental procedures
Currently, prescribers in the ambulatory sector do not have to specify for
In a following step, the research questions were further developed and the
which indication they prescribe antibiotics, so it is impossible to unravel
inclusion and exclusion criteria were defined using the PICO (Participants –
whether antibiotics are prescribed in a prudent way. Hence, we had to rely
Interventions – Comparator – Outcomes) framework (see Scientific Report,
on surveys among dentists to identify the indications for antibiotic therapy in
Appendix 3). This was discussed in depth with the members of the GDG and
the dental office.8-11 An initial list of 33 indications was reduced to 12 through
the stakeholders.
in-depth discussions with some members of the GDG. This list was then
presented to all members of the GDG and the dentists among the
stakeholders (see colophon) in an online survey. The results were discussed
with the GDG and stakeholders during the first joint meeting. Finally, it was
decided that the indication ‘Periodontal regenerative surgery’ was deleted
from the list of indications as this type of surgery is primarily performed by
periodontists and not by general dentists. On the other hand, the indication
8 Prudent prescription of antibiotics in the dental office KCE Report 332C

2.3. Systematic review of the literature Table 1 – Levels of evidence according to the GRADE system
Quality level Definition
In the scoping phase, a literature review was conducted, with special focus
on guidelines, Health technology assessments and systematic reviews High We are very confident that the true effect lies close to that of the
(Medline, Embase and dedicated websites). In addition, for each indication, estimate of the effect
a dedicated search was done for SRs, randomized controlled trials (RCTs) Moderate We are moderately confident in the effect estimate: the true
and, if indicated, other (primary) studies in Medline, the Cochrane Library effect is likely to be close to the estimate of the effect, but there
and Embase. The search strategies are outlined in the Supplement[LR1]. is a possibility that it is substantially different
Members of the GDG were also consulted to identify relevant network that Low Our confidence in the effect estimate is limited: the true effect
might have been missed during the search process. For all but one may be substantially different from the estimate of the effect
indication (i.e. non-surgical treatment of aggressive periodontitis), the Very low We have very little confidence in the effect estimate: the true
selection of records was done by two KCE researchers (of whom one effect is likely to be substantially different from the estimate of
dentist). the effect
Source: Balshem et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin
2.4. Quality assessment Epidemiol. 2011;64(4):401-6.16

The quality appraisal was performed using the Appraisal of Guidelines

Research and Evaluation (AGREE) II instrument for guidelines,12 the 2.5. Formulation of recommendations
AMSTAR 2 checklist for systematic reviews,13 the Cochrane Collaboration’s
tool for assessing risk of bias for RCTs,14 and the risk of bias in non­ To determine the strength of each recommendation, the GRADE
randomised studies of interventions (ROBINS-I) tool for observational methodology was followed (Table 2). The strength of a recommendation
studies.15 Critical appraisal of each study was performed by a single depends on the balance between all desirable and all undesirable effects of
researcher, and critically revised by a second researcher. an intervention (i.e. net clinical benefit), the quality of available evidence,
values and preferences, and the estimated cost (resource utilization). For
The GRADE approach was used to evaluate the quality of evidence (from this guideline, no formal cost-effectiveness study was conducted.
very low quality to high quality) for each outcome and study (Table 1); it
reflects the extent to which a guideline panel’s confidence in an estimate of
the effect was adequate to support a particular recommendation. The
evaluation was based on the following quality elements: study limitations,
inconsistency between studies, indirectness, imprecision and publication
bias. For each indication Summary of Findings tables are provided in the
Scientific Report, Appendix 11.
KCE Report 332C Prudent prescription of antibiotics in the dental office 9

Table 2 – Strength of recommendations according to GRADE or unclear (e.g. only proxy outcomes assessed) benefit from taking
Grade Definition antibiotics, the recommendation was formulated in the sense of a weak
recommendation. In case the evidence suggested no benefit or in case there
Strong The desirable effects of an intervention clearly outweigh the was no evidence, the recommendation was formulated as a strong
undesirable effects (the intervention is to be put into practice), or recommendation: antibiotics are not recommended.
the undesirable effects of an intervention clearly outweigh the
desirable effects (the intervention is not to be put into practice). In a few indications the use of antibiotics is indicated or can be considered.
Yet, for most of these indications there is insufficient high level evidence
Weak The desirable effects of an intervention probably outweigh the
undesirable effects (the intervention probably is to be put into which antibiotic (regimen) is to be preferred. From the perspective of the
practice), or the undesirable effects of an intervention probably prudent prescription of antibiotics, the expert group took the view that dental
outweigh the desirable effects (the intervention probably is not practitioners should at least get some advice on which antibiotic (regimen)
to be put into practice). could be considered in those situations. Therefore, clinical practice
Source: Andrews et al. GRADE guidelines: 15. Going from evidence to suggestions are given, which are based on indirect evidence. They are
recommendation-determinants of a recommendation's direction and strength. J Clin presented between blue lines, so that they can easily be distinguished from
Epidemiol. 2013;66(7):726-35.17 the recommendations (in red tables), which are evidence based.

A first draft of recommendations was prepared by the KCE researchers. The 2.6. External review
whole chapter (including evidence tables, summary of findings tables, The recommendations prepared by the GDG were circulated to relevant
recommendations, etc.) was circulated at least one week before the face-to­ professional and scientific associations (i.e. Belgian Association for
face expert meetings. During these meetings, the documents were Endodontology and Traumatology (BAET), Belgian Academy of Paediatric
discussed in depth, and, when indicated, revised. This was also applicable Dentistry (BAPD), professional and scientific associations of oral
to the recommendations. After the meetings, the revised documents (with maxillofacial surgeons (VBS-MKA - GBS-OMF, KBVSMFH - SRBSCMF),
changes well indicated) were shared with the GDG for final approval. No Belgian society for infectiology and clinical microbiology (BVIKM-SBIMC),
formal consensus procedure was used. Due to the restrictions imposed by Belgian Society of Periodontology (BVP), professional associations of dental
the national Security Council due to the Covid-19 pandemic, the last expert practitioners (CSD, SMD, VVT, VBT), professional associations of general
meeting had to be replaced by feedback by email. medical practitioners (Domus Medica, SSMG ), scientific association of
Given the important harms related to the intake of antibiotics, and given the dental practitioners (VWVT)), the sickness funds and other patient
fact that those were barely reported in the studies we included in the representatives (Test Aankoop – Test Achats, Ligue des Usagers des
systematic reviews, in the Scientific Report a dedicated chapter was devoted Services de Santé and Vlaams Patiëntenplatform), as well as to
to the adverse events associated with the use of antibiotics (Chapter 3). representatives of the Federal Agency for Medicines and Health Products
Indeed for antibiotics, the harms are both on an individual level (direct (FAGG – AFMPS; feedback received), the National Institute for Health and
adverse events) and a more long-term societal level (antimicrobial Disability Insurance (RIZIV – INAMI; feedback received), the Federal Public
resistance), which can eventually negatively impact the patient. When Service Health, Food Chain Safety and Environment (FOD VVVL – SPF
balancing benefits and risks, both the direct adverse events and SPSCAE), the Belgian Antibiotic Policy Coordination Committee (BAPCOC)
antimicrobial resistance were considered. For the benefits, the evidence for and the national One Health Advisor and Antimicrobial Resistance
most indications was low or very low. If the evidence suggested only minor Coordinator for their feedback.
10 Prudent prescription of antibiotics in the dental office KCE Report 332C

Declarations of interest of GDG members, validators and stakeholders were

formally recorded and listed in the colophon.
3. CLINICAL RECOMMENDATIONS
The systematic review of the literature which formed the basis for the clinical
2.7. Final validation recommendations, revealed that in most trials the primary outcomes related
to efficacy rather than harm. In order to compensate somehow for this
As part of the standard KCE procedures, an external scientific validation of underreporting, a special chapter was devoted to the side effects of
the report was conducted prior to its publication. This validation was done in antibiotics. It is intended for dental practitioners and other health care
two phases. First, the scientific content was assessed by two academic workers who consider the prescription of antibiotics for a dental problem, to
experts in the dental field on 11 September, 2020 (Vibeke Baelum and Ivor give thought to the potential deleterious effects carried with the use of
G. Chestnutt; see colophon for affiliation). Second, the methodology was antibiotics.
validated making use of the AGREE II checklist. This validation process was
chaired by the Belgian Centre for Evidence-Based Medicine (CEBAM) on Adverse events associated with the use of antibiotics may range from
16 September, 2020 (Martine Goossens, Patrick Vankrunkelsven, Gerda dizziness, nausea, vomiting, diarrhoea, candidiasis and headache to serious
Wauman). adverse events like major allergic reactions (including anaphylaxis), severe
toxicities and sudden death.18 Antimicrobials are able to harm patients by
various mechanisms. From a public health perspective, the development of
antimicrobial resistance is the greatest concern. But antimicrobials are also
associated with disruption of microbiomes, drug hypersensitivity reactions
and toxicities. The interested reader is referred to the Scientific Report,
Chapter 3.
The details of the evidence used to formulate the recommendations are
available in the Scientific Report, Chapter 4 and the related Appendices.

3.1. Symptomatic irreversible pulpitis in the primary dentition

Recommendation e Strength of Level of
Recommendation Evidence

• Given the fact that the administration of preoperative antibiotics in case of pulpitis in permanent teeth is not beneficial, the Strong Very low
use of antibiotics is not recommended in the pre-operative phase of pulpitis in primary teeth.

0903/39969 (Flanders), http://www.gardedentaire.be/ (Brussels) or

e During weekends and public holidays patients with urgent or emergency https://www.dentistedegarde.be/ (Wallonia).
dental conditions can contact the out of hours emergency dental service at
KCE Report 332C Prudent prescription of antibiotics in the dental office 11

3.2. Odontogenic abscess in the primary dentition

Recommendationse Strength of Level of
Recommendation Evidence
• Given the lack of any scientific evidence, the use of antibiotics is not recommended in children who present with an Strong Very low
odontogenic abscess without systemic involvement (e.g. fever, facial cellulitis, lymphadenopathy).
• In order to prevent the further systemic spread of pathogens, the use of antibiotics can be considered in children who Weak Very low
present with an odontogenic abscess with systemic involvement (e.g. fever, facial cellulitis, lymphadenopathy).

Clinical practice guidance:

In case antibiotics are considered, the following regimen is an option:
• Amoxicillin 75 - 100 mg/kg body weight/day, administered in 3 doses, for 5 days, or,
• In case of non-IgE mediated penicillin allergy: cefuroxime axetil (a second generation oral cephalosporin) 30 – 50 mg/kg body weight/day, administered in 3 doses, for 5
days, or,
• In case of IgE mediated penicillin allergy: azithromycin 10 mg/kg body weight/day, administered in 1 dose, for 3 days.

Children who present with a dental abscess at their general practitioner should be referred to a dentist for proper dental treatment (source control).

3.3. Symptomatic irreversible pulpitis in the permanent dentition

Recommendatione Strength of Level of
Recommendation Evidence
• The administration of antibiotics in patients with irreversible pulpitis in permanent teeth awaiting dental treatment, is not Strong Low
recommended.
12 Prudent prescription of antibiotics in the dental office KCE Report 332C

3.4. Symptomatic apical periodontitis and acute apical abscess in the permanent dentition
Recommendationse Strength of Level of
Recommendation Evidence

• The administration of antibiotics in patients with symptomatic apical periodontitis or acute apical abscess in combination Strong Very low
with dental treatment, is not recommended.

• Patients who present with symptomatic periapical periodontitis or an acute periapical abscess without systemic involvement Strong Very low
(e.g. fever, facial cellulitis, lymphadenopathy) should receive dental treatment without any delay. Currently, there is no
scientific evidence on the added value of systemic antibiotics in the meantime.
• In order to prevent the further systemic spread of pathogens, the use of antibiotics can be considered in patients who Weak Very low
present with a periapical abscess with systemic involvement (e.g. fever, facial cellulitis, lymphadenopathy).

Clinical practice guidance:

When antibiotics are considered in case of systemic involvement, the following regimen is an option:
• Amoxicillin 500 mg, three times a day for 3 - 7 days f, or,
• In case of penicillin allergy g: azithromycin 500 mg, once a day for 3 days or clarithromycin 500 mg, twice a day for 7 days.

The administration of antibiotics without proper endodontic treatment should be avoided.

Patients who present with a dental abscess at their general practitioner should be referred to a dentist for source control.

f This recommendations deviates from the BAPCOC guideline, which recommends “Amoxicillin 3 days, if no improvement of symptoms after endodontic treatment: amoxiclav
3-7 days”. Among the experts there was consensus that in severe cases 3 days of antibiotic treatment may not be sufficient. On the other hand, all experts agreed that in
case of no improvement of the symptoms, solely giving antibiotics with a broader spectrum is no good practice. In such cases further source control is indicated, hence
the patient should consult his dentist again (who may consider to prolong the antimicrobial therapy or broaden the spectrum).
g In case of penicillin allergy, the macrolides azithromycin or clarithromycin can be considered. While BAPCOC recommends in that case clindamycin
(https://www.bcfi.be/nl/chapters/12), this advice is not followed here. The rationale is that macrolides are less associated with Clostridioides difficile infection than
clindamycin (OR for clindamycin: 20.43, 95% CI: 8.50-49.09 vs. for macrolides: 2.55, 95% CI: 1.91-3.39).19 In addition, the susceptibility of oral streptococci to macrolides
is similar to that of clindamycin and macrolides are also quite active against oral anaerobes.20 Yet, it is important to mention that Azithromycin and Clarithromycin may
cause QT interval prolongations, which increases the risk of sudden cardiac death due to torsades de pointe.
KCE Report 332C Prudent prescription of antibiotics in the dental office 13

3.5. Replantation of avulsed permanent teeth

Recommendatione Strength of Level of
Recommendation Evidence
• The administration of systemic antibiotics at replantation of avulsed permanent teeth, is not recommended. Strong Very Low

3.6. Non-surgical treatment of aggressive periodontitis

Recommendation Strength of Level of
Recommendation Evidence

• The use of systemic antibiotics in combination with the non-surgical treatment of aggressive periodontitis can be Weak Low
considered.

Clinical practice guidance:

In case adjunctive antibiotics are considered, the following regimen is an option:
• The combination of amoxicillin 500 mg and metronidazole 500 mg, three times a day for 3 - 7 days, or,
• In case of penicillin allergy: metronidazole 500 mg, three times a day for 3 - 7 days.
The administration of antibiotics without proper periodontal treatment should be avoided.
14 Prudent prescription of antibiotics in the dental office KCE Report 332C

3.7. Periodontal abscess in the permanent dentition

Recommendationse Strength of Level of
Recommendation Evidence
• The use of antibiotics is not recommended in patients who present with a periodontal abscess without systemic involvement Strong Very low
(e.g. fever, facial cellulitis, lymphadenopathy). Also after adequate periodontal treatment the use of antibiotics is not
recommended.
• The use of antibiotics is not recommended in patients who present with pericoronitis without systemic involvement (e.g. Strong Very low
fever, facial cellulitis, lymphadenopathy). Also after adequate periodontal treatment the use of antibiotics is not
recommended.
• In the rare event that a patient presents with a periodontal abscess with systemic involvement (e.g. fever, facial cellulitis, Weak Very low
lymphadenopathy), the use of antibiotics can be considered.
• In order to prevent the further systemic spread of pathogens, the use of antibiotics can be considered in patients who Weak Very low
present with pericoronitis with systemic involvement (e.g. fever, facial cellulitis, lymphadenopathy, trismus, difficulty
swallowing).

Clinical practice guidance:

In case antibiotics are considered, the following regimen is an option:
• Amoxicillin 500 mg, three times a day for 3 - 7 days, or,
• In case of penicillin allergyg: Azithromycin 500 mg, once a day for 3 days or Clarithromycin 500 mg, twice a day for 7 days.

In the absence of trismus, the administration of antibiotics without proper (periodontal) treatment (e.g. debridement under local anaesthesia) should be avoided.

3.8. Dental implant placement

Recommendation Strength of Level of
Recommendation Evidence
• In order to reduce the number of (early) implant failures, the administration of preoperative antibiotics (i.e. a single dose of Strong Low
2 gram of amoxicillin 1 hour prior to surgery, if there is no known allergy) should be considered in case of dental
implant placement.

Clinical practice guidance:

In case of penicillin allergy, the following regimen is an option:
• a single dose of 600 mg clindamycin prior to surgery.
KCE Report 332C Prudent prescription of antibiotics in the dental office 15

3.9. Extraction of permanent teethh

Recommendation Strength of Level of
Recommendation Evidence
• The prophylactic administration of antibiotics in patients having a permanent tooth* extracted is not recommended. Strong Very low
* Two of the three included studies excluded wisdom teeth

3.10. Antibiotic prophylaxis in patients at (high) risk of infective endocarditis undergoing dental procedures
Recommendation Strength of Level of
Recommendation Evidence
• Prophylactic antibiotics can be considered in patients at high-risk of infective endocarditis undergoing invasive dental Weak Very low
procedures.
Invasive dental procedures* are those dental procedures that involve the manipulation of the gingival tissue or the
periapical region of teeth or the perforation of the oral mucosa.
The following patients are considered at high risk of infective endocarditis:
o Patients with a prosthetic valve or a prosthetic material used for cardiac valve repair;
o Patients with a history of infective endocarditis;
o Patients with congenital heart disease:
- Cyanotic congenital heart disease, without surgical repair, or with residual defects, palliative shunts
or conduits;
- Congenital heart disease with complete repair with prosthetic material whether placed by surgery or
by percutaneous technique, up to 6 months after the procedure;
- When a residual defect persists at the site of implementation of a prosthetic material or device by
cardiac surgery or percutaneous technique.
*According to the European Society for Cardiology (ESC) at risk dental procedures involve the manipulation of the gingival or periapical region of the teeth or perforation of the
oral mucosa (including scaling and root canal procedures). Antibiotic prophylaxis is according to the ESC not recommended for local anaesthetic injections in non-infected
tissues, treatment of superficial caries, removal of sutures, dental X-rays, placement or adjustment of removable prosthodontic or orthodontic appliances or braces, or following
the shedding of deciduous teeth, or trauma to the lips and oral mucosa. Last, the ESC remarks that there is no evidence to contraindicate implants in all patients at risk.21
Prophylactic antibiotics are not indicated in cardiac transplant recipients who develop cardiac valvulopathy,21 in patients who had a coronary artery bypass graft, nor in patients
who had coronary artery stents.

h As the current guideline focuses on the (prophylactic) administration of antibiotics within the frame of procedures performed in the general dental practice, third molar
extractions were considered out of scope.
16 Prudent prescription of antibiotics in the dental office KCE Report 332C

Clinical practice guidance:

In case antibiotic prophylaxis is provided, the following regimen is advised in adults:

• A single dose of 2 g amoxicillin or ampicillin 30 - 60 minutes before the dental procedure, or,
• In case of penicillin allergy: 600 mg clindamycin* 30 - 60 minutes before the dental procedure.
In case antibiotic prophylaxis is provided, the following regimen is advised in children:
• A single dose of 50 mg/kg amoxicillin or ampicillin 30 - 60 minutes before the dental procedure, or,
• In case of penicillin allergy: 20 mg/kg clindamycin 30 - 60 minutes before the dental procedure.
*: The risk of Clostridioides difficile infection after one single dose is very small.
Source: European Society for Cardiology (ESC)21

3.11. Antibiotic prophylaxis in patients with orthopaedic joint implants undergoing dental procedures
Recommendation Strength of Level of
Recommendation Evidence

• The administration of prophylactic antibiotics in patients with an orthopaedic joint implant who undergo dental procedures, Strong Very low
is not recommended.

4. ONGOING TRIALS AND RESEARCH

RECOMMENDATIONS
Chapter 5 of the Scientific Report provides a list of ongoing trials on the
indications under study. In addition, for each indication the evidence gaps
are listed and research recommendations are formulated.
KCE Report 332C Prudent prescription of antibiotics in the dental office 17

5. DISSEMINATION, IMPLEMENTATION prescribe too much than too little’), the importance attached to therapeutic
freedom and clinical autonomy, the lack of confidence in existing guidelines
AND UPDATE OF THE GUIDELINE and even the opposition to evidence-based medicine (‘each patient being
unique’).25, 27, 29-32 From the perspective of the patient and the general public
at large, qualitative and quantitative research indicates that the demand for
5.1. Dissemination & implementation
quick fixes, difficulties with accepting to manage self-limiting infections with
The content of this guideline is intended to be disseminated by national and simple rest and symptomatic treatment, the societal pressure to be healthy
international scientific and professional (dental) associations. Domus and performing, and presenteeism are into play.24, 28, 33
Medica and the Société Scientifique de Médecine Générale (SSMG) were
Implementation strategies should take psychological, social and institutional
both invited to the stakeholder meeting so that they can spread the content
determinants of behavioural change into account. Improvement strategies
of the guideline to general practitioners. The sickness funds and other
only have a chance of success when all types of barriers are targeted.34 For
patient representatives (Test Aankoop – Test Achats, Ligue des Usagers
this purpose, collaboration with the implementation cell of the Evidence
des Services de Santé and Vlaams Patiëntenplatform) were also invited so
Based Practice network is envisaged. In addition, the Belgian Centre for
that they can inform their clients (i.e. potential patients) about the content of
Pharmacotherapeutic Information (BCFI – CBIP) and the Federal Agency
the guideline. As all (but one) Belgian dental schools were represented in
for Medicines and Health Products (FAGG – AFMPS) will be contacted to
the GDG, it is hoped that the content of this guideline will be incorporated in
see how this guideline can be disseminated through their channels (e.g.
the academic teaching base on the prudent prescription and use of
website). Last, it will be discussed with the Research, Development &
antibiotics, as well as in the continuous education programmes for dental
Quality service of the National Institute for Health and Disability Insurance
professionals and general practitioners.
(RIZIV – INAMI), whether this guideline can be integrated in the following
Organisations can make attractive and user-friendly tools tailored for feedback to dentists. The feedback informs healthcare workers about their
implementation purposes. Yet, it is well known that the implementation of prescription behaviour; the feedback enables them to compare their own
guidelines on the prudent use of antibiotics is not easy to accomplish. prescription behaviour with their peers.
Evidence suggests that health care professionals are well aware of the
threat of antibiotic resistance, but for many this theoretical awareness is 5.2. Guideline update
difficult to translate in actual prudent prescribing behaviour.22, 23 Other
determinants are decisive in the decision to prescribe: e.g. perceived clinical In view of the fact that several clinical trials are running and that insights in
risks, the relationship with the patient, the perceived patient demand for antimicrobial resistance may change over time, this guideline should ideally
antibiotics (while research indicates that this demand is overrated),24-29 be updated every 5 years.
uncertainty avoidance, diagnostic uncertainty, time pressure, the idea that
over-using antibiotics presents fewer risks than limiting its use (‘it’s better to
18 Prudent prescription of antibiotics in the dental office KCE Report 332C

■ POLICY To the attention of the Minister of Health, the Federal Agency for Medicines and Health
Products and the National Institute for Health and Disability Insurance
RECOMMENDATIONSi Given the fact that the packages of antibiotics available on the Belgian market are larger
than what is needed for one treatment and in order to decrease the risk of keeping
leftovers at home and of subsequent self-medication, the recommendation “Put into
practice the delivery of the exact number of antibiotic tablets in pharmacies open to the
public” raised in KCE report 311, fully applies here.

To dentists and general practitioners, to their professional and scientific associations, the
universities, as well as to EBP-network:
Implement this guideline (o.a. through dissemination, promotion, inclusion in the teaching
base and continued education) and invest in a thorough communication between health
care provider and the patient.

To the Belgian Commission for the Coordination of Antibiotic Policy (BAPCOC):

Integrate this guideline in the BAPCOC AB guideline for ambulatory practice and in the
BAPCOC action plan 2020-2024.

i The KCE has sole responsibility for the recommendations.

KCE Report 332C Prudent prescription of antibiotics in the dental office 19

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COLOPHON
Title:
Guideline on the prudent prescription of antibiotics in the dental office – Short Report
Authors:
Roos Leroy (KCE), Jolyce Bourgeois (KCE), Leen Verleye (KCE), Dominique Declerck (KU Leuven), Pieter
Depuydt (UGent), Anouk Eloot (Private practice), Joana C Carvalho (Catholic University of Louvain), Wim
Teughels (KU Leuven), Rita Cauwels (UGent), Julian Leprince (Cliniques universitaires Saint-Luc), Selena Toma
(Cliniques universitaires Saint-Luc), Katleen Michiels (Private practice), Sam Aryanpour (Private practice), Astrid
Vanden Abbeele (Université Libre de Bruxelles), Mieke De Bruyne (UGent)

Co-author of section 4.10: Michel De Pauw (Belgian Society of Cardiology; UZ Gent)

Co-authors of section 4.11: Carl Brabants (Belgische Vereniging voor Orthopedie en Traumatologie; ZNA Middelheim, Antwerpen), Willem-
Jan Metsemakers (European Bone and Joint Infection Society; UZ Leuven), Jeroen Neyt (European Bone and
Joint Infection Society; UZ Gent)
Information specialist:
Nicolas Fairon (KCE)
Project facilitator:
Els Van Bruystegem (KCE)
Secretarial support:
Andrée Mangin (KCE)
Reviewers:
Marijke Eyssen (KCE), Vicky Jespers (KCE), Mattias Neyt (KCE), Sabine Stordeur
Stakeholders:
Patrick Bogaerts (Société de Médecine Dentaire (SMD)), Diederica Claeys (FAGG - AFMPS), Christian De Pauw
(Verbond der Vlaamse Tandartsen (VVT)), Peter Garmyn (Belgische Vereniging voor Parodontologie (BVP)), Lies
Grypdonck (RIZIV - INAMI), Edith Hesse (Union Nationale des Mutualités Socialistes), Claire Huyghebaert (Union
Nationale des Mutalités Libres), Koen Magerman (BAPCOC; Jessa Ziekenhuis, Hasselt), Wouter Reybrouck
(Vlaamse Beroepsvereniging Tandartsen (VBT)), Diane Van Cleynenbreugel (L’Académie Belge de Dentisterie
Pédiatrique), Martine Van Hecke (Test Aankoop), Eric Vandenoostende (Vlaamse Wetenschappelijke Vereniging
voor Tandartsen (VWVT))

External validators: Vibeke Baelum (Section Oral Epidemiology and Public Health, Department of Dentistry and Oral Health, Health,
Aarhus University) and Ivor G. Chestnutt (Dental Public Health, College of Biomedical and Life Sciences, Cardiff
University)
CEBAM assessors:
Martine Goossens, Patrick Vankrunkelsven, Gerda Wauman
Acknowledgements:
Mahmoud F. Yousef Abu-Taa (Arab American University-Jenin, Palestine), Lars Andersson (Health Sciences
Center Kuwait University, Kuwait City, Kuwait), Juliana Vilela Bastos (Federal University of Minas Gerais – (UFMG)
Brazil), Renato Casarin (The University of Campinas, Brasil), Leandro Chambrone (Ibirapuera University, Sao
Paulo, Brazil), Olalekan Gbotolorun (University of Lagos, Nigeria), Bengt Götrick (Malmö University, Sweden),
 Gary Greenstein (Columbia University, New York, USA), Frank Halling (Gesundheitszentrum Fulda, Germany),

Colwyn Jones (NHS Health, Scotland), Hossein Kashani (University of Gothenburg, Sweden), Paul Lambrechts

(KU Leuven), Charline Maertens de Noordhout (KCE), Pascal Meeus (INAMI – RIZIV), Kathleen B. Muzzin (Texas

A&M University, USA), Ian Needleman (UCL Eastman Dental Institute, UK), Ana Gisèle Piette (RIZIV – INAMI),

Ioannis Polyzois (Dublin Dental Hospital, Ireland), Hans Ragnar Preus (University of Oslo, Norway), Alfred Reader

(Ohio State University in Columbus, Ohio, USA), Dominique Roberfroid (KCE), Mario Romandini (University

Complutense of Madrid, Spain), Federica Romano (University of Turin, Italy), Dimitra Sakellari (Aristotle University

of Thessaloniki, Greece), Mariano Sanz Alonso (University Complutense of Madrid, Spain), France Vrijens (KCE)

Reported interests: Membership of a stakeholder group on which the results of this report could have an impact: Patrick Bogaerts

(President Société de Médecine Dentaire, asbl), Christian De Pauw (Board member Verbond der Vlaamse

Tandartsen, vzw), Michel De Pauw (President-elect of the Belgian Society of Cardiology 2021-2023), Peter

Garmyn (President Belgische Vereniging voor Parodontologie), Edith Hesse (Union Nationale des Mutualités

Socialistes), Jeroen Neyt (European bone and joint infection society (internal auditor)), Wim Teughels (Belgische

Vereniging Parodontologie)

Holder of intellectual property (patent, product developer, copyrights, trademarks, etc.): Wim Teughels (Holder of

4 patents for the use of pre-biotics for oral health)

Participation in scientific or experimental research as an initiator, principal investigator or researcher: Carl Brabants

(Clinical Outcome following Total Hip Arthroplasty with SMF-stem: A prospective consecutive series, multicentre

clinical study (Smith & Nephew)), Julian Leprince (Clinical study about irreversible pulpitis, see clinicaltrials.gov),

Jeroen Neyt (Topography and comparative study microbiome in periprosthetic infections), Wim Teughels (PI in

studies on the use of probiotics and guidance studies where probiotics are compared with AB)

Payments to speak, training remuneration, subsidised travel or payment for participation at a conference: Carl

Brabants (Course Chairman or Faculty of Courses on Hip & Knee Arthroplasty, organised by S&N, Host Surgeon

in the Visiting Surgeon Program of S&N), Jeroen Neyt (Zimmer biomet, consultant), Wim Teughels (Received for

KU Leuven speaker fees for lectures on probiotics)

Presidency or accountable function within an institution, association, department or other entity on which the results

of this report could have an impact: Patrick Bogaerts (President Société de Médecine Dentaire, asbl), Michel De

Pauw (Head of service cardiology, UZ Ghent), Peter Garmyn (President Belgische Vereniging voor

Parodontologie), Koen Magerman (President working group hospital care, BAPCOC), Wim Teughels (Department

periodontics, KU Leuven)

Layout: Ine Verhulst

Disclaimer: • The members of the guideline development group and the stakeholders were consulted during the
development of the scientific report. Their comments were discussed during meetings.
• Subsequently, a (final) version was submitted to the validators. The validation of the report results
from a consensus or a voting process between the validators. The validators did not co-author the
scientific report and did not necessarily all three agree with its content.
• Finally, this report has been approved by common assent by the Executive Board.
• Only the KCE is responsible for errors or omissions that could persist. The policy recommendations
are also under the full responsibility of the KCE.

Publication date:
18 November 2020
Domain:
Good Clinical Practice (GCP)
MeSH:
Dentistry, Practice Guidelines, Drug Prescriptions, Anti-Bacterial Agents, Antibiotic Prophylaxis
NLM Classification:
QV 350 Anti-bacterial agents (general or not elsewhere classified)
Language:
English
Format:
Adobe® PDF™ (A4)
Legal depot:
D/2020/10.273/22
ISSN:
2466-6459
Copyright:
KCE reports are published under a “by/nc/nd” Creative Commons Licence
http://kce.fgov.be/content/about-copyrights-for-kce-publications.

How to refer to this document? Leroy R, Bourgeois J, Verleye L, Declerck D, Depuydt P, Eloot A, Carvalho JC, Teughels W, Cauwels R, Leprince
J, Toma S, Michiels K, Aryanpour S, Vanden Abbeele A, De Bruyne M. Guideline on the prudent prescription of
antibiotics in the dental office – Short Report. Good Clinical Practice (GCP) Brussels: Belgian Health Care
Knowledge Centre (KCE). 2020. KCE Reports 332C. D/2020/10.273/22.
This document is available on the website of the Belgian Health Care Knowledge Centre.