s00784 023 05119 7
s00784 023 05119 7
s00784 023 05119 7
https://doi.org/10.1007/s00784-023-05119-7
RESEARCH
Received: 18 January 2023 / Accepted: 8 June 2023 / Published online: 23 June 2023
© The Author(s) 2023
Abstract
Objective Passive alveolar molding (PAM) and nasoalveolar molding (NAM) are established presurgical infant orthodontic
(PSIO) therapies for cleft lip palate (CLP) patients. PAM guides maxillary growth with a modified Hotz appliance, while
NAM also uses extraoral taping and includes nasal stents. The effects of these techniques on alveolar arch growth have rarely
been compared.
Material and methods We retrospectively compared 3D-scanned maxillary models obtained before and after PSIO from
infants with unilateral, non-syndromic CLP treated with PAM (n = 16) versus NAM (n = 13). Nine anatomical points were
set digitally by four raters and transversal/sagittal distances and rotations of the maxilla were measured.
Results Both appliances reduced the anterior cleft, but NAM percentage wise more. NAM decreased the anterior and medial
transversal width compared to PAM, which led to no change. With both appliances, the posterior width increased. The alveo-
lar arch length of the great and small segments and the sagittal length of the maxilla increased with PAM but only partially
with NAM. However, NAM induced a significant greater medial rotation of the larger and smaller segment compared to
PAM with respect to the lateral angle.
Conclusions NAM and PAM presented some significant differences regarding maxillary growth. While NAM reduced the
anterior cleft and effectively rotated the segments medially, PAM allowed more transversal and sagittal growth.
Clinical relevance The results of this study should be taken into consideration when to decide whether to use PAM or NAM,
since they show a different outcome within the first few months. Further studies are necessary regarding long-term differences.
Keywords Nasoalveolar molding · Passive alveolar molding · Cleft lip palate · Presurgical orthodontics · Maxillary growth
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5002 Clinical Oral Investigations (2023) 27:5001–5009
and oral cavity to improve feeding and prevent the tongue Patients and methods
from expanding the palate cleft further. Another treatment
goal is to reduce the extent of the cleft and navigate the For this purpose, two patient cohorts from two German
growth of the alveolar segments. This navigation can be university cleft centres were compared in a retrospective
performed using active or more passive methods [2, 4]. An study. The PAM technique was being used exclusively at
example for an active or even invasive PSIO is the Latham the University Hospital Erlangen and the NAM technique
appliance, in which pins are placed in the alveolar bone. was being used exclusively at the Klinikum rechts der Isar
With these pins, the segments can then be actively drawn of the Technical University of Munich. To be included
towards each other [6, 7]. However, the use of invasive in the study, patients had to meet all of the following
PSIO techniques like Latham has decreased since studies criteria below.
showed they resulted in a higher frequency of anterior and
buccal cross-bite and anterior open bites [8, 9]. 1. Complete unilateral cleft lip palate
Two more passive and well-known PSIO techniques are 2. No association to a syndrome
passive alveolar molding (PAM), which uses a modified 3. Date of birth between 01.01.2010 and 31.12.2017
Hotz appliance [10, 11], and nasoalveolar molding (NAM) 4. Two high quality plaster models needed to be available,
according to Grayson [4, 12–16]. The principle of both one of the first week of life and one from the 10th to
techniques is to guide alveolar arch growth using func- 20th week of life (after PSIO, before lip surgery)
tional appliances (acrylic plates). This can be achieved by 5. Treatment with PSIO, either with PAM at the University
grinding out the plate in the area of the alveolus as well Hospital Erlangen or with NAM at the Klinikum rechts
as by adding acryl to certain areas of the plate. Treatment der Isar of the Technical University of Munich
with PAM solely uses passive growth guidance by direct- 6. Caucasian ethnicity
ing the movement of the alveolar segments using these
grinding strategies [10, 11]. On the other hand, NAM not Patient selection was not performed by the doctors that
only uses the grinding and adding strategy but also has performed the treatment to ensure that no bias would result.
a more active effect on the alveolus by using extraoral Patient selection was performed according to patients lists
taping on the cheeks, thus applying direct transversal and the presented inclusion criteria were investigated by one
forces on the lip segments and indirectly exerting pres- of the authors, who was not involved in patient treatment.
sure on the alveolar ridge [4, 12–14]. Additionally, NAM
also uses one extraoral nasal stent for uCLP malforma-
tion, which helps to form the flattened and asymmetrical PAM cohort
nostrils prior to lip surgery. In bilateral CLP cases, an
additional extraoral stent is used to extend the columella The patient cohort for the PAM therapy originated from
[4, 10, 14–18]. Overall, nasal cartilage is shaped best after the Dental Orthodontics Clinic of the University Hospital
birth due to high oestrogen levels [19]. Erlangen of the Friedrich-Alexander University Erlangen-
The effects of PAM and NAM treatment approaches have Nuremberg. All patients treated for CLP between 2010 and
been described and analysed individually in some studies and 2017 were inspected (n = 289). Patients without a com-
the effectiveness of the nasal stent in NAM has also been plete CLP were excluded, leaving 64 patients. Of these,
investigated in other studies [20–25]. However, so far, the only 33 patients had two plaster models, which were
possible differences between the two techniques in relation usable for the second treatment time point. Another 17
to the growth and change of the alveolar arch of the maxilla patients were excluded because they did not have a uCLP
have not been evaluated systematically in a comparative study or had a syndromale association of their uCLP, result-
design. Knowledge about the change in cleft width, the trans- ing in a total number of 16 patients with PAM therapy.
versal and sagittal growth and the rotation of the maxillary All patients fulfilling inclusion criteria with complete,
segments is of high value for orthodontists and cleft surgeons non-syndromic uCLP born between 2010 and 2017 were
alike. Hence, the aim of our study was to evaluate the effects selected (n = 16). The cohort consists of 7 female and 9
of PAM and NAM on alveolar arch parameters in infants with male patients. Detailed data about the patients’ charac-
unilateral, non-syndromic CLP, using 3D-scanned maxillary teristics is presented in supplementary Table 1. Ethical
models obtained in the first week of life and after completion approval was granted from the Ethics Committee of the
of the presurgical orthopaedics therapy before lip surgery. University of Erlangen (3_20Bc).
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Table 1 Anatomical and mathematically calculated points set on the maxilla by four raters
Abbreviation Measuring points Definition
Ps/Pg Pol points Anterior most mesial alveolar ridge point on the small and large segment, respectively; the
Anatomical point shortest connecting line in the anterior cleft region lies between the two points
C1s/C1g Mesial Caninus points Intersection of the lateral sulcus (mesial of the canine germ) and the highest point of the alveo-
Anatomical point lar ridge
Highest point mesial of the lateral sulcus
C2s/C2g Distal Caninus points Intersection of the lateral sulcus (distal to the canine germ) and the highest point of the alveolar
Anatomical point ridge
Highest distal point of the lateral sulcus
Tks/Tkg Tuber points Tuber points, most distal points of the alveolar ridge
Anatomical point
IP Interincisal point Intersection of the alveolar ridge line with the line connecting the incisive papilla and the
Anatomical point tectolabial frenulum
MT Centre point of the tuberial line Centre point between the tuber points (mathematically constructed by Excel)
Constructed point
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Measuring points
Transversal distances
Anterior cleft Pg-Ps
Anterior maxillary width C1g-C1s
Medial maxillary width C2g-C2s
Posterior maxillary width Tkg-Tks
Sagittal distances
Alveolar arch length great segment Pg-Tkg = Pg-IP + IP-
C1g + C1g-C2g + C2g-
Tkg
Alveolar arch length small segment Ps-Tks = Ps-C1s + C1s-
C2s + C2s-Tks
Sagittal maxillary length IP-Tkg-Tks
Rotations
Lateral angle of the great segment C1g-Tkg-Tks
Lateral angle of the small segment C1s-Tks-Tkg
Fig. 1 Points set and measured distances on example model in GOM-
Medial angle of the great segment Pg-MT-Tkg
Inspect; red: anterior cleft; blue: anterior (a), medial (b), posterior (c)
maxillary width; green: small (d) and great (e) alveolar arch length, Medial angle of the small segment Ps-MT-Tks
sagittal maxillary length (f)
Results
Table 3 shows the mean changes of PAM and NAM and com-
pares the pre- and post-treatment results for each technique as
well as comparing the two techniques. Figures 3 and 4 illus-
trate the variance of the changes. Both appliances reduced
the anterior cleft width significantly (PAM: − 3.25 mm;
NAM: − 4.70 mm; p ≤ 0.0001). If the change is considered
in mm, NAM reduced the cleft more than PAM, but the dif-
ference was not significant (p = 0.0968). However, if the
Fig. 2 Measured angles on example model in GOM-Inspect; black: percentage change is considered, there was a significant dif-
lateral angle of small (a) and great (b) segment; yellow: medial angle ference (p = 0.0227; NAM: − 50.35%, PAM: − 32.17%). This
of small (c) and great (d) segment
also revealed in the effect size which was 0.5750 calculated
for change in whole numbers, while it was 0.8267 calculated
Statistics for percentage change.
As for the maxillary transversal dimensions (Fig. 3), there
Both groups were initially examined if there was a statisti- was a significant difference in the change between the two
cal difference between the distances that were measured, appliances in the anterior and medial maxillary width (ante-
and to evaluate if the distances are comparable, for this, a rior: p = 0.0038, medial: p = 0.0003). While with PAM, the
t-test was performed. There was no statistical difference in anterior and medial maxillary width did not change signifi-
the distances that were measured (supplementary Table 3). cantly (− 0.07 mm, + 0.79 mm, respectively), NAM reduced
Then both cohorts were examined with a two-sided t-test, as both distances but only the anterior significantly (ante-
to whether changes in the calculated data were significantly rior: − 2.60 mm, p = 0.0330; medial: − 1.72 mm, p > 0.05).
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Table 3 Changes of distances/angles with PAM and NAM; p-value change to zero: significance of the change in the distance compared to no
change; comparison of change p-value: significance of the difference between the change in PAM and NAM; bold: significant p-values (p < 0.05)
Mean change in PAM Change to Mean change in NAM Change to Comparison
zero in PAM zero in NAM in change
p-value p-value p-value
Anterior cleft (mm) − 3.25 ± 2.30 < 0.0001 − 4.70 ± 2.77 < 0.0001 0.0968*
Anterior maxillary width (mm) − 0.07 ± 2.47 0.9160 − 2.60 ± 3.90 0.0330 0.0038
Medial maxillary width (mm) 0.79 ± 1.88 0.1152 − 1.72 ± 2.93 0.0557 0.0003
Posterior maxillary width (mm) 1.96 ± 1.69 0.0003 2.31 ± 2.14 0.0022 0.8351
Alveolar arch length great segment (mm) 5.77 ± 4.01 < 0.0001 3.03 ± 4.15 0.0218 0.0288
Alveolar arch length small segment (mm) 1.39 ± 2.50 0.0422 0.28 ± 3.69 0.7863 0.2736
Sagittal maxillary length (mm) 3.12 ± 2.35 < 0.0001 0.55 ± 2.41 0.4297 0.0030
Lateral angle great segment (°) − 3.78 ± 4.26 0.0029 − 9.01 ± 6.63 0.0004 0.0089
Lateral angle small segment (°) 0.17 ± 7.29 0.9281 − 4.62 ± 8.93 0.0864 0.0319
Medial angle great segment (°) 8.67 ± 5.82 < 0.0001 10.20 ± 6.13 < 0.0001 0.6606
Medial angle small segment (°) 1.84 ± 6.37 0.2667 2.10 ± 7.59 0.3388 0.6719
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With both appliances, a significant growth was seen in the also explain the smaller increase in the sagittal length of the
posterior maxillary width (NAM: + 2.31 mm, p = 0.0022; maxilla compared to PAM as well as the more significantly
PAM: + 1.96 mm, p = 0.0003), and thus there was no sig- reduced anterior cleft width. Looking at the same distances
nificant difference between NAM and PAM (p = 0.8351). in PAM, we found that the transversal anterior and median
Regarding the sagittal distances, significant differences distances did not show any change. Moreover, with PAM
between NAM and PAM were also detectable (Fig. 3). treatment the alveolar arch length of the great segment as
With PAM, the sagittal alveolar arch length of the great well as of the sagittal maxillary length increased signifi-
segment (p = 0.0288) and the sagittal length of the maxilla cantly more. This can be explained by the use of more pas-
(p = 0.0030) increased significantly compared to NAM. sive forces promoting more transversal and sagittal growth.
There was significant growth of the sagittal alveolar arch Moreover, the greater segments did not show such a pro-
length of the great segment with both appliances, however, nounced medial rotation and the smaller segment rotated
with PAM (+ 5.77 mm, p ≤ 0.0001) more than with NAM laterally with PAM. The reduction of these distances with
(+ 3.03 mm, p = 0.0218). While the sagittal length of the NAM comes of the greater rotation medial of the segments.
maxilla significantly extended using PAM (+ 3.12 mm, This can be seen by comparing the posterior maxillary
p ≤ 0.0001), the change in length was not significant using width, which is not affected by rotation. With both appli-
NAM (+ 0.55 mm). Further, with PAM, the sagittal alveo- ances, it showed similar amount of growth.
lar arch length of the small segment increased significantly Our results are in line with other studies that investigated
(+ 1.39 mm, p = 0.0422), while there was no significant elon- the maxillary growth of CLP patients with PSIO. They
gation using NAM (+ 0.28 mm). However, the difference reported that the medial transversal width is stable with
was not significant between NAM and PAM (p = 0.2736). PAM, while it is reduced with NAM, and that with both
Concerning rotation of the segments (Fig. 4), we meas- appliances, the posterior transversal width shows growth
ured a significant difference between NAM and PAM regard- [20–23]. Variations can be explained by differences in age
ing the lateral angles, with greater mesial rotation using at the second investigation period. A study from 2016 from
NAM (p < 0.04). While the great segment was significantly Cerón-Zapata et al. [31] compared maxillary growth in
rotated medially with both appliances (lateral measurements: CLP patients treated with a Hotz appliance and treated with
NAM: − 9.01°, p = 0.0004; PAM: − 3.78°, p = 0.0029; medial NAM. While the study of Cerón-Zapata et al. only meas-
measurements: NAM: + 10.20°, p < 0.0001; PAM: + 8.67°, ured distances, our study also measured rotations of the
p ≤ 0.0001), the small segment was rotated medially with segments. Comparing the distances measured in this study
NAM (− 4.62°) and laterally with PAM (+ 0.17°) but the and the study of Cerón-Zapata et al. showed similar results.
rotation for both was not significant. The distances, which show the biggest variation between
the two studies, are the sagittal alveolar arch length of both
segments, which show less growth in the study of Cerón-
Discussion Zapata et al. However, the measurement approaches were
slightly different. While our study measured the length on
The results showed that there are some significant differ- top of the alveolar ridge, Cerón-Zapata et al. measured on
ences between PAM and NAM concerning the growth and the medial side of the alveolar ridge. However, what all these
change in maxillary alveolar arch pattens. While for both studies do not show and measure are the rotation of the seg-
techniques a reduction of the anterior cleft width was found, ments. While in previous studies the rotations of the seg-
it was more pronounced with NAM. NAM also reduced the ments were rarely measured, and if no attention was given
anterior and medial width of the maxilla, while the posterior to it, this study shows significant differences in the rotations.
width increased in both groups. In contrast, with PAM, the These differences affect directly other length in growth of
anterior and median transverse width was stabilized and all the alveolar arch. This new finding needs to be taken into
sagittal parameters showed significant growth. Both seg- consideration when deciding which PSIO is the right one
ments rotated more medially using NAM than using PAM for the patient.
considering lateral angle measurements, while PAM reduced A strength of the study presented here is that the relevant
the collapse of the small segment to the medial. points were set by four and not only one rater, as done in
Summarizing the results, it is noticeable that some dis- other studies [20, 29]. Moreover, we performed preliminary
tances decreased with NAM, which did not change with trials with all four raters by setting different anatomical and
PAM such as the anterior and medial maxillary width. constructed points based on previous studies [20, 21, 29, 30].
This relates to the fact that with NAM, transversal forces In accordance to those preliminary trials, we excluded points
are applied using extraoral tape leading to a significantly that resulted in too much variation, and only included points
greater medial rotation of both segments and thereby reduc- that were set similarly by all four raters. Hence, it can be
ing these two distances. The enhanced medial rotation can assumed that the “fuzziness” for the points set in this study
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Clinical Oral Investigations (2023) 27:5001–5009 5007
is lower than in comparable studies. How much anatomical and sagittal growth can reduce lateral or anterior cross-bites
points variate between raters should be carefully investigated on the one hand and might diminish the need for secondary
in further studies, so that there is a ground how comparable orthodontic interventions in childhood and adolescence or
studies on the growth of the alveolar arch is. combined orthodontic-surgical treatment strategies in adult-
Since this is a retrospective study, one limitation is hood to correct those malocclusions and jaw misalignments.
that patients were not randomized to one of the patient Further studies need to evaluate if the induced changes
groups. In addition, one treatment centre (Erlangen) have a long-term effect on the alveolar arch growth and if
only performed PAM, while the other treatment cen- the differences between the two PSIO treatments still exist
tre (Munich) only performed NAM, which might have in youths or adults. Also, it should be evaluated if certain
caused a centre-related bias. Both centres, however, have patient subgroups benefit more from PAM, while others
a long experience in their treatment method. Another may benefit more from NAM. Hence, future studies should
limitation of this study is the relatively low number of focus on early life parameters enabling a decision for one
patients, which is due to the fact that complete non- of the presented treatment strategies after birth.
syndromic uCLP represent only one subtype of clefts in The relatively short treatment time with PSIO is due
a wide and very variable spectrum of cleft anomalies. to the fact that it is only used before the closure of the
This also leads to the fact that outliners can influence lip with 4–6 months of life. However, already after only
the results significantly. A higher case number would be a short treatment period, a significant difference can be
only possible with an extension of the study period or already seen between PAM and NAM. If this difference
additional cleft centres, which would lead to new sources still remains after several years need to be evaluated in a
of error and greater variability. A further limitation is the follow-up study.
lack of a control group, which would not have received
any PSIO treatment. Thereby, we could distinguish which
change was caused by PSIO treatment and which was
intrinsic. This is especially relevant for distances that Conclusion
showed growth. Some studies from the Netherlands sug-
gest that PSIO treatment only has a temporary effect on Our study showed that both PSIO techniques affect growth
the maxillary arch form. However, it is not clear which of the maxilla differently until lip closure. It is unclear
PSIO treatment was used in the randomized studies [32, whether these differences translate into different long-
33]. While in our study, we observed a significant medial term outcomes. Nevertheless, the short-term influence on
rotation with NAM compared to PAM over a mean of maxillary growth induced by PSIO should be taken into
15 weeks, the studies in the Netherlands observed no dif- account. However, follow-up studies should investigate
ference between PSIO treatment and no PSIO treatment, which patients benefit the most from which PSIO tech-
even in the short term. Thus, not all PSIO treatments may nique in the long-term and focus on early life parameters
have the same effect. A short-term difference between allowing informed individual treatment decisions after
NAM and PAM in the alveolar gap was also seen in a birth.
study of Gibson et al. However, this difference was gone
Abbreviations CLP: Cleft lip palate; uCLP: Unilateral cleft lip pal-
by the time of the palatoplasty [34]. Also, recent stud- ate; NAM: Nasoalveolar molding; PAM: Passive alveolar molding;
ies which compare NAM with an active PSIO show no PSIO: Presurgical infant orthopaedic therapies
long-term difference between the PSIO treatments [35].
A treatment decision needs to consider that the greater Supplementary Information The online version contains supplemen-
tary material available at https://d oi.o rg/1 0.1 007/s 00784-0 23-0 5119-7.
reduction of the cleft with NAM could have a positive effect
on the surgery, since with the reduction of the cleft, a pre- Acknowledgements We want to thank all the patients and patients’
surgical convergence of the soft tissues can be reached. This parents for allowing the usage of their plaster models and data for
might not only facilitate surgery but also help to reduce scientific use.
wound tension and postoperative scarring, which is illus- Author contribution RP singled out the patients and the plaster models,
trated as a positive effect in general surgical studies [2, 36]. scanned the plaster models, calculated the distances and angles and
Furthermore, the benefit of nasal molding and therefore wrote the manuscript. AR, CS, FG and KS set the points on the scanned
more symmetric cartilage shaping needs to be taken into plaster models. RS performed the statistical evaluation. AR, CS, FG,
KDW, KS, LG, LR and MK performed the treatments. All authors
account. On the other hand, in cleft patients with familial reviewed the manuscript.
transversal maxillary narrowness and/or sagittal deficiency
(class III malformation) or extreme narrowness of the max- Funding Open Access funding enabled and organized by Projekt
illa or collapse of the smaller segment to the median at birth, DEAL.
PAM might be a better option than NAM. Greater transversal
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5008 Clinical Oral Investigations (2023) 27:5001–5009
Data availability All relevant data is enclosed in the tables. 15. Grayson BH, Shetye PR (2009) Presurgical nasoalveolar moulding
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Robert Parhofer1 · Andrea Rau2 · Karin Strobel3 · Lina Gölz3 · Renée Stark4 · Lucas M. Ritschl5 · Klaus‑Dietrich Wolff5 ·
Marco R. Kesting1 · Florian D. Grill5 · Corinna L. Seidel6
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