Original Article

The Cleft Palate-Craniofacial Journal

1-6
Effectiveness of Presurgical Nasoalveolar ª 2021, American Cleft Palate-
Craniofacial Association

Molding Appliance in Infants With Article reuse guidelines:

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DOI: 10.1177/10556656211026493
Complete Unilateral Cleft Lip and Palate journals.sagepub.com/home/cpc

Thao Thi Nhu Dinh, DDS, MSD1, Dau Van Nguyen, DDS, PhD1,
Vu Hoa Anh Dien, DDS, PhD2 , and Tham Khac Dong, DDS, PhD3

Abstract
Objective: To assess the effectiveness of the presurgical nasoalveolar molding appliance among infants with unilateral cleft lip and
palate.
Methods: In this prospective study, 95 pairs of casts of infants with unilateral cleft lip and palate treated by presurgical nasoalveolar
molding were selected at the Children’s Hospital 1 at Ho Chi Minh City, Vietnam. The average time of treatment was 3 months.
All casts were scanned and measured using 3-dimensional technology before and after treatment. Paired t tests were applied for
comparisons.
Results: There was a statistically significant increase in the nostril height in cleft side (P < .001), decrease in the nostril width and
columella angle (P < .001), and decrease in cleft width and midline deviation (P < .001) after treatment with presurgical nasoal-
veolar molding appliance.
Conclusions: Nasoalveolar molding appliance is effective in improving the morphology of nostril and maxillary alveolar. Under-
standing this helps orthodontists and surgeons in treatment outcome expectations.

Keywords
cleft lip and palate, nasoalveolar molding appliance, facial growth, orthodontics, dental anomalies

Introduction presurgical molding of the cleft segments followed by surgical

Cleft lip and palate are among the most common congenital
craniofacial anomalies in developing countries. The incidence
of cleft lip and palate is approximately 1 per 700 newborns
(Bhuskute and Tollefson, 2016). The disease can affect the
entire life of patients including the appearance; difficulties in
feeding, speech, and hearing; and dental problems. Treatment
of cleft lip and palate starts from birth until adulthood and goes
through a lifelong multidisciplinary care journey. The goals of
presurgical nasoalveolar molding (NAM) are to align the
intraoral alveolar segments and to correct the deformed cleft
lower lateral cartilage (Yu et al., 2013).
It is important to improve the baby’s suckling function, help
the baby suckle easily, and limit the risk of choking on milk to
achieve adequate weight. As the weight of baby is not ade-
quate, the doctor will not be able to perform the surgery.
The standard treatment for the patients with cleft lip and palate
remains a matter of debate. There are 2 principal approaches:
one concerning surgical repair alone and the other concerning
repair. However, the therapeutic effect of the presurgical NAM
is still controversial. The theory of NAM treatment is based on
Matsuo’s research that the nasal cartilage is still developing
and subject to repositioning because of nasal flexibility within
the first 6 weeks of life (Matsuo and Hirose, 1991). Grayson
1
Odonto-Maxillofacial Surgery Department, Children’s Hospital 1, Ho Chi
Minh City, Vietnam
2
Department of Dental Public Health, Faculty of Odonto-Stomatology,
University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh
City, Vietnam
3
Department of Orthodontics, Faculty of Odonto-Stomatology, University of
Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
Corresponding Author:
Vu Hoa Anh Dien, Department of Dental Public Health, Faculty of
Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh
City, 652 Nguyen Trai, Ward 11, District 5, 749000 Ho Chi Minh City,
Vietnam.
Email: dienhoaanhvu@ump.edu.vn
2 The Cleft Palate-Craniofacial Journal XX(X)
et al. (1999) described the first NAM appliance. Many studies
have shown the effectiveness of NAM appliance including
narrowing the alveolar bone gap, receding protruding premo-
lars, creating symmetry of the nose, and elongating and recon-
structing the nasal columella (Grayson et al., 1999; Maull et al.,
1999). According to the study of Van der Heijden, the effec-
tiveness of the NAM appliance depends on the time of initia-
tion of treatment; therefore, it should be done as soon as
possible (Van der Heijden et al., 2013).
The objective of this study was to assess the effectiveness of
the NAM appliance among infants with unilateral complete
cleft lip and palate. The research results can help supplement
clinical evidence about the importance of early treatment of
oral clefts by NAM appliance.
Methods
Study Population
Ninety-five infants (63 boys and 32 girls) with unilateral cleft
lip and palate (UCLP) were recruited at the Children’s Hospital
1 at Ho Chi Minh City, Vietnam. This a referral center of
patients with cleft lip and palate serving population from Cen-
tral and South Vietnam. A comprehensive clinical assessment,
including facial and oral examination, was simultaneously per-
formed by the standardized craniofacial team. Inclusion criteria
included patients with a nonsyndromic, complete UCLP and
younger than 3 months at the start of NAM appliance. Exclu-
sion criteria included patients with any known syndromes,
bilateral cleft lip deformities, and incomplete or microform
unilateral cleft lip deformities. All lost casts were excluded.
Research Design
A prospective longitudinal study was performed. There was a pre-
and post-intervention comparison. There was no control group.
We used a passive type of presurgical infant orthopedics
(NAM appliance) which had been developed by Odonto-
Stomatology Department at Children’s Hospital 1. In our cen-
ter, unlike the original descriptions of the technique, the NAM
appliance involved placing nasal stent from the first day of
therapy. This design was used as well by studies of Subrama-
nian et al. (2016) and Ahmed et al. (2019). This research was
approved by the Independent Ethics Committee of Children’s
Hospital 1 (number 854/QD-BVND1) which is affiliated with
the Orthodontics Department, Faculty of Odonto-Stomatology,
University of Medicine and Pharmacy at Ho Chi Minh City,
Vietnam. All parents of participants provided written informed
consent for their information and images to be published.
Research Procedure
A maxillary impression was taken by an orthodontist aided by a
surgeon at the first examination (before primary lip repair sur-
gery). The impression was obtained with the infant fully awake
and without any anesthesia. A properly sized and fitted infant
acrylic tray was used in delivering the impression material.
The parents were advised they could allow the infants to cry
freely during the impression-making procedure. The Children’s
Hospital 1 setting allowed for a rapid response by an airway
team in case of an airway emergency. Impressions for the
maxillary casts were taken using a fast-setting alginate.
The plate was made with clear hard acrylic resin and then the
soft denture lining material was added to that plate.
The 1-step impression of the cleft-lip-palate-nose complex
was designed to save time, avoid harm to the child, and reproduce
the complex intraoral and extraoral anatomy in one plaster model.
The spaces were blocked with wax. We made a self-cure acrylic
plate of 15-mm thickness which was lined with soft tissue liner
22-gauge stainless steel wire and was fabricated, positioned ante-
riorly at an angle of approximately 45 to 50 to the plate.
Patients were kept under observation, and every 14th day of
visit the appliances were adjusted. An increase in nostril height
and a decrease in columella deviation (CD) angle were
achieved by combining force of the nasal stent and prolabial
taping. Parents were educated on handling and wearing of
appliances. They were also informed to add a thin layer of
Vaseline on the nasal stent at the time of every insertion.
The cast data were acquired by a 3D scanner (Open Tech-
nologies) which used a laser line triangulation scanner that
produced a 640  480 pixel 3D image. The data sets were
measured and analyzed with a special 3D viewer software
(Materialise). Reference points and lines that were based on
the anatomic structures were identified and digitized on the 3D
models. The linear, angular, and midline deviation; distance;
and area variables were measured (Table 1 and Figure 1).
The registration accuracy of the individual coordinates from
the measured points was +5 mm/100 mm, according to the
manufacturer. Reference points were digitized 4 times at a
2-week interval by examiners. Intraclass correlation coeffi-
cients (ICCs) for reference point identification were computed
to assess the interexaminer reliability as well as intraexaminer
reliability. Landmarks designs that indicate changes of nasal
morphology, and the maxillary alveolar shape and position
before and after treatment are shown in Table 1.
Statistical Analysis
Data analysis was performed in Stata version 12.0 (Stata Corp).
Differences in all variables before and after treatment were
tested by the paired samples t test. To reduce measurement
error, one week after the first measurements, 3 cases were
randomly selected and measured by the same examiner.
A P value of less than .05 was set as statistically significant.
Results
Among 95 samples, 73 (76.8%) cases were left-side clefts. The
age range of infants at the start of NAM appliance was from
3 to 91 days. The average pre-NAM age was 24.78 + 23.64
days and average post-NAM age was 98.73 + 7.70 days. The
range of total NAM treatment was from 87 to 115 days, with
nasal stent being placed on day 1 and continued for the entire
Dinh et al 3

Table 1. Definition of Landmarks and Measurements.

Abbreviation Definition
Landmarks
Sn Subnasale: Midline prolabium at the junction of the lip and columella
Pr Pronasal: The most anterior point of nose
Al Alar: Lateral most aspects of bilateral nasal alar
A/A’ (margin of the cleft) A point is the anterior end point of the noncleft segment. A’ point is the anterior end point of the cleft segment
I The intersection point between the labial-incisive papilla point line and the alveolar crest of the premaxilla in the
noncleft segment.
C/C’ (Canine points) Canine points are the intersection of the groove of the lateral labial frenum and the crest of the ridge
X Intersection of the transverse line from A’ (parallel to the baseline TT’) with the perpendicular from the baseline
to point A
Y Intersection of the transverse line from A’ (parallel to the baseline TT’) with the outline of the mesial border of the
noncleft segment
T/T’ The tuberosity and the crest of the ridge were outlined on the model and the junction of these line was called T and T’
J The central point of TT’
Measurements
CNH Distance from the highest point on the inner rims of the nostril to the alar base line
CNW Measurements were made connecting the midpoint of the columella base to the widest point of inner rims of
lateral ala
CD Deviation of the columella from a line perpendicular to a line connecting the alar bases
AA’ (cleft gap) Distance between point A and A’
AX Anteroposterior relation of cleft to noncleft segment. If the alveolar border of the cleft segment is positioned
anterior to the noncleft segment. this measurement is negative. Otherwise, a position measurement should be
anticipated
A’X Transverse and oblique width of anterior cleft which is the transverse relation of the cleft to noncelft segment.
When segments are separated at the alveolar cleft and A’ is farther from Y than X: the reading is positive. But
when the noncleft segment overlap the cleft segment and X is farther from Y than A’: the reading is negative
CC’ Intercanine width
TT’ Intertuberosity width
A-TT’ Anteroposterior maxillary alveolar length of the noncleft side
A’-TT’ Anteroposterior maxillary alveolar length of the cleft side
I-TT’ Total length of maxillary arch
I-ideal midline Transverse distance of the labial frenum deviation
IJ-ideal midline angle Midline deviation angle
ATT’ angle Rotation maxillary alveolar of the noncleft side
A’T’T angle Rotation maxillary alveolar of the cleft side

Table 2 showed significant increases in average nostril height

Figure 1. Three-dimensional surface of a maxillary cast with refer-
ence points marked. I: point of intersection between the alveolar ridge
and groove of the median labial frenulum. A and A’: cleft edges of the
ridges. C and C’: point of intersection between the alveolar ridge and
groove of the lateral labial frenulum. T and T’: tuberosity points.
treatment. Of the 95 cases, the majority (47%) was the infants
less than 2 weeks old. The assessment of the intra- and inter-
examiner reliability of reference point identification showed
excellent ICC values (Figure 2).
(CNH) in cleft side (from 1.18 + 0.38 mm to 6.84 + 2.16 mm,
P < .001) and significant decreases in average nostril width in cleft
side (from 20.93 + 1.51 mm to 19.08 + 1.48 mm, P < .001).
Significant changes were also seen in average CD in cleft side
(from 61.76 + 7.23 to 32.83 + 8.39 , P < .001). Infants with
complete UCLP always have a missing nasal floor, the nasal
cartilage on the cleft side tilted downward, and the tip of the nose
tilted to the cleft side. This research found that the nostrils on the
cleft side are slightly concave. The CD is always greater than 0 .
Other results regarding changes in maxillary alveolar and arch are
shown in Table 2.
Discussion
The normal growth of the facial skull led to an increase in the
nostril width. The nasal stent created active force on the nasal
wings on the cleft side to help shape the nose from the original
flat to the convex form as well as the noncleft side. This helps
narrow the nasal width on the cleft side. According to Grayson
4 The Cleft Palate-Craniofacial Journal XX(X)

and Shetye (2009), the nasal stent is inserted into the appliance
base when the gap is 5 mm to avoid mega nostril. However,
when the gap 10 mm, the time to narrow the cleft may exceed
the golden time to shape the nasal cartilage (6 weeks of age)
(Matsuo et al., 1984).
A major goal of cleft lip, alveolar, and palate treatment is to
improve the facial aesthetics and enhance the social accept-
ability of the individual in society. In this study, evaluation
of the extraoral casts demonstrated that NAM appliance
Figure 2. Intraclass correlation coefficients (ICC).
increased CNH and decreased CNW and CD (Yu et al.,
2013). The nasal stent repositioned the depressed alar cartilage,
correcting the flatted nasal tip, and the inferiorly displayed soft
triangle (Ezzat et al., 2007). In addition, NAM appliance helps
to improve nasal morphology in 2 directions (vertical and hor-
izontal) as it increases the nasal height and decreases the CD,
thereby increasing the symmetry of the nose after treatment.
The improvement of the height of the cleft nostril was corre-
lated with the time the appliance was applied (Ezzat et al.,
2007). The cleft gap at T0 was outstretched due to a contraction
of the orbicularis muscle and eventually lateral displacement of
2 segments with the pushing forces of the tongue fitting into the
cleft area (Baek and Son, 2006).
After treatment with NAM appliance, significant decreases
were found in AA’, AX, A’X, CC’, and labial frenum deviation
(I-ideal midline, IJ-ideal midline angle). The reduction cleft gap
leads to reducing the tension of the lip and makes surgery more
convenient to avoid excessive pulling scar after surgery.
Furthermore, the growth of maxillary alveolar is also influenced
by the level of the lip tension. Excessive tension will inhibit the
anterior growth of the maxilla. So, the cleft gap is narrowed to
make surgery simpler and reduce bone grafts in the future.
The position of point I changed after treatment because the
noncleft alveolar rotated in the direction of the gap. The
decrease in labial frenum deviation facilitates eruption of the
permanent teeth in the future. Similarly, the study of Shen et al.
(2015) found that the pretreatment labial frenum deviation of
5.64 + 1.84 mm decreased to 2.37 + 2.14 mm after treatment.
In this study, after treatment with NAM appliance, signifi-
cant increases were found in TT’. The evaluation of intraoral
casts demonstrated that the NAM appliance significantly
reduced the AA’ and increased TT’. The morphology of the

Table 2. The Changes Between Pre- and Post-NAM Appliance.

Before (T0) After (T1)

Measurementsa Mean + SD Mean + SD Changes P valueb
Extraoral
CNH 1.18 + 0.38 mm 6.84 + 2.16 mm Increase <.001
CNW 20.93 + 1.51 mm 19.08 + 1.48 mm Decrease <.001
CD 61.76 + 7.23 32.83 + 8.39 Decrease <.001
Intraoral
AA’ 1370 + 303 mm 4.45 + 3.57 mm Decrease <.001
AX 8.23 + 2.54 mm 3.37 + 2.35 mm Decrease <.001
A’X 12.78 + 3.00 mm 3.56 + 3.51 mm Decrease <.001
CC’ 31.95 + 2.59 mm 30.42 + 2.65 mm Decrease <.001
I/d 12.37 + 5.52 mm 3.67 + 2.58 mm Decrease <.001
IJ–d 31.83 + 11.28 12.03 + 9.16 Decrease <.001
TT’ 34.32 + 2.27 mm 36.27 + 2.38 mm Increase <.001
I–TT’ 24.68 + 2.53 mm 25.46 + 2.14 mm Increase .004
A–TT’ 26.29 + 2.12 mm 24.83 + 2.39 mm Decrease <.001
A’–TT’ 19.44 + 2.02 mm 21.71 + 2.00 mm Increase <.001
ATT’ 59.38 + 4.62 48.78 + 4.89 Decrease <.001
A’T’T 67.86 + 4.75 60.35 + 6.96 Decrease <.001
Abbreviations: NAM, nasoalveolar molding; SD, standard deviation.
a
Measurements are described in Table 1.
b
All results are based on paired sample t tests.
Dinh et al
Figure 3. Changes in morphology of alveolar.
dental arch was normalized without collapsing the dental
alveolar segments (Figure 3).
Baek and Son (2006) evaluated the effects of the NAM appli-
ance and the growth of 16 children with complete unilateral 3-
dimensional analysis (3D) models, by superimposing the film
before and after the treatment. The authors concluded that alveo-
lar molding effects took place mainly anteriorly during NAM
treatment and the growth of the cleft segments occurred mainly
posteriorly and after cheiloplasty. They found an increase in
intertuberosity width after treatment (28.97 + 2.58 mm to
29.29 + 2.84 mm).
Significant pre- to post-NAM decreases were seen in the
anteroposterior maxillary alveolar length of the noncleft side,
rotation maxillary alveolar of the noncleft side (A-TT’, ATT’
angle). Moreover, the length of the noncleft side before treat-
ment is greater than the total length of the maxillary arch. After
the treatment, we found that the length of the noncleft side is
less than the total length of the maxillary arch. This proves that
the length of the noncleft side changes in the direction of rota-
tion of the arch of the maxillary alveolar to the midline rather
than the forward growth (Table 2).
Significant pre- to post-NAM increases were seen in the
anteroposterior maxillary alveolar length of the cleft side, rota-
tion maxillary alveolar of the cleft side and total length of
maxillary arch (A’-TT’, A’TT’ angle, I-TT’; P < .001).
The maxillary alveolar cleft side arch rotated to the middle
as well as anteriorly.
In our research, 15 patients had mucosal ulceration which were
taping, and 5 patients had tissue irritation. Skin irritation, espe-
cially on the cheeks, should be reduced by applying skin barrier
tapes; position changed at least weekly after thorough drying. It is
also recommended to apply the dermal cream to decrease skin
irritation and moisturize the exposed cheek. Consider a tape hol-
iday and apply denture adhesive to appliance for retention (Bhus-
kute and Tollefson, 2016). Limiting nostril shape relapse is
anticipated (width 10%, height 20%, and CD 4.7%) at one year
of age. Moreover, nasal conformers are recommended for at least
6 months after treatment (Pai et al., 2005).
Conclusion
In this study, NAM therapy has been shown to be a successful
therapeutic mechanism among oral cleft infants for presurgical
5
cleft treatment. The authors found that NAM appliance could
effectively increase the nostril height in cleft side more than
5 times and decrease columella angle almost a half. NAM
appliance is effective in molding the maxillary dentoalveolar
arch decreasing cleft width and midline deviation approxi-
mately by two-thirds. The morphology of the maxillary alveo-
lar was normalized. The maxillary arch of the noncleft side was
modified by decreasing its projection and outward rotation.
Understanding this helps orthodontists and surgeons in treat-
ment outcome expectations.
Authors’ Note
This manuscript was presented orally at the 34th Annual Meeting of
the International Association for Dental Research—South East Asia
Division; November 26-27, 2020; Bangkok, Thailand.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to
the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship,
and/or publication of this article.
ORCID iD
Vu Hoa Anh Dien https://orcid.org/0000-0001-7229-3736
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