PEDIATRIC/CRANIOFACIAL

Presurgical Nasoalveolar Molding for Cleft

Lip and Palate: The Application of Digitally
Designed Molds
Congcong Shen, M.D.
Caroline A. Yao, M.D.
William Magee III, M.D.,
D.D.S.
Gang Chai, M.D., Ph.D.
Yan Zhang, M.D.
Shanghai, China; and Los Angeles,
Calif.
Background: The authors present a novel nasoalveolar molding protocol by
prefabricating sets of nasoalveolar molding appliances using three-dimensional
technology.
Methods: Prospectively, 17 infants with unilateral complete cleft lip and palate
underwent the authors protocol before primary cheiloplasty. An initial nasoal-
veolar molding appliance was created based on the patients first and only in-
person maxillary cast, produced from a traditional intraoral dental impression.
Thereafter, each patients molding course was simulated using computer software
that aimed to narrow the alveolar gap by 1mm each week by rotating the greater
alveolar segment. A maxillary cast of each predicted molding stage was created
using three-dimensional printing. Subsequent appliances were constructed in
advance, based on the series of computer-generated casts. Each patient had a
total three clinic visits spaced 1 month apart. Anthropometric measurements
and bony segment volumes were recorded before and after treatment.
Results: Alveolar cleft widths narrowed significantly (p < 0.01), soft-tissue vol-
ume of each segment expanded (p < 0.01), and the arc of the alveolus became
more contiguous across the cleft (p < 0.01). One patient required a new appli-
ance at the second visit because of bleeding and discomfort. Eleven patients
had mucosal irritation and two experienced minor mucosal ulceration.
Conclusions: Three-dimensional technology can precisely represent anatomic
structures in pediatric clefts. Results from the authors algorithm are equivalent
to those of traditional nasoalveolar molding therapies; however, the number of
required clinic visits and appliance adjustments decreased. As three-dimensional
technology costs decrease, multidisciplinary teams may design customized naso-
alveolar molding treatment with improved efficiency and less burden to medi-
cal staff, patients, and families. (Plast. Reconstr. Surg. 135: 1007e, 2015.)
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

C
left lip and palate, a multifactorial con-
genital deformity, is characterized by three-
dimensional deficiencies in the midface and
arises with considerable variation in severity and
form.1 These heterogeneous clefts present a sig-
nificant challenge for surgeons, who coordinate
nasoalveolar molding appliances and surgery to
achieve the best possible functional and cosmetic
outcome.
From the Department of Plastic and Reconstructive Surgery,
9th Peoples Hospital of Shanghai, Shanghai Jiao Tong
University School of Medicine; and Division of Plastic and
Reconstructive Surgery, University of Southern California
Keck School of Medicine.
Received for publication May 5, 2014; accepted December
15, 2014.
Copyright 2015 by the American Society of Plastic Surgeons
DOI: 10.1097/PRS.0000000000001286
Orthodontic innovations have changed cleft
treatment paradigms by delaying surgery until alve-
olar and nasal structures have been premolded.
McNeil introduced the concept in 1950 by using a
series of acrylic plates to mold maxillary segments
into alignment.2 Georgiade and Latham (1975)
introduced a pin-retained appliance to simultane-
ously align the maxillary arches and expand the
posterior segments over a short period of time.
Subsequently, Hotz et al. described the use of a
passive orthodontic plate to slowly align the cleft
segments.
Matsuo and Hirose3 corrected nasal deformi-
ties using silicone nostril stents, as they showed
Disclosure: The authors have no financial interest in
any of the products or devices mentioned in this article.

www.PRSJournal.com 1007e
Copyright 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.

that nasal cartilage was still developing and sus-
ceptible to repositioning within the first 6 weeks
of life. Results were limited due to reliance on an
intact nasal floor for support.3 In 1993, Grayson et
al.4 introduced the modern presurgical nasoalveo-
lar molding appliance for patients with complete
cleft lip and palate. The appliance with nasal stents
and labial adhesive tape simultaneously corrects
alveolar and nasal deformities.4 The effectiveness
of Graysons nasoalveolar molding therapy has
been corroborated by numerous studies.59
Nasoalveolar molding systems decrease cleft
size by approximating the alveolar segments,
lengthening the columella, repositioning the phil-
trum, reshaping the nasal cartilages, and diverting
the tongue. The presurgical approximation of the
lip and alveolar segments minimizes lip tension
before and after cheiloplasty, thereby improving
both functional and aesthetic surgical results.
Presurgical closure of the alveolar gap enables
surgeons to perform a gingivoperiosteoplasty
at the time of primary lip repair. Furthermore,
gingivoperiosteoplasty may reduce the need for
secondary alveolar bone grafts during the period
of mixed dentition in more than 60 percent of
cases.10
Despite advantages of nasoalveolar molding
therapy, it is time consuming and burdensome
for the patient and family. Standard weekly visits
require making impressions, producing casts, con-
structing molding appliances, and fitting patients
with appliances. In addition, clinicians allocate a
great deal of time to making nasoalveolar molding
appliances and adjusting them. Therefore, nasoal-
veolar molding remains a form of long-term treat-
ment that requires a great deal of commitment
from cleft teams and families.
Given the inconveniences of current naso-
alveolar molding protocols, we propose a novel
computer and three-dimensional technology
for presurgical cleft treatment. Advances in digi-
tal imaging technology, such as computer-aided
design, computer-aided manufacturing, and
three-dimensional printing (rapid prototyping),
offer new applications for surgical planning.
Three-dimensional printing allows for precise
reproductions of complex figures based on medi-
cal imaging data (e.g., computed tomography and
magnetic resonance imaging). Recent advances
in metallic and plastic model production have
significantly increased construction speeds and
decreased costs for three-dimensional printing.
Three-dimensional imaging systems provide
a realistic representation of complex surfaces,
giving surgeons more anatomical data than
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Plastic and Reconstructive Surgery June 2015
previously available. Three-dimensional scanners
create a level of detail on the order of hundreds of
thousand of points (on a scale of microns) within
seconds.11 Kovacs et al.12 found that less than 7
percent of all three-dimensional scanned data
had a measurement error of greater than 2mm,
compared with reference measurements. Many
clinicians have found that this level of accuracy is
appropriate for plastic surgical applications.12
Once data have been scanned, they are incor-
porated into a computer-aided design system
where surgeons can observe and manipulate a
reconstructed computed tomography scan or
magnetic resonance image on a computer. Surgi-
cal planning, including osteotomies and soft-tissue
manipulation, can be simulated on computer-
aided design systems. In our study, each patients
nasoalveolar molding treatment was simulated
and presurgical orthodontics were constructed
based on the simulation.
In our study, an initial, pretreatment maxillary
impression was made of the patient and the cast
was scanned with a three-dimensional laser scan-
ner. The resulting image was manipulated using
computer simulation to approximate the alveo-
lar segments. Subsequently, a three-dimensional
printer was used to produce a series of maxil-
lary casts at projected points of the nasoalveolar
molding treatment. These casts were used as a
basis for constructing an entire series of molding
appliances in advance. We think that digitally
based maxillary mold manufacturing provides
consistency, qualitative control, and speed over
traditional clinic-based methods for constructing
nasoalveolar molding appliances.
PATIENTS AND METHODS
Patients and Procedures
A total of 17 infants (eight female and nine
male) with complete unilateral cleft lip and palate
were recruited prospectively from the Ninth Peo-
ples Hospital of Shanghai/Jiao Tong University
School of Medicine. Inclusion criteria were com-
plete unilateral cleft lip and palate, no congenital
syndromes involving the lip or palate, no previous
surgical or nonsurgical cleft treatment, and refer-
ral within the first 2 weeks of life.
Nasoalveolar Molding Therapy Protocol
Figure1 summarizes our nasoalveolar mold-
ing therapy protocol for all patients in the study.
At the initial clinic examination, silicone elas-
tomer impressions were made of the maxilla,
 Volume 135, Number 6 Digital Molds for Cleft Lip/Palate
Fig. 1. Algorithm of the three-dimensional nasoalveolar molding methodology.
including the palate and alveolus, using the pro-
cess described by Grayson and Cutting.13 Immedi-
ately thereafter, casts were constructed by a single
clinician, and three-dimensional images of the
casts were captured by a noncontact laser scan-
ning system (Vivid 910; Konica Minolta, Tokyo,
Japan). This system has a reported accuracy of
0.56 0.25mm and completes scans in approxi-
mately 10 seconds.14,15
Within 1 hour, three-dimensional computer
simulations were used to design and plan each
patients nasoalveolar molding treatment (Rapid
Form software, 2006; INUS Technology, Seoul,
Korea). The maxillary cast image was used to rec-
reate the patients anatomy on the computer, and
each step of alveolar segment molding was simu-
lated based on Graysons traditional nasoalveolar
molding protocol (i.e., eight to 10 steps to form
Copyright 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
a continuous, symmetrical arch) (Fig.2, above
and second row). After the treatment plan simula-
tion, maxillary models were created using a three-
dimensional printing system. Subsequently, the
same clinician constructed a series of appliances
using the computer-generated maxillary models
(Fig.2, third row and below). The custom appliances
were designed with a goal of reducing the alveolar
cleft width by 1mm each week. Treatment goals
were to rotate and align the greater and lesser alve-
olar segments. The appliances were made using a
combination of hard and soft acrylic resins.
Patients then returned to clinic the next day
to be fitted for their first appliance in the series.
The appliances were secured extraorally to the
cheeks bilaterally using surgical tape. Parents
were given an entire set of appliances for their
childs treatment course, and educated in how to
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 Plastic and Reconstructive Surgery June 2015

Fig. 2. Nasoalveolar molding therapy patient. (Above and second row) Computer simulation of alveolar segment
movement with nasoalveolar molding therapy. (Third row and below) The fabrication of a series of alveolar casts
using three-dimensional printing.

insert the appliances, when to progress to the next
appliance, and basic oral care. In addition, par-
ents were educated regarding how to recognize
complications such as erosion and bleeding. They
were also instructed to return to clinic if subse-
quent appliances were not easily inserted.
Patients came to the clinic once a month for
2 months to monitor appliance fit and treatment
progress. When the alveolar cleft was less than
5mm, silicone nasal stents were added as adjunc-
tive therapy to reshape the nasal cartilage and
create a narrower nasal base. Figure3 shows the
same patient before, during, and after nasoalveo-
lar molding appliance treatment.
line created the x-axis and the T-Q line created the
y-axis with the origin at point T. To confirm repro-
ducibility, the same investigator selected each of
the reference points and recorded measurements
on the maxillary casts 1 month apart. Paired
t tests confirmed that measurements were repro-
ducible (p < 0.01). Paired t tests were performed
on all anthropometric distances before and after
nasoalveolar molding therapy, with statistical sig-
nificance defined as p < 0.05 (SPSS v10.0; SPSS,
Chicago, Ill.). The number and duration of clinic
visits for each patient were recorded, along with
any procedures performed during the visit.

Data Collection and Analysis RESULTS

A set of previously validated anthropometric
distances16 (Table1) were measured on three-
dimensional computed tomography scans before
and after nasoalveolar molding treatment. Pre-
defined anatomical reference points were marked
to create a three-dimensional coordinate system to
calculate distances and volumes (Fig.4). The T-T
The mean patient age was 30 days (range,
10 to 50 days). Table1 summarizes paired t test
results of patient data before and after nasoal-
veolar molding therapy. Patients average alveo-
lar cleft width was 10.86mm and ranged from
7.1 to 15.2mm. No patients had small clefts (0
to 5mm), six patients had medium-sized clefts

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Copyright 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
 Volume 135, Number 6 Digital Molds for Cleft Lip/Palate
Fig. 3. A study patient before nasoalveolar molding (above),
wearing the appliance (center), and after treatment (below).
(5to10mm), and 11 had large clefts (10 to did not significantly change the configuration of
22mm). None had deficient-sized prenasoalve-
olar molding cleft segments or severe collapse or
rotation of the alveolus.
Linear Variables
The distance T-T between the most posterior
portions of the greater segment (greater seg-
ment) and lesser segment (lesser segment) did
not change significantly before and after treat-
ment, as is consistent with past studies.21,23 The
distance between the middle parts of greater
Copyright 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
segment and lesser segment (Q-Q) decreased
after treatment but without statistical signifi-
cance (p = 0.053). The width of the alveolar cleft
gap (P-P) showed a significant decrease in the
horizontal (x) axis (p < 0.001; Fig.5) and the
anteriorposterior (y) axis (p < 0.001), but there
was no significant difference in the vertical (z)
axis (p = 0.305).
The alveolar segments were divided into ante-
rior and posterior segments based on point C2
in the greater segment and C2 in the lesser seg-
ment. The anterior segment contains the primary
incisors and the posterior segment contains the
primary canines and molars. There was a signifi-
cant increase in anterior alveolar ridge length of
the greater segment (C2-I+I-P, p = 0.046), and a
nonstatistically significant increase in the lesser
segment (C2-P, p = 0.125). The posterior alveolar
ridge lengths also had a nonsignificant increase
in both the greater segment and lesser segment
(T-C2 and T-C2, p = 0.607 and p = 0.404, respec-
tively). The degree of midline deviation [I-Sag,
(O-I)-(T-T)] was significantly reduced after treat-
ment (p < 0 .001).
The vertical distance between the plane of
T-T-Q-Q and points P, P, and I were recorded
to calculate any inferior rotation of the greater or
lesser alveolar segments. There was no significant
inferior rotation/movement of the segments, with
p values of 0.91, 0.32, and 0.29, respectively.
Angular Variables
Rotational changes primarily occurred in the
greater segment. The angle between the anterior
portions of the greater segment [(P-T)-(T-T)]
were significantly reduced by therapy (p<0.001),
while the angle between the anterior portions of
lesser segment [(P-T)-(T-T)] did not show sig-
nificant changes (p = 0.088). The angle between
the anterior parts of te greater segment and
lesser segment [(C1-P)-(C1-P)] showed a signif-
icant increase (p < 0.001), likely from the mold-
ing forces on the lips and alveolus. Treatment
the greater segment (P-C2-T) or lesser segment
(P-C2-T).
Volume Variables
Volumes of the cleft jaw segments were divided
into the following segments: molar, canine, fron-
tal, and pole, as defined by planes perpendicular
to the model base that intersected with reference
points. During treatment, all segments in greater
segment and lesser segment continued to grow sig-
nificantly to varying degrees. The molar segments
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 Plastic and Reconstructive Surgery June 2015

Table 1. Anthropometric Variable Definitions and Values before and after Nasoalveolar Molding Treatment*
Before After
Maxillary Cast Measurement Definition Mean SD Mean SD p
Linear variables
Width between the most posterior ends of GS and LS T-T 31.45 2.06 30.44 1.47 0.100
Width between the middle parts of GS and LS Q-Q 26.34 1.68 25.05 1.98 0.053
Widths of the anterior cleft gap P-P 10.86 2.37 4.04 1.68 <0.001
P-P(X) 9.03 2.92 3.09 1.50 <0.001
P-P(Y) 5.08 1.34 1.25 1.06 <0.001
P-P(Z) 2.08 1.33 1.57 1.55 0.305
Anterior alveolar segment (C2-I) + (I-P) 20.91 2.87 22.66 1.97 0.046
C2-P 7.77 1.38 8.80 2.30 0.125
Posterior alveolar segment T-C2 16.36 2.37 16.87 3.01 0.607
T-C2 17.43 1.41 17.82 1.42 0.404
Midline deviation variables I-Sag 5.64 1.84 2.37 2.14 <0.001
(I -O)-(T-T) 76.47 6.15 87.35 9.04 <0.001
Alveolar segment superior/inferior movement (T-T-Q-Q)-P 4.25 1.73 4.31 1.28 0.910
(T-T-Q-Q)-P 3.10 1.11 3.46 1.02 0.335
(T-T-Q-Q)-I 1.31 0.85 0.98 0.92 0.290
Angular variables
Configuration of GS P-C2-T 103.23 7.38 86.77 5.53 <0.001
Configuration of LS P-C2-T 114.04 7.00 110.22 6.25 0.103
Angle of the anterior portions of GS (P-T)-(TT) 56.83 4.23 36.59 6.08 <0.001
Angle of the anterior portions of LS (P-T)-(T-T) 67.14 5.44 63.28 7.22 0.088
Angle between the anterior portions of GS and LS (C1-P)-(C1-P 122.19 6.55 147.77 11.50 <0.001
Volume of the alveolar segments
Greater segment
Pole segment P 23.03 5.37 34.76 6.78 <0.001
Front segment F 192.62 23.03 245.87 30.75 0.016
Canine segment C 177.41 9.01 185.34 10.43 0.346
Molar segment M 514.73 26.35 609.14 35.59 0.031
Lesser segment
Pole segment P 0.00 0.00 4.32 1.56 <0.001
Canine segment C 75.86 6.94 84.35 13.67 0.075
Molar segment M 445.61 17.98 532.14 27.58 0.015
GS, greater segment; LS, lesser segment.
*Boldface indicates statistical significance. Apostrophe denotes lesser segment. No apostrophe denotes greater segement.

showed the most growth while the canine segment

showed the least.

Clinic Visit Parameters

Fig. 4. Three-dimensional surface of a cast with reference points
marked. I, point of intersection between the alveolar ridge and
groove of the median labial frenulum; P and P, cleft edges of the
ridges; C1 and C1, point of intersection between the alveolar
ridge and groove of the anterolateral labial frenulum; C2 and C2,
point of intersection between the alveolar ridge and groove of
the lateral labial frenulum; Q and Q, intersection of the gingival
groove and lateral sulcus; T and T, tuberosity points.
The average time of nasoalveolar molding
treatment was 3 months, similar to those of tra-
ditional methods. The endpoint of therapy was
an alveolar cleft of less than 3mm. Patients in
this study required an average of four clinical vis-
its to achieve this treatment outcome. The aver-
age length of each initial visit was 120 minutes
because of impression making. The other visits
averaged 30 minutes each. Graysons nasoalveolar
molding and our three-dimensional molding pro-
tocols both average 3 months in duration. How-
ever, Graysons protocol requires seven to eight
60-minute biweekly clinic appointments.
Complications
At the initial appliance fitting, adjustments were
made to improve fit, but none of the appliances
required significant or complete reconstruction.

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 Volume 135, Number 6 Digital Molds for Cleft Lip/Palate
Fig. 5. Width of the alveolar cleft gap (P-P) before and after nasoalveolar molding therapy.
One infants premade appliance needed com-
plete reconstruction at the second visit due to
gingival bleeding and discomfort. In our cohort,
no patients experienced tissue necrosis. Two had
minor mucosal ulcerations and 11 had tissue irrita-
tion. No clinic appointments were missed.
DISCUSSION
Modern nasoalveolar molding therapy has
been shown to be a successful therapeutic mecha-
nism for presurgical cleft treatment. However, it
remains inefficient because it requires repeated
clinic visits, clinician/patient time, patient discom-
fort, and a rigorous commitment from the family.
This algorithm and time commitment may be dif-
ficult for families to adhere to. Improvements can
be made using modern technology. Available three-
dimensional technology can customize a treatment
algorithm that produces results equivalent to those
of existing nasoalveolar molding therapies but
improves patient/family satisfaction, as well as clini-
cal efficiency and data collection to quantify results.
Computer-aided design/computer-aided manu
facturing technologies were originally used in
mechanical engineering and are now used exten-
sively in orthopedic surgery, plastic surgery, oral
and maxillofacial surgery, and for dental prosthet-
ics.17,18 In these fields, three-dimensional technol-
ogy improves results by simulating treatments and
constructing templates. With micrometer accu-
racy,19 this technology can meet anatomic surgical
requirements and may negate the use of human
subjects or cadaver laboratories. Three-dimen-
sional technology is also widely used for the man-
ufacturing of customized prostheses, leading to
improvements in quality, production speed, and
patient satisfaction.20 We used our database of past
Copyright 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
dental models to help predict safe amounts of
rotation and movement. In our computer-aided
design/computer-aided manufacturing program,
we map out subsegments of the greater and lesser
alveolus and analyze each subsegments arc radius
to predict and plan the amount of rotation pos-
sible with nasoalveolar molding.
The literature has documented favorable out-
comes for presurgical orthodontics in nonsyn-
dromic unilateral cleft lip and palate.9,21 Ezzat et
al. reported that nasoalveolar molding therapy
achieved decreased alveolar cleft distances and
increased nasal symmetry.22 Many specialists agree
that it generally minimizes cleft width and reduces
the number of required nasal procedures.23,24 Our
results were consistent with those of previous stud-
ies.16,21 The posterior palate cleft size remained
constant, whereas the middle and anterior palate
clefts decreased in width. The morphology of the
lesser segment did not change, while the configu-
ration of greater segment bent concavely, probably
because the closure of the cleft was primarily due to
rotation of the noncleft segment. With our nasoal-
veolar molding algorithm, the laterally displaced I
point gradually moved toward midline as a result of
inward rotation of the greater segment, resulting in
an increase in anterior and posterior alveolar ridge
length. However, the change in posterior alveolar
ridge length did not reach statistical significance.
The volume of each segment increased to varying
extents and was consistent with results of previous
studies. The molar segment increased the most and
the canine segment increased the least; this is con-
sistent with anatomical expectations, because the
molar segment holds seven teeth germs and the
canine segment holds only one. Notably, inferior
rotation/displacement of the alveolar segments is
difficult to achieve with nasoalveolar molding. Our
1013e

results do not show a statistically significant differ-
ence in superior/inferior position of the anterior
portions of the alveolar segments.
The vectors of force in nasoalveolar molding
remain a challenge. We attempted to balance down-
ward and backward forces on the anterior portion
of the greater segment to maximize the rotational
effect on the greater segment to preserve the physio-
logic arch. Ideally, a purely rotational force best pre-
serves the physiologic arch by rotating the greater
segment to the lesser segment to align the anterior
segment with the facial midline. While we did not
purposely move the maxilla posteriorly, there may
be some unavoidable posterior movement with
Grayson nasoalveolar molding protocols that may
lead to class III or pseudoclass III occlusion.
Occlusion is a concern in the natural history
of patients with clefts because they are more likely
to have class III occlusion both with and without
nasoalveolar molding therapy. We tried to avoid
class III or pseudoclass III occlusion by not over-
rotating the greater segment [i.e., not reducing a
large (>10mm) cleft completely to zero]. Since
one of the primary objectives of nasoalveolar is
to help the surgeon achieve tension-free closure
with a natural soft triangle, reducing a wide cleft
to a 1- to 2-mm cleft is often surgically adequate.
Longer-term and case-control studies are needed
to determine whether this protocol significantly
worsens class III occlusion, compared to those
who did not receive nasoalveolar molding.
Cleft size did not affect whether nasoalveolar
molding treatment was offered. Rotation of the
greater segment aligns the bony support of the nasal
base, allowing the central incisors to erupt normally
beneath the midline. Patients of all cleft widths
can benefit from soft triangle and dome molding,
which is difficult to achieve through surgery alone.
Our complication rate was also consistent
with those reported for Graysons nasoalveolar
molding protocol but with improved symmetry
and patient compliance (100 percent). Grayson
discussed complications such as soft-tissue break-
down, intraoral ulcerations, patient noncompli-
ance, and neonatal tooth eruption, but did not
report the incidence.2 In a 27-patient case series
of complete unilateral cleft lip and palate, Gray-
son reported the following incidences: 7 percent
mucosal ulceration, 7 percent intraoral bleeding,
74 percent tissue irritation, 7 percent asymmetric
arches, and 30 percent missed appointments.25
Traditional nasoalveolar molding therapy
necessitates weekly adjustments by physician and
dental specialists and a great deal of time and com-
mitment by patients and families to complete the
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Copyright 2015 American Society of Plastic Surgeons. Unauthorized reproduction of this article is prohibited.
Plastic and Reconstructive Surgery June 2015
treatment.26 To ameliorate these challenges, our
system prefabricates maxillary casts so that clini-
cians can make a series of appliances in advance.
Our system significantly decreases the time it takes
to make the appliances and fit them to patients.
Computer-simulated nasoalveolar molding
therapy costs approximately 1300 RMB ($200US)
more versus Grayson therapy at our institution.
However, these costs may be recouped by fami-
lies who spend less time and resources on travel
for clinic appointments. Our therapy reduces the
number of visits by three to four, and reduces the
time spent in the clinic by 1.5 to 2 hours.
Our protocol made nasoalveolar molding
treatment possible for families living far away who
could not commit to weekly or biweekly clinic vis-
its. In addition, the fewer adjustments required
for computer-simulated appliances reduced the
emotional distress of the patients and families
who cope with the cumbersome process of tradi-
tional nasoalveolar molding.
Three-dimensional imaging offers a systematic
approach to measure reference points that leads
to more consistent measurements. Clinicians mea-
suring reference points on dental casts by hand
often have low measurement reproducibility and
a higher amount of measurement error.27,28
CONCLUSIONS
The use of three-dimensional technology in
nasoalveolar molding provides an efficient and
effective option for team-based cleft therapy. Our
protocol can significantly improve presurgical
cleft characteristics (e.g., increased soft-tissue vol-
ume, a narrowed cleft width, better-aligned alve-
olar segments, and improved nasal symmetry),
while decreasing the burden on patients, families,
and clinicians. With decreasing prices of three-
dimensional technology, families who previously
could not afford the time and cost of nasoalveolar
molding may gain access to care. Follow-up with
sequential three-dimensional scans of the face can
provide valuable data for the long-term growth
effects9,29 of our nasoalveolar molding protocol.
Gang Chai, M.D.
Department of Plastic and Reconstructive Surgery
9th Peoples Hospital of Shanghai
639 Zhi Zao Ju Road 200011
Shanghai, Peoples Republic of China
13918218178@163.com
patient consent
Parents or guardians provided written consent for
use of patients images.
 Volume 135, Number 6 Digital Molds for Cleft Lip/Palate
acknowledgments
This work was supported by the National Natural
Science Foundation of China (grant no. 81372097)
and the Shanghai Committee of Science and Technology,
China (grant no. 13DZ1108905 & 14441900802).
The authors acknowledge Simon Gamer, D.D.S. (clinical
professor, Division of Primary Oral Health Care, Ostrow
School of Dentistry of the University of Southern Cali-
fornia, Los Angeles, Calif.; attending prosthodontist,
Division of Pediatric Dentistry, Childrens Hospital, Los
Angeles, Calif.; and co-director, Nasal Alveolar Molding
Project at Childrens Hospital Los Angeles, Los Ange-
les, Cailf.), and John N. Groper, D.D.S., M.S. (clinical
professor, Pediatric Dentistry, Ostrow School of Dentistry
of the University of Southern California, Los Angeles,
Calif.; attending prosthodontist, Division of Pediatric
Dentistry, Childrens Hospital Los Angeles, Los Angeles,
Calif.; attending pediatric dentist, Division of Pediatric
Dentistry, Childrens Hospital Los Angeles, Los Angeles,
Calif.; and co-director, Nasal Alveolar Molding Project,
Childrens Hospital Los Angeles, Los Angeles, Calif.).
references
1. Fisher DM, Lo LJ, Chen YR, et al. Three-dimensional com-
puted tomographic analysis of the primary nasal deformity
in 3-month-old infants with complete unilateral cleft lip and
palate. Plast Reconstr Surg. 1999;103:18261834.
2. Grayson BH, Santiago PE, Brecht LE, Cutting CB. Pre-
surgical nasoalveolar molding in infants with cleft and pal-
ate, Cleft Palate Craniofac J. 1999;36:486498.
3. Matsuo K, Hirose T. Preoperative non-surgical over-correc-
tion of cleft lip nasal deformity. Br J Plast Surg. 1991;44:511.
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