NasoAlveolar molding treatment

protocol in patients with

cleft lip and palate
Pradip R. Shetye, and Barry H. Grayson

Presurgical infant orthopedics has been employed since 1950 as an

adjunctive neonatal therapy for the correction of cleft lip and palate. Most
of these therapies did not address deformity of the nasal cartilage in
unilateral and bilateral cleft lip and palate as well as the deficiency of the
columella tissue in infants with bilateral cleft. The NasolAveolar molding
(NAM) technique, a new approach to presurgical infant orthopedics,
developed by Grayson reduces the severity of the initial cleft alveolar and
nasal deformity. This enables the surgeon and the patient to enjoy the
benefits associated with repair of a cleft deformity that is minimal in severity.
This paper will discuss the appliance design, clinical management, and
biomechanical principles of nasolaveolar molding therapy. Long-term studies
on NAM therapy indicate better lip and nasal form, reduced oronasal fistula
and labial deformities, and 60% reduction in the need for secondary alveolar
bone grafting. No effect on growth of midface in sagittal and vertical plane
has been recorded up to the age of 18 years. With proper training and clinical
skills NAM has demonstrated tremendous benefit to the cleft patients as well
as to the surgeon performing the repair. (Semin Orthod 2017; 23:261–267.)
& 2017 Elsevier Inc. All rights reserved.

Introduction Brophy demonstrated the passing of a silver wire

P
through both the ends of the cleft alveolus, and
resurgical infant orthopedics has been used
then progressively tightened the wire to
in the treatment of cleft lip and palate
approximate the ends of the alveolus before
patients for centuries. Early techniques were
lip repair.4
focused on elastic retraction of the protruding
The modern school of presurgical orthopedic
premaxilla followed by stabilization after surgical
treatment in cleft lip and plate was started by
repair. In 1689, Hoffmann demonstrated the use
McNeil in 1950.5 He used a series of plates to
of facial binding to narrow the cleft and prevent
actively mold the alveolar segments into the
postsurgical dehiscence.1 A similar technique was
desired position. Burston,6 an orthodontist,
shown by Desault in 1790 to retract the maxilla
further developed McNeil0 s technique and
before surgical repair in patients with bilateral
made it popular. In 1975, Georgiade and
cleft repair.1 In 1844, Hullihen stressed the
Latham introduced a pin-retained active appli-
importance of presurgical preparation of clefts
ance to simultaneously retract the premaxilla and
using an adhesive tape binding.2 Esmarch and
expand the posterior segments over a period of
Kowalzig used a bonnet and strapping to stabilize
several days.7 Hotz et al.8 in 1987 described the
the premaxilla after surgical retraction.3 In 1927,
use of a passive orthopedic plate to slowly align
the cleft segments.
Hansjörg Wyss Department of Plastic Surgery, NYU Langone In 1993, Grayson et al.9 described a new
Medical Center, New York City, NY. technique to presurgically mold the alveolus,
Address correspondence to Pradip R. Shetye, DDS, MDS, lip, and nose in infants born with cleft lip and
Hansjörg Wyss Department of Plastic Surgery, 307 E 33rd St Lower
Level, New York City, NY 10016. E-mail: pradip.shetye@nyumc.org
palate. The original research on neonatal
molding of the nasal cartilage was performed
& 2017 Elsevier Inc. All rights reserved.
1073-8746/12/1801-$30.00/0 by Matsuo10–12 using silicon tubes to mold the
http://dx.doi.org/10.1053/j.sodo.2017.05.002 nostril. The NasoAlveolar Molding Appliance

Seminars in Orthodontics, Vol 23, No 3, 2017: pp 261–267 261

262 Shetye and Grayson

(NAM) consists of an intraoral molding plate oral cavity. The infant is held in an inverted
with nasal stents to mold the alveolar ridge and position to prevent the tongue from falling back
nasal cartilage concurrently. The objective of and to allow fluids to drain out of the oral cavity.
presurgical NAM is to reduce the severity of the The tray is seated until the impression material
original cleft deformity and thereby enable the reaches the posterior border of the impression
surgeon to achieve better repair of the alveolus, tray, but not beyond. The impression must
lip, and nose. Use of the NAM technique has also adequately cover the anatomy of the upper gum
eliminated surgical columella reconstruction and pads and palatal shelves and include the ves-
the resultant scar tissue in bilateral cleft lip and tibular folds. The clinician continuously observes
palate.13 NasoAlveolar molding has been shown the patency of the oral airway while the
to significantly improve the surgical outcome of impression material is setting. Once the
primary repair in cleft lip and palate patients impression material is set the tray is removed,
compared to other techniques of presurgical and the mouth is examined for residual
orthopedics.14 impression material. The impression is then
poured with dental stone to obtain an accurate
cast (Fig. 1).
Impression technique
Initial impression of the infant with cleft lip and
Appliance fabrication and design
palate is obtained within the first week of birth.
The parents/caregivers are asked to wait in the The molding plate is fabricated on the dental
waiting room while the baby is taken to the stone model. All the undercuts and the cleft
clinical operatory for the impression procedure. space are blocked with wax. The plate is made of
The intention of having the caregivers out of the hard clear self-cure acrylic. The borders are
clinical operatory during the impression proce- trimmed to remove sharp edges and points, then
dure is to remove any distraction from the a thin coat of denture soft material is applied.
treatment team should an airway emergency The plate must be 2–3 mm in thickness to pro-
occur. vide structural integrity and to permit adjust-
Heavy-bodied silicone impression material is ments during the process of molding (Fig. 1D).
used to take the initial impression. The impres- The borders in the place of the frenum and
sion is best taken in a clinical setting that is other attachments must be adequately relived.
prepared to handle airway emergency, if at all A retention button is fabricated and positioned
encountered. A surgeon is always present during anteriorly at an angle of approximately 401 to the
the impression process. The infant is held upside plate. This angle is adjusted or optimized to
down and the impression tray is inserted into the achieve maximum stability on the alveolar ridges.

Figure 1. (A) Infant held in inverted position during the impression process to prevent the tongue from falling
back and to allow fluids to drain out. (B) Impression of a unilateral cleft patient using custom tray and heavy-body
silicone impression material. (C) Plaster stone working model of a bilateral cleft patient for appliance fabrication.
(D) Bilateral nasoalveolar molding plate with retention buttons fabricated using self-cure acrylic resin.
 NasoAlveolar molding treatment 263

For the appliance employed in the treatment of a one end (Fig. 2). The use of skin barrier tapes on
unilateral cleft, only one retention arm is used. the cheeks like DuoDerm or Tegaderm is
The exact location of the retention arm is advocated to reduce irritation on the cheeks.
determined at the chair side. It is positioned so These barrier tapes remain on the cheeks for
as not to interfere with bringing the cleft lips several days while the surgical tapes and elastics
together. The vertical position of the retention are changed daily. The horizontal surgical tapes
arm should be at the junction of the upper and are quarter inch in width and about 3–4 in in
lower lip. Orthodontic elastics and tapes attached length. The elastic on the surgical tape is looped
to the retention button secures the molding plate on the retention arm of the molding plate and
in the mouth, resting on the alveolar ridges the tape is secured to the cheeks. The elastics
and palatal shelves. A small opening measuring (inner diameter 0.25 in wall thickness-heavy)
6–8 mm in diameter is made on the palatal should be stretched approximately two times
surface of the molding plate to provide an airway their resting diameter for proper activation force
in the event that the plate drops down of about 100 g. The amount of force could vary
posteriorly. The nasal stent is not fabricated at depending on clinical objective and the mucosal
this time. Instead its construction is delayed until tolerance to ulceration. The angle of these tapes
the cleft gap between the alveolar segments is vary according to the palatal plane angle but
reduced to about 5–6 mm in width. should be optimized to achieve retention of the
NAM appliance to the alveolar ridges and palatal
shelves. Additional tapes may be necessary to
Appliance insertion and tapping secure the horizontal tape to the cheeks. Parents
The molding plate is checked for over extension are instructed to keep the plate in the mouth full
especially in the area of the vestibular folds as time and to remove it for daily cleaning.
well as along the posterior border. Check for any They are instructed in how to examine their
sharp edges or rough surfaces that may irritate babies oral cavity looking for early stages of
the soft tissue. The appliance is then secured inflammation and provided with a way to reach a
extraorally to the cheeks and bilaterally by sur- member of the cleft palate treatment team so
gical tapes that have orthodontic elastic bands at that they may report it. The infant may require
time to adjust to feeding with the NAM appliance
in the first few days. The family does not leave the
treatment center until the baby has demon-
strated an ability to feed with the newly delivered
appliance in place.

Appliance adjustments
The baby is seen weekly to make adjustments to
the molding plate to bring the alveolar segments
together. In centers where the families live a
great distance from the treatment center,
adjustments may take place every 2 weeks. These
adjustments are made by selectively removing
the hard acrylic and adding soft denture base
material to the molding plate. No more than
1 mm of modification of the molding plate
should be made at one visit. The alveolar seg-
Figure 2. Unilateral cleft baby with NAM plate ments should be directed to its final and optimal
showing the retention arm positioned approximately position. Care must be taken to prevent the soft
401 down from horizontal to achieve proper activation
and to prevent unseating of the appliance from the denture material from building up on the height
palate. Note that there is no nasal stent placed for the of the alveolar crest as this will prevent complete
first few weeks of treatment. seating of the molding plate.
264 Shetye and Grayson

Incorporation of nasal stent adding the nasal stents. After adding the nasal
stents in bilateral cleft treatment, the attention is
The nasal stent component of the NAM appli-
focused on nonsurgical lengthening of the col-
ance is incorporated when the width of the
umella. To achieve this objective, a horizontal
alveolar gap is reduced to about 5 mm. The
band (columella band) of denture material is
rationale for delaying addition of the nasal stent
added to join the left and right lower lobes of the
is that as the alveolar gap is reduced, the base of
nasal stent, spanning the columella. The inferior
the nose and the lip segment alignment is also
surface of the columella bandsits at the nasolabial
improved. The alar rim, which at birth was
junction and helps to define this angle. The
stretched over a wide alveolar cleft deformity, will
superior surface of the columella band presses up
show some laxity as the cleft segments are
against the nostril apex, located at the top of the
brought together. Once the alar base on the cleft
columella. The columella band is gradually
side shows less stretch and tension, it can be
augmented at the superior and inferior surfaces,
elevated into symmetrical and convex form with
thus elongating the columella tissue. During this
the nasal stent and not be subjected to additional
phase of adjustments to the columella band the
stretch. When the nasal stent is introduced to a
nasal tip continues to be projected forward by
nostril that is overlying a very wide alveolar gap, it
augmentations to the upper lobes of the nasal
may stretch further the nostril rim and increase
stents. Tape is adhered to the prolabium
nostril circumference. This may result in a
underneath the horizontal lip tape and stretches
postsurgical “mega-nostril” or a nostril of greater
downward to engage the retention arm with
circumference on the cleft side than the noncleft
elastics . This vertical pull provides a counter
side. The nasal stent is made of 0.36 in round
stretch to the upward force applied to the left
stainless steel wire and takes the shape of a “Swan
and right nostril apex of the columella band.
Neck”.15 To appreciate the correct shape and
Taping downwards on the prolabium helps to
orientation of the wire stent one can use a roll of
lengthen the columella and vertically lengthens
soft wax and make a template seated on the
the often small prolabium. The horizontal lip
molding plate. The stent is attached to the labial
tape is added after the prolabium tape is in
flange of the molding plate, near the base of the
place.
retention arm. It extends forward and then
curves backwards (in the form of a swan neck)
entering 3–4 mm past the nostril aperture. As the Primary surgical repair of the alveolus lip
wire extends into the nostril, it is curved back on and nose
itself to create a small loop for retention of the
The alignment of alveolar segments and pre-
intranasal portion of the nasal stent. The hard
maxilla, correction of nasal asymmetry, elonga-
acrylic component is shaped into a bi-lobed form
tion of the columella and projection of the nasal
that resembles a kidney. A layer of soft denture
tip are accomplished before the primary surgical
liner is added to the hard acrylic for comfort. The
repair. Surgical closure of the lip and nose is
upper lobe enters the nose and gently projects
performed from 3 to 4 months of age.16–18
the dome forward until a moderate amount of
Achievement of presurgical clinical objectives
tissue blanching is evident. The lower lobe of the
in patients with bilateral cleft lip and palate tends
stent lifts the nostril apex and defines the top of
to take 1–2 additional months. The duration of
the columella (Fig. 3).
molding therapy could also vary depending on
the severity of the initial cleft deformity.
The surgical technique must be modified to
Nonsurgical columella lengthening in
take advantage of the NAM preparation.
patients with bilateral cleft lip and palate
Approximation of the alveolar segments permits
In patients with bilateral cleft lip and palate, the surgeon to perform gingivoperiosteoplasty.
there is a need for two retention arms as well as Reshaping of the deformed alar cartilage and
two nasal stents, which are similar in shape to the stretching of the nasal mucosa enhances the
unilateral stent. The initial goal of molding is to surgeons ability to achieve a good primary rhi-
center the premaxilla, retract the premaxilla and noplasty and surgical alveolar repair. Appro-
reduce the bilateral cleft gaps to 5–6 mm prior to priate modification of the surgical technique will
 NasoAlveolar molding treatment 265

Figure 3. (A)Figure showing the design of the nasal stent and the position of the nasal stent in the nostril.
(B) Unilateral NAM plate with nasal stent showing lip taping. (C) The bilateral NAM plate in position showing the
tape adhered to the prolabium and stretched to the plate and attached to the plate.

improve the long-term retention of the surgical how to recognize and manage early signs of
repair. irritation. The intranasal lining of the nasal tip
can become inflamed if too much force is
applied by the upper lobe of the nasal stent. The
Complications
area under the horizontal prolabium band can
The most common problems observed during become ulcerated if the band is too tight.
NAM therapy are irritation to the oral mucosa, Another area of tissue irritation is the cheeks.
gingival tissue, or nasal mucosa. Intraoral tissues Extreme care should be taken while removing
may ulcerate from excessive pressure applied by the cheek tape to avoid any irritation to the skin.
the appliance. These are commonly found in the Skin barrier tapes like Tegaderm are recom-
oral vestibule and on the labial side of the pre- mended. Slight relocation of the position of the
maxilla. The oral and the nasal cavities of the tape during treatment is also recommended to
infant should be carefully examined on each visit provide rest to the tissues in case they become
for ulceration and appropriate adjustments irritated. It is also recommended that aloe vera
should be made to the molding plate to relieve gel be applied to the cheeks when changing
sore spots. The parents should be instructed in tapes.
266 Shetye and Grayson

Discussion 2. Goldwyn RM. Simon P. Hullihen: pioneer oral and plastic

surgeon. Plast Reconstr Surg. 1973;52(3):250–257.
There are several benefits of the nasolaveolar 3. Millard DR Jr(Ed.). Cleft craft.The Evolution of its Surgery.
molding technique in the treatment of cleft lip Boston: Little Brown; 1980.
and palate deformity. Proper alignment of the 4. Brophy TW. Cleft lip and cleft palate. J Am Dent Assoc.
1927;14:1108.
alveolus, lip, and the nose helps the surgeon to 5. McNeil C. Orthodontic procedures in the treatment of
achieve a better and more predictable surgical congenital cleft palate. Dent Rec. 1950;70:126–132.
result. The cleft deformity is significantly reduced 6. Burston WR. The early orthodontic treatment of cleft
in size with the NAM therapy before surgery palate conditions. Dent Pract. 1958;9:41.
making primary repair of the lip, alveolus, and 7. Georgiade NG, Latham RA. Maxillary arch alignment in
the bilateral cleft lip and palate infant, using pinned
the nose a less effortful procedure. Approx- coaxial screw appliance. Plast Reconstr Surg. 1975;56(1):
imation of the alveolar process before surgery 52–60.
also enables the surgeon to perform gingivo- 8. Hotz M, Perko M, Gnoinski W. Early orthopaedic
periosteoplasty successfully. Long-term studies of stabilization of the praemaxilla in complete bilateral
NAM therapy indicate that the change in nasal cleft lip and palate in combination with the Celesnik lip
repair. Scand J Plast Reconstr Surg Hand Surg. 1987;21(1):
shape is stable with less scar tissue and better lip 45–51.
and nasal form.19 This improvement reduces the 9. Grayson BH, Cutting C, Wood R. Preoperative columella
number of surgical revisions for excessive scar lengthening in bilateral cleft-lip and palate. Plast Reconstr
tissue, oronasal fistulas, and nasal and labial Surg. 1993;92(7):1422–1423.
deformities.20 With the alveolar segments in 10. Matsuo K, Hirose T. Nonsurgical correction of cleft lip
nasal deformity in the early neonate. Ann Acad Med
better position and increased bony bridges Singapore. 1988;17(3):358–365.
across the cleft, the permanent teeth have a 11. Matsuo K, Hirose T, Otagiri T, Norose N. Repair of cleft
better chance of eruption into good position with lip with nonsurgical correction of nasal deformity in the
adequate periodontal support.21 Studies have early neonatal period. Plast Reconstr Surg. 1989;83(1):
also demonstrated that 60% of patients that 25–31.
12. Matsuo K, Hirose T. Preoperative non-surgical over-
underwent NAM and gingivoperiosteoplasty did correction of cleft lip nasal deformity. Br J Plast Surg.
not require secondary bone grafting.22 The remain- 1991;44(1):5–11.
ing 40 % that did need secondary alveolar bone 13. Grayson BH, Santiago PE, Brecht LE, Cutting CB.
grafts showed more bone remaining in the graft Presurgical nasoalveolar molding in infants with cleft
site compared to patients who have had no lip and palate. Cleft Palate Craniofac J. 1999;36(6):486–498.
14. Grayson BH, Cutting CB. Presurgical nasoalveolar ortho-
gingivoperiosteoplasty.21 Fewer surgeries also pedic molding in primary correction of the nose, lip, and
results in substantial cost savings for families alveolus of infants born with unilateral and bilateral clefts.
and insurance companies.20,23 Lee at al.24 Cleft Palate Craniofac J. 2001;38(3):193–198.
demonstrated that midfacial growth in the 15. Grayson BH, Maull D. Nasoalveolar molding for infants
sagittal and vertical plane was not affect by born with clefts of the lip, alveolus, and palate. Clin Plast
Surg. 2004;31(2):149.
NAM and gingivoperiosteoplasty. Sischo et al.25 16. Cutting CB, Bardach J, Pang R. A comparative study of the
showed a significant decrease in caregiver anxiety skin envelope of the unilateral cleft lip nose subsequent to
and increased sense of empowerment among rotation-advancement and triangular flap lip repairs. Plast
caregivers in a prospective multicenter clinical Reconstr Surg. 1989;84(3):409–417.
trial that elected to perform NAM vs caregivers 17. Cutting C, Grayson B. The prolabial unwinding flap
method for one-stage repair of bilateral cleft-lip, nose,
who did not have their child undergo NAM. and alveolus. Plast Reconstr Surg. 1993;91(1):37–47.
Since the initiation of NAM there has been a 18. Cutting C, Grayson B, Brecht L. Columellar elongation in
significant difference in the outcome of primary bilateral cleft lip. Plast Reconstr Surg. 1998;102(5):
surgical cleft repair. With proper training and 1761–1762.
clinical skills NAM has demonstrated 19. Maull DJ, Grayson BH, Cutting CB, Brecht LL, Bookstein FL,
Khorrambadi D, et al. Long-term effects of nasoal-
tremendous benefit to the cleft patients as well veolar molding on three-dimensional nasal shape in
as to the surgeon performing the primary repair. unilateral clefts. Cleft Palate Craniofac J. 1999;36(5):
391–397.
20. Patel PA, Rubin MS, Clouston S, Lalezaradeh F, Brecht
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 NasoAlveolar molding treatment 267

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Cutting CB. Success Rate of Gingivoperiosteoplasty with unilateral cleft alveolus. Cleft Palate Craniofac J. 2002;39
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Secondary Alveolar Bone Grafts Alone. Plast Reconstr 24. Lee CTH, Grayson BH, Cutting CB, Brecht LE, Lin WY.
Surg. 2008;121(4):1356–1367. Prepubertal midface growth in unilateral cleft lip
22. Santiago PE, Grayson BH, Cutting CB, Gianoutsos MP, and palate following alveolar molding and gingivoper-
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