Nasoalveolar Molding for Unilateral and Bilateral Cleft

Nasoalveolar Molding forUnilateral and Bilateral
Cleft Lip Repair Hitesh Kapadia, DDS, PhDa,*, Douglas Olson, DMD, MSb, Raymond Tse, MDa,Srinivas M. Susarla, DMD, MD, MPHa
KEYWORDS

� Cleft lip � Cheiloplasty � Nasoalveolar molding � Presurgical infant orthopedics

KEY POINTS

� Nasoalveolar molding (NAM) is an effective tool for both unilateral and bilateral cleft lip repair.

� In the unilateral cleft lip, NAM appliances act to reduce the gap between the greater and lesser seg-ments and the corresponding lip elements, realign the cleft alar base, elevate the cleft-sided lowerlateral cartilage, and straighten the deviated columella.

� In the bilateral cleft lip, NAM functions to reorient the ectopically positioned premaxilla toward themidline and expand the alveolar segments as needed. The nasal form is improved by molding thelower lateral cartilages to achieve symmetry and elongating the columella to increase projection ofthe nasal tip.

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BACKGROUND

Presurgical infant orthopedics is a collective termto describe a treatment method or appliancedesigned to lessen the severity of the cleft defor-mity before primary cheiloplasty and rhinoplasty.The first descriptions of these appliances dateback to the seventeenth century. Most of the earlyappliances sought to retract the protrusive maxillawith an external appliance. With these, there wasminimal change to the alveolar segments. Begin-ning with McNeil’s molding plate described in the1940s to 1950s, there have been several tech-niques designed to reposition the alveolar seg-ments.1–5 They range from lip taping to thepin-retained Latham appliance, which retractsthe premaxilla and expands the posterior alveolarsegments. However, none of these directly affectthe primary nasal deformity that characterizes cleftlip and palate. As the most visible manifestation ofcleft lip and palate, it can present a significant

Funding: There was no funding for this work.a Seattle Children’s Hospital, Craniofacial Center, 4800 Sb Craniofacial Center of Western New York, Oishei ChildNY 14203, USA* Corresponding author. Seattle Children’s Hospital, Cran9.520, Seattle, WA 98145.E-mail address: [email protected]

Oral Maxillofacial Surg Clin N Am 32 (2020) 197–204https://doi.org/10.1016/j.coms.2020.01.0081042-3699/20/� 2020 Elsevier Inc. All rights reserved.

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surgical challenge and it is common for patientsto undergo multiple surgical procedures toimprove nasal form. This problem led Graysonand colleagues6–18 in 1993 to develop an appli-ance that is able to shape the nasal cartilage whilealso molding the alveolar process. The technique,termed nasoalveolar molding (NAM), has beenshown to improve nasal cartilage symmetry andincrease columella length. Since it was originallydescribed, NAM has become a mainstay for thepresurgical management of children born withcleft lip and palate.

GOALS OF NASOALVEOLAR MOLDING

The primary goal of NAM for both unilateral andbilateral clefts is to reduce the severity of the cleftby modifying the position of the alveolar processesand improving the nasal deformity before the pri-mary surgical reconstruction. In unilateral cleft lipand palate (UCLP), the gap between the greater

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and lesser alveolar segments is reduced, the lip el-ements are approximated, the cleft alar base dis-tance is decreased, and the deviated columellais straightened. The collapsed lower lateral alarcartilage on the affected side is elevated andmolded to a more symmetric and convex form.For bilateral cleft lip and palate (BCLP), NAM isable to move the ectopic premaxilla toward themidline and into a less protrusive position. Thecollapsed alveolar segments are expanded, asnecessary. The nasal form is changed throughincreased projection of the nasal tip. The nose ismolded to achieve symmetry and the columellais nonsurgically elongated.

NAM APPLIANCE

The NAM appliance consists of an intraoral acrylicmolding plate and intranasal stents. The moldingplate allows for approximating the greater andlesser alveolar segments in UCLP; in BCLP, thepremaxilla is oriented to the alveolar segments.The nasal stent is made of wire and lined withacrylic. It molds the nasal cartilage on the affectedside in UCLP; in BCLP, there are 2 nasal stents,which insert into both nostrils. The retention but-tons are acrylic attachments on the anterior aspectof the appliance. They allow placement of ortho-dontic elastics attached to Steri-Strips (3M Corpo-ration, St Paul, MN), which function to secure theappliance within the mouth. The typical coursefor NAM treatment entails weekly or biweekly ad-justments of the appliance for 3 to 4 months forUCLP and 4 to 6 months for BCLP.

TREATMENT PLANNING

Because of the variability in presentation of cleft lipand palate, a customized plan is made for eachpatient before beginning molding. It depends onseveral factors, including the type and severity ofthe cleft, age of the infant, and practical consider-ations. The plan should be developed in conjunc-tion with the surgeon and orthodontist andshould involve the cleft team. NAM should ideallybegin as soon after birth as possible to exploitthe plasticity of the nasal cartilage in early infancy.In addition, the infant is more likely to accept theappliance at an earlier age. There is generallyless coordinated hand and finger movement andtherefore minimal ability to remove the tapingand appliance. Regular follow-up is coordinatedwith the team to ensure the infant is feeding andgaining weight appropriately before starting mold-ing and while in treatment.There are occasions when beginning NAM treat-

ment may be delayed or deferred because of a

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unique presentation of the cleft. For instance, thealveolar segments may be severely collapsed inBCLP, resulting in a blocked-out premaxilla. Thiscondition requires expanding the alveolar seg-ments before molding. If the premaxilla is protru-sive, it should be retracted through lip tapingbefore beginning NAM. Another common occur-rence is the presence of a neonatal tooth on thecleft margin. These teeth are typically nonviableand have minimal bone support. These teethshould be extracted and the oral soft tissuesallowed to heal before beginning molding.

Lip Taping

Once a decision has been made to move forwardwith NAM, parents begin lip taping in the timethat elapses between initial presentation andbeginning NAM. It serves multiple roles: (1) it al-lows the infant to become accustomed to theuse of lip tapes; (2) lip taping can serve as an indi-cator of how the baby’s skin will respond to the ad-hesive on the skin (there are instances in which theskin is sensitive and alternative tapes or barriersmay be considered before starting NAM. Thiscan avoid troubleshooting during active NAMtreatment); (3) taping can begin reducing the gapbetween the alveolar segments in the time it takesto begin NAM.Lip taping is common to both UCLP and BCLP.

A base tape made from a hydrocolloid bandage isapplied to the cheeks and maintained for up to1 week. Steri-Strips are then connected with or-thodontic elastic in between them. This tape isthen placed from the noncleft side to the cleftside under tension. For BCLP, 2 elastics areused with a Steri-Strip in between and 2 Steri-Strips on either side. The central tape is positionedover the prolabium and the tapes on the outsideare stretched onto the cheeks.

Impression Technique, Appliance Fabrication,and Design

A maxillary and nasal impression is obtained oncethe infant has been cleared by the medical team toundergo NAM. At minimum, the infant should behealthy and there should be appropriate weightgain. The impression is taken in a clinical settingwith the infant awake. In the event there is anairway emergency, there should be a professionalwho is trained to manage an infant airway.First, an impression tray is selected based on

the size of the maxilla. Heavy-body polysiloxaneputty material (Coltene Rapid soft putty, Coltene,Altstatten, Switzerland) is then loaded into thetray. The swaddled infant is held upside downand the impression tray is seated with positive

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Unilateral and Bilateral Cleft Lip Repair 199

pressure. If the premaxilla is ectopically posi-tioned, it can be moved to the midline just beforeseating the impression tray. Clear visualization ofthe airway is possible by gently pushing the dorsalsurface of the tongue superiorly with a dentalmirror handle. Once the impression material is fullyset, the tray is removed and the oral and nasal cav-ities are confirmed to be free of impression mate-rial. The impression should capture the alveolarsegments including the premaxilla and the vestib-ular anatomy, and should extend posteriorly toinclude the entire alveolus (Fig. 1A,C).

At the same time as the palatal impression, aninitial record of nasal anatomy may be capturedwith an impression of the nose. The impressionis taken with a light-body siloxane material (Mem-osil 2 [polyvinylsiloxane], Heraeus Kulzer, Hanau,Germany). During the impression, the eyes arekept closed and the medial canthi captured toserve as a registration for position of the nose(Fig. 1B,D).

The impressions are poured in dental stone andthe resulting cast is trimmed (Fig. 1A,C). Any un-dercuts are blocked out and the cast coated with

Fig. 1. Oral and nasal models for unilateral (A, B) and bilshould capture the alveolar segments and extend posterof the nasal anatomy may be captured with an impressioeyes closed and the medial canthi captured to serve as re


a separating agent. The appliance is made fromhard, clear, self-cure acrylic that is 2 to 3 mm inthickness. Once set, the frenum attachmentsare relieved and the walls of the appliance aretrimmed to allow 2 mm of space between theappliance and the vestibule. A hole approximately5 mm in diameter is made, centered in the palatalportion of the appliance, to maintain a patentairway should the appliance become dislodgedand block the oral airway. The appliance is nowready for delivery, at which time the retention but-ton will be added.

Appliance Delivery

Delivery is an important time point, because theappliance is adjusted for the infant and the parentsgiven instructions on its use, taping, and care. Theappliance is initially inserted into the mouth and allof the tissues in contact with the acrylic plate arecarefully assessed for possible impingement. Themost frequently observed sites for possible over-extension of the acrylic is in the vestibule ornear the midline and/or lateral frena. If this is the

ateral (C, D) cleft lip and palate. The oral impressionsiorly to include the entire alveolus. An initial recordn of the nose. The impression is completed with thegistration landmarks for the position of the nose.


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case, they are marked and the acrylic subse-quently relieved.Once the molding plate is appropriately relieved

for a passive fit, the retention button is added tothe appliance. For UCLP, the location of the buttonis between the lip elements, favoring the noncleftside and avoiding impingement of the lip. The ratio-nale for this is that the greater segment moves to-ward the lesser segment with molding. For abilateral NAM appliance, the location of the tworetention buttons is one on each side of the distalaspect of the premaxilla and between the lip ele-ments. The length of the button is based on the dis-tance required to clear the lips with the retentiontapes once attached. To maximize retention of theappliance, the button is added at a 30� to 40� angleto the occlusal plane to allow a slight vertical vectorof force to be applied from the tapes.Retention tapes are fabricated from 6 � 100-

mm (0.25 � 4 inch) Steri-Strips and orthodonticelastics (6 mm [0.25 inch] or 5 mm [0.19 inch],128 g [4.5 oz]). They are used from the acrylic plateand adhere to the cheeks, simultaneously securingthe appliance as well as delivering the active forceneeded for correction. For a UCLP, 2 retentiontapes are applied from the single retention button,extending to the left and right cheeks. For a BCLP,1 retention tape is used from each retention but-ton, extending to the left and right cheeks.In order to minimize irritation to the cheeks, a

base tape made from a hydrocolloid bandage isfirst applied to each. They are to be placed justoutside of the nasolabial creases and below theeyes, at an angle, with the medial portion lowerthan the lateral portion. The retention tapes, whichare frequently changed through the course of aday, are then directly adhered to them. The basetapes can be maintained for up to a week.

Nasal Molding

The primary objectives of nasal molding include (1)to increase projection of the nasal tip; (2) to obtainsymmetry of the lower lateral alar cartilages; (3)nonsurgical lengthening of the columella. Nasal


molding is accomplished through use of a singlenasal stent in UCLP and bilateral nasal stents inBCLP (Fig. 2). The nasal stents are added to theappliance once the gap between the alveolar seg-ments is 5 mm or less. This reduction in the dis-tance between the alveolar segments allows forelevation of the cleft alar rim when they are underless tension.The nasal stent consists of 0.91-mm (0.036-

inch) round stainless steel wire; hard, clear, self-cure acrylic; and soft denture liner. The wire isembedded into the appliance using acrylic and isbent to give it an accentuated curve allowing forfuture activations during routine adjustment ap-pointments. The terminal nasal portion is madeup of 2 lobes, a superior and inferior, formedfrom acrylic and covered with soft denture liner.The superior lobe is positioned within the nostrilto project the nasal dome and tip. The inferiorlobe supports the nostril apex. The nasal stent isgradually adjusted to lift, provide support, andmold the cleft nostrils.Unique to a BCLP is the use of the nasal stents to

provide nonsurgical elongation of the columella. Inorder to accomplish this, the nasal stents are con-nected with a band of soft denture liner. This result-ing columella band is positioned at the nasolabialjunction inferiorly and can gradually be increasedin size to elongate the columella. To facilitate thiselongation, an additional Steri-Strip with 2 ortho-dontic elastics can be fabricated and applied fromthe prolabium to the retention buttons.

NASOALVEOLAR MOLDING FOR UNILATERALCLEFT LIP AND PALATE

The goal in molding of the greater and lesser seg-ments in a UCLP is to reduce the space betweenthe 2 segments to 5 mm or less (Fig. 3).Decreasing the width between the greater andlesser alveolar segments facilitates reduction inthe width of the alar base, thereby minimizing thetension in these tissues.Reduction of the width between the 2 segments

is possible through successive removal of acrylic

Fig. 2. NAM devices with nasal mold-ing extensions for unilateral (A) andbilateral (B) cleft lip and palate.


Fig. 3. NAM for unilateral cleft lip and palate. The alveolar gap noted in the initial impression (see Fig. 1A) isnarrowed significantly following NAM (A). The apposition of the alveolar segments, molding of the lowerlateral cartilage, and narrowing of the alar base results in less tension on the tissues and facilitates surgicalrepair (B–G).


within the molding plate along the lesser segmentas selective force is applied through the retentiontapes. To avoid impingement of posterior tissuesas the appliance rotates, acrylic is removed fromthe posterior aspect. Throughout the process, theaddition of soft denture liner can help detail thecorrection within the greater and lesser seg-ments. However, care must be taken to maintainequal removal of acrylic and addition of soft den-ture liner to prevent compression of the alveolarprocess.

The stepwise removal of acrylic with orwithout addition of soft denture liner requiresweekly or biweekly modification of the appli-ance. Each adjustment of the appliance islimited to 1 to 2 mm of addition and/or removalof material, which minimizes the potential fordeveloping any pressure sores or irritations. Inaddition, the appliance tends to be better adapt-ed and more stable with gradual adjustmentsincreasing the infant’s tolerance of the treat-ment. Clinical progress is assessed frequentlyduring the molding process, in anticipation oflip and nasal repair at approximately 6 monthsof age (Fig. 3C–G).


NASOALVEOLAR MOLDING FOR BILATERALCLEFT LIP AND PALATE

Alveolar molding in a BCLP is geared toward posi-tioning the often protrusive and ectopic premaxillabetween the alveolar segments (Fig. 4). This pro-cess requires the premaxilla first to be centeredto the midline before retraction. Similar to the tech-niques used with a UCLP, this is accomplishedthrough sequential removal of acrylic and additionof soft denture liner while applying a selectiveforce with the retention tapes. In situations inwhich the alveolar segments are collapsed pala-tally, they can andmust be expanded through suc-cessive removal of acrylic and addition of dentureliner before retraction of the premaxilla.

As with a UCLP, care must be taken to removeacrylic from the posterior aspect of the applianceduring retraction to avoid impingement of poste-rior tissues. Gradual removal and/or addition ofmaterial is critical to minimize development ofsores and maintain a well-fitting appliancethroughout treatment. Clinical progress isassessed during the molding process, withchanges noted in the premaxillary position, lateral


Fig. 4. NAM for bilateral cleft lip and palate. (A) The collapsed lateral alveolar segments and protrusive premax-illa noted at initial presentation (see Fig. 1C) are corrected following NAM (B). In addition to these changes,molding of the lower lateral cartilages and nonsurgical lengthening of the columella helps improve results in syn-chronous lip-nasal repair (B–G). The clinical examples/figures are the result of careful planning, coordination, andtreatment by the primary orthodontist and senior surgeon (H.K. and R.T.)

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alveolar segments, as well as alar basemorphology and columella. Synchronous lip andnasal repair is performed at approximately6 months of age (see Fig. 4C–G).

QUESTIONS FOR CONSIDERATIONWhat Is the Impact of Nasoalveolar Moldingon Maxillary Growth?

A recent randomized controlled clinical trial evalu-ating the early effects of NAM on maxillary growthin UCLP showed that NAM is effective for realign-ing the greater and lesser segments without imme-diate adverse effects on vertical or transverse archgrowth.1 These findings are consistent with thosereported by Fuchigami and colleagues,11 who,based on a three-dimensional evaluation of dentalcasts in patients with UCLP, showed that NAMimproved maxillary arch morphology and symme-try, as well as nasolabial contour, including colu-mellar positioning.2 NAM was reported to preventalveolar width widening with growth.3 Long-termeffects on maxillary growth remain an area ofactive investigation; such effects may be


confounded by surgical technique for lip and pal-ate repair.

What Are the Outcomes of NasoalveolarMolding?

Outcomes of NAM have been the subject ofseveral recent investigations. Although generaliza-tions about the effectiveness are limited by hetero-geneity between studies, as well as inconsistentfollow-up times, a few trends have been observed.A survey study of surgeons evaluating patientswith cleft lip plus or minus palate suggests thatsurgeons assessed the likelihood of revision tobe less in patients who underwent NAM.1 Broderand colleagues14 report better caregiver-reportedoutcomes following surgery in patients undergoingNAM versus those who had not undergone NAM.2

The difference was most notable with regard tonasal appearance. The observation regardingnasal appearance is consistent with data fromBarillas and colleagues,15 who evaluated nasalmorphology in patients with nonsyndromicUCLP. These investigators retrospectivelyassessed 4 nasal anthropometric distances and



2 angular relationships in patients with UCLP whounderwent NAM compared with patients withUCLP who underwent surgical correction alone.They report a greater degree of nasal symmetryin patients undergoing NAM at an average of9 years postoperatively.3 The same group re-ported improvements in columellar length and adecreased need for nasal surgery at 3 years ofage in patients with BCLP who underwent NAM,compared with those who did not undergoNAM.4 Subsequent work by this group showednearly normal nasal morphology at 12.5 years ofage in patients with BCLP who were treated withNAM and primary nasal reconstruction at thetime of lip repair.5 As with surgical techniques formanagement of cleft lip and palate, there are iden-tifiable differences in outcomes for NAM in UCLPversus BCLP.6 Nostril breadth was more favorablymodified in UCLP, as was bialar width. In BCLP,NAM more effectively increases columellar heightand width.

What Are the Risks of Nasoalveolar Molding?

These purported benefits should be weighedagainst the risks of NAM. A review of NAM-related complications noted that nearly three-quarters of patients had an adverse event relatedto soft tissue, most commonly ulcerations.1

Noncompliance was reported to occur 40% ofthe time. Although these data do not suggestthat NAM is a high-risk undertaking, they dostress the importance of team-based, multidisci-plinary care for patients with cleft-relateddifferences.

SUMMARY

NAM is a powerful presurgical technique used toreduce the severity of the cleft through improvedalignment of the alveolar segments and lip ele-ments. However, its ability to improve on the pri-mary cleft nasal deformity before surgicalcorrection is unique. This improvement includesincreased nasal tip projection, improved symmetryof the lower alar cartilage, and nonsurgical elonga-tion of the columella. Since its introduction, thesingular benefits it offers have been recognizedby numerous practitioners, leading to its adoptionas the treatment of choice at cleft centersthroughout the United States, as well as the restof the world. However, as with choosing any treat-ment modality regarding UCLP and BCLP, carefulconsideration needs to be taken regarding the in-dividuality of every case, with decisions ultimatelybeing made following conscientious discussionsbetween the orthodontist, surgeon, cleft team,and patient.


DISCLOSURE

The authors have nothing to disclose.

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Nasoalveolar Molding for Unilateral and Bilateral Cleft