Medscape is available in 5 Language Editions – Choose your Edition here.


Presurgical Orthopedic Therapy for Cleft Lip and Palate

  • Author: Donald R Laub, Jr, MD, MS, FACS; Chief Editor: Arlen D Meyers, MD, MBA  more...
Updated: Apr 01, 2015



In presurgical orthopedic therapy, orthodontic techniques are used to mold the maxillary, alveolar, and nasal tissues of an infant with a unilateral or bilateral cleft lip and palate. Other terms used for these techniques are neonatal infant orthopedics, presurgical infant orthopedics, and nasal-alveolar molding.[1] Because the infant does not yet have teeth, the term orthodontics would be inaccurate; thus, orthopedics is the preferred term.

The use of presurgical orthopedic therapy is widespread; 47-51% of neonates treated for cleft lip and palate in the United Kingdom have presurgical appliances.[2] In the United States and Canada, 71% of centers reported using some form of presurgical molding before bilateral cleft lip surgery, with nasoalveolar molding being the most popular at 55% of those using this treatment.[3]

Two categories of appliances are used: passive and active. Active appliances are fixed intraorally and apply traction through mechanical means such as elastic chains, screws, and plates.[4, 5] Passive appliances maintain the distance between the 2 maxillary segments while external force is applied to the primarily to reposition it posteriorly. The nasoalveolar molding device (see the image below) is a very elaborate passive device; it consists of an intraoral acrylic plate held in place with extraoral elastics and tape. In later phases of treatment, wire outriggers are added that apply protracting force to the vestibule of the nares, lengthening the columella.[6]

A nasoalveolar molding device. A nasoalveolar molding device.

External force can be applied by external taping of the lip, a head cap with elastic straps across the prolabium, or a surgical lip adhesion.[6] See the image below.

A child with unilateral cleft lip and palate being A child with unilateral cleft lip and palate being treated with tape adhesion.

Presurgical orthopedic devices are a controversial topic in cleft treatment. Arguments against their use include the potential for long-term growth effects and potential feeding difficulty.[7, 8] With increasing clinical experience, the long-term outcome and the specific role of presurgical orthopedics are becoming better defined.[9, 10, 11, 12, 13] Empirically, molding can narrow the width of clefts and make subsequent surgery less technically demanding. The long-term outcomes of individuals treated with this protocol will determine its future acceptance.


Indications for the use of presurgical orthopedic therapy are evolving. Advantages include the following:

  • Improvement in soft tissue form, reducing the need for surgical dissection [14, 15]
  • The ability to perform either primary bone grafting or gingivoperiosteoplasty, which could potentially reduce the need for secondary bone grafts [16, 17, 18]
  • The potential for improved feeding efficiency owing to cleft narrowing and obturation; Masarei et al, however, found that presurgical orthopedic therapy did not improve feeding efficiency in treated infants [19]


Contraindications include a lack of family and patient compliance or acceptance of the device.


Several large case control studies have demonstrated adverse outcomes in protocols using active presurgical orthopedic therapy. Henkeland and Gundlach reported that the Latham-Millard active orthopedic device had an adverse effect on facial growth.[20] Berkowitz reported worsened occlusal outcomes in the patients treated with the Latham-Millard device.[21] Matic and Power found maxillary growth to be decreased after active presurgical orthopedic therapy in unilateral and bilateral clefts, respectively.[22, 23] They also found that almost all patients treated with gingivoperiosteoplasty or primary bone graft also required secondary bone grafting.

Studies of passive-treatment presurgical orthopedic therapy have shown a more mixed outcome. Wood et al reported that the passive nasoalveolar molding device and primary gingivoperiosteoplasty did not cause an unfavorable effect on facial growth.[24] For patients treated with a nasoalveolar molding device and a primary gingivoperiosteoplasty, Santiago et al reported a reduced need for secondary alveolar bone grafts.[25] Shetty et al, however, found better outcomes in patients on whom the nasoalveolar molding treatment had begun within 1 year of life, as opposed to those in whom treatment began later.[26]

Preoperative treatment with nasoalveolar molding seems to improve results of nasal shape, especially in bilateral clefts. Garfinkle et al presented a series of patients with bilateral cleft lip and palate treated with a nasoalveolar molding protocol who required no further intervention for nasal reconstruction beyond their initial repair.[27] Nazrian-Mobin et al found that nasoalveolar molding improved the nasal columnar length and width much better in patients with bilateral clefts than in those with unilateral clefts.[28]

Bongaarts et al reported on results from the multicenter Dutch cleft experience; they found that presurgical orthopedic therapy with a passive acrylic plate similar to the nasoalveolar molding system showed no improvement in occlusal outcomes.[29] Uzel and Alparslan published a meta-analysis of 8 randomized controlled trials and 4 case-controlled trials with presurgical orthopedic therapy appliances; they found no long-term positive effects on the studied treatment outcomes in patients with cleft lip and palate.[30] Van der Heijden et al in a meta-analysis of 12 studies of presurgical orthopedic treatment of unilateral cleft lip found inconsistent results on nasal symmetry.[31] Both authors of the meta-analyses concluded that studies were heterogeneous and more randomized controlled trials are needed to evaluate the effects of different surgical protocols.

Relevant Anatomy

The lips surround the entrance to the oral cavity. The upper lip extends from the base of the nose superiorly to the nasolabial folds laterally and to the free edge of the vermilion border inferiorly. The lower lip extends from the superior free vermilion edge superiorly, to the commissures laterally, and to the mandible inferiorly. Around the circumferential vermilion-skin border, a fine line of pale skin accentuates the color difference between the vermilion and normal skin. Along the upper vermilion-skin border, 2 paramedian elevations of the vermilion form the Cupid bow. Two raised vertical columns of tissue form a midline depression called the philtrum. The philtrum is located between the paramedian elevations of the vermilion and the columella above.

The oropharynx is the middle part of the pharynx directly below the soft palate that communicates anteriorly with the oral cavity proper by the isthmus of the fauces, also known as the oropharyngeal isthmus. Specifically, the oropharyngeal isthmus is bound superiorly by the soft palate, laterally by the palatoglossal arches, and inferiorly by the posterior third of the tongue. The most prominent feature of the oropharynx is the two folds that are termed the pillars of the fauces, the palatoglossal arch and the palatopharyngeal arch. The palatoglossal arch contains the palatoglossus muscle and travels anteroinferiorly from the soft palate to the lateral aspect of the tongue.

For more information about the relevant anatomy, see Lips and Perioral Region Anatomy and Pharynx Anatomy. Also see Nasal Anatomy, Mouth Anatomy, and Facial Bone Anatomy.


Periprocedural Care

Pre-Procedure Planning

Children with cleft deformities require a multidisciplinary approach to reconstruction. A team approach to treatment is the standard of care. Close cooperation of the surgeon with the orthodontist is necessary to achieve desirable outcomes with presurgical orthopedic therapy.


The major controversies in the use of presurgical orthopedic therapy are the potential for primary bone grafting or gingivoperiosteoplasty to cause the following:

  • Growth retardation and subsequent maxillary retrusion
  • Worsened occlusal relationships

Complications related to the specific devices include the following:

  • Feeding difficulties
  • Skin irritation from tape
  • Pressure ulceration of the gingival mucosa
  • Possible of airway obstruction from a misplaced intraoral device


Presurgical Phase

The presurgical phase involves the application of the device, activation of forces, and treatment adjustments.

In passive appliance protocols, deformational forces are transmitted through soft tissue. Tape adhesion may be used as an initial or as a complete treatment. Tape is applied to the infant's cheeks with some traction directed toward closing the cleft gap. A base layer of tape may be used on the cheeks in order to prevent traction blisters. Tapes are replaced by parents daily or more often, keeping a constant deformational force closing the cleft gap.

In the nasoalveolar molding ( NAM) protocol, an acrylic plate is placed intraorally to effect alveolar and nasal molding. In order to fashion the plate, a maxillary impression must be made. This can be performed in the office or in a procedure room if proper equipment is available to safeguard the infant's airway. Once the intraoral plate is fashioned, it is stabilized in the infant's mouth with tapes or elastics secured to base tapes on the child's cheeks, similar to those used in tape adhesion technique. The acrylic plate is adjusted in the orthodontic clinic on a weekly basis, with acrylic added in areas to create pressure on the tissue and removed in areas where the tissue is expected move. Choo et al presented a modification for treatment of bilateral cleft in which the premaxilla was excluded from the plate and the lateral segments alone were treated.[32]

In active appliance protocols, such as that of Latham, the deformational forces are transmitted directly to bone via trans-mucosal pins. As such, the appliance must be secured in the operating room. Once placed, adjustments are made by turning a traction screw on the appliance.

Cleft Lip Repair

Surgical cleft lip repair reestablishes the soft tissue and muscular forces on the easily moldable maxillary arch segments. Two categories of appliances are used, passive and active.

Passive appliances maintain the distance between the 2 maxillary segments while external force is applied to encourage posterior repositioning. This external force can be external taping, a head cap with elastic straps across the prolabium, or even a surgical lip adhesion. See the image below.

A child with bilateral cleft lip and palate being A child with bilateral cleft lip and palate being treated with a nasoalveolar molding device.

Active appliances are fixed intraorally and apply traction through mechanical means such as elastic chains, screws, and plates.

For bilateral clefts, external pressure is often used to help maintain the premaxillary component within the arch alignment. Soft elastic tape across the premaxilla, a head cap with elastic traction, or lip adhesion have been used prior to a definitive lip repair once the arch segments have approximated. See the images below.

A child with bilateral cleft lip and palate being A child with bilateral cleft lip and palate being treated with tape adhesion prior to beginning nasoalveolar molding therapy.
The same child being treated with a nasoalveolar m The same child being treated with a nasoalveolar molding device after tape adhesion.

Cleft Nasal Repair

The palatal appliance may be modified to include a nasal extension to help improve the nasal tip form.

Operative Phase

Surgeons must alter their surgical techniques to optimize the advantages offered by presurgical orthopedic therapy. Details are provided in Bilateral Cleft Lip Repair and Bilateral Cleft Nasal Repair.

When presurgical orthopedic therapy is used to convert a wide cleft into a narrower one, less dissection and hence less surgical trauma will be necessary. More controversially, there is potential with the narrower cleft to perform primary bone graft or a gingivoperiosteoplasty.

Contributor Information and Disclosures

Donald R Laub, Jr, MD, MS, FACS Professor, Departments of Surgery and Pediatrics, University of Vermont College of Medicine; Medical Director, Vermont State Cleft Palate-Craniofacial Center; Medical Director, Children's Upper Extremity Center at Fletcher-Allen Health Care

Donald R Laub, Jr, MD, MS, FACS is a member of the following medical societies: Alpha Omega Alpha, American Association for Hand Surgery, American Cleft Palate-Craniofacial Association, American College of Surgeons, American Society for Surgery of the Hand, American Society of Maxillofacial Surgeons, American Society of Plastic Surgeons, Association for Academic Surgery, Vermont Medical Society, AO Foundation, American Association of Pediatric Plastic Surgeons, Northeastern Society of Plastic Surgeons

Disclosure: Nothing to disclose.


Barrett G Peterson, DMD Orthodontist, Champlain Orthodontic Associates; Orthodontist, Cleft Lip and Palate Team, Fletcher Allen Health Care

Barrett G Peterson, DMD is a member of the following medical societies: American Dental Association, American Association of Orthodontists, Vermont State Dental Society

Disclosure: Nothing to disclose.

Chief Editor

Arlen D Meyers, MD, MBA Professor of Otolaryngology, Dentistry, and Engineering, University of Colorado School of Medicine

Arlen D Meyers, MD, MBA is a member of the following medical societies: American Academy of Facial Plastic and Reconstructive Surgery, American Academy of Otolaryngology-Head and Neck Surgery, American Head and Neck Society

Disclosure: Serve(d) as a director, officer, partner, employee, advisor, consultant or trustee for: Cerescan;RxRevu;SymbiaAllergySolutions<br/>Received income in an amount equal to or greater than $250 from: Symbia<br/>Received from Allergy Solutions, Inc for board membership; Received honoraria from RxRevu for chief medical editor; Received salary from Medvoy for founder and president; Received consulting fee from Corvectra for senior medical advisor; Received ownership interest from Cerescan for consulting; Received consulting fee from Essiahealth for advisor; Received consulting fee from Carespan for advisor; Received consulting fee from Covidien for consulting.

  1. Mazaheri M, Brecht LE. Presurgical Orthopedics. Losee JE, Kirschner RE. Comprehensive Cleft Care. New York: McGraw Hill; 2008. Ch. 45, pp. 693-700.

  2. Sandy J, Williams A, Mildinhall S, et al. The Clinical Standards Advisory Group (CSAG) Cleft Lip and Palate Study. Br J Orthod. 1998 Feb. 25(1):21-30. [Medline].

  3. Tan SP, Greene AK, Mulliken JB. Current surgical management of bilateral cleft lip in North America. Plast Reconstr Surg. 2012 Jun. 129(6):1347-55. [Medline].

  4. Millard DR, Latham R, Huifen X, Spiro S, Morovic C. Cleft lip and palate treated by presurgical orthopedics, gingivoperiosteoplasty, and lip adhesion (POPLA) compared with previous lip adhesion method: a preliminary study of serial dental casts. Plast Reconstr Surg. 1999 May. 103(6):1630-44. [Medline].

  5. Moore CC, MacDonald I, Latham R, Brandt MG. Septopalatal protraction for correction of nasal septal deformity in cleft palate infants. Otolaryngol Head Neck Surg. 2005 Dec. 133(6):949-53. [Medline].

  6. Grayson BH, Garfinkle JS. Nasoalveolar Molding and Columella Elongation in Preperation for the Primary Repair of Unilateral and Bilateral Cleft Lip and Palate. Losee JE, Kirschner RE. Comprehensive Cleft Care. New York: McGraw Hill; 2008. Ch. 46, pp. 701-720.

  7. Lee CT, Grayson BH, Cutting CB, Brecht LE, Lin WY. Prepubertal midface growth in unilateral cleft lip and palate following alveolar molding and gingivoperiosteoplasty. Cleft Palate Craniofac J. 2004 Jul. 41(4):375-80. [Medline].

  8. Levitt T, Long RE Jr, Trotman CA. Maxillary growth in patients with clefts following secondary alveolar bone grafting. Cleft Palate Craniofac J. 1999 Sep. 36(5):398-406. [Medline].

  9. Aminpour S, Tollefson TT. Recent advances in presurgical molding in cleft lip and palate. Curr Opin Otolaryngol Head Neck Surg. 2008 Aug. 16(4):339-46. [Medline].

  10. Shetye PR. Presurgical infant orthopedics. J Craniofac Surg. 2012 Jan. 23(1):210-1. [Medline].

  11. Rau A, Ritschl LM, Mücke T, Wolff KD, Loeffelbein DJ. Nasoalveolar molding in cleft care-experience in 40 patients from a single centre in Germany. PLoS One. 2015. 10(3):e0118103. [Medline]. [Full Text].

  12. Mandwe RS, Puri S, Shingane S, Pawar G, Kolhe VR, Alsi A. Presurgical nasoalveolar remodeling - an experience in the journey of cleft lip and palate. Clin Cosmet Investig Dent. 2015. 7:1-7. [Medline]. [Full Text].

  13. Rubin MS, Clouston S, Ahmed MM, M Lowe K, Shetye PR, Broder HL, et al. Assessment of presurgical clefts and predicted surgical outcome in patients treated with and without nasoalveolar molding. J Craniofac Surg. 2015 Jan. 26(1):71-5. [Medline]. [Full Text].

  14. Rosenstein SW, Grasseschi M, Dado DV. A long-term retrospective outcome assessment of facial growth, secondary surgical need, and maxillary lateral incisor status in a surgical-orthodontic protocol for complete clefts. Plast Reconstr Surg. 2003 Jan. 111(1):1-13; discussion 14-6. [Medline].

  15. Trotman CA, Long RE Jr, Rosenstein SW, Murphy C, Johnston LE Jr. Comparison of facial form in primary alveolar bone-grafted and nongrafted unilateral cleft lip and palate patients: intercenter retrospective study. Cleft Palate Craniofac J. 1996 Mar. 33(2):91-5. [Medline].

  16. Power SM, Matic DB. Gingivoperiosteoplasty following alveolar molding with a Latham appliance versus secondary bone grafting: the effects on bone production and midfacial growth in patients with bilateral clefts. Plast Reconstr Surg. 2009 Aug. 124(2):573-82. [Medline].

  17. Pfeifer TM, Grayson BH, Cutting CB. Nasoalveolar molding and gingivoperiosteoplasty versus alveolar bone graft: an outcome analysis of costs in the treatment of unilateral cleft alveolus. Cleft Palate Craniofac J. 2002 Jan. 39(1):26-9. [Medline].

  18. Sato Y, Grayson BH, Garfinkle JS, Barillas I, Maki K, Cutting CB. Success rate of gingivoperiosteoplasty with and without secondary bone grafts compared with secondary alveolar bone grafts alone. Plast Reconstr Surg. 2008 Apr. 121(4):1356-67; discussion 1368-9. [Medline].

  19. Masarei AG, Wade A, Mars M, Sommerlad BC, Sell D. A randomized control trial investigating the effect of presurgical orthopedics on feeding in infants with cleft lip and/or palate. Cleft Palate Craniofac J. 2007 Mar. 44(2):182-93. [Medline].

  20. Henkel KO, Gundlach KK. Analysis of primary gingivoperiosteoplasty in alveolar cleft repair. Part I: Facial growth. J Craniomaxillofac Surg. 1997 Oct. 25(5):266-9. [Medline].

  21. Berkowitz S, Mejia M, Bystrik A. A comparison of the effects of the Latham-Millard procedure with those of a conservative treatment approach for dental occlusion and facial aesthetics in unilateral and bilateral complete cleft lip and palate: part I. Dental occlusion. Plast Reconstr Surg. 2004 Jan. 113(1):1-18. [Medline].

  22. Matic DB, Power SM. The effects of gingivoperiosteoplasty following alveolar molding with a pin-retained Latham appliance versus secondary bone grafting on midfacial growth in patients with unilateral clefts. Plast Reconstr Surg. 2008 Sep. 122(3):863-70; discussion 871-3. [Medline].

  23. Matic DB, Power SM. Evaluating the success of gingivoperiosteoplasty versus secondary bone grafting in patients with unilateral clefts. Plast Reconstr Surg. 2008 Apr. 121(4):1343-53; discussion 1368-9. [Medline].

  24. Wood RJ, Grayson BH, Cutting CB. Gingivoperiosteoplasty and midfacial growth. Cleft Palate Craniofac J. 1997 Jan. 34(1):17-20. [Medline].

  25. Santiago PE, Grayson BH, Cutting CB, Gianoutsos MP, Brecht LE, Kwon SM. Reduced need for alveolar bone grafting by presurgical orthopedics and primary gingivoperiosteoplasty. Cleft Palate Craniofac J. 1998 Jan. 35(1):77-80. [Medline].

  26. Shetty V, Vyas HJ, Sharma SM, Sailer HF. A comparison of results using nasoalveolar moulding in cleft infants treated within 1 month of life versus those treated after this period: development of a new protocol. Int J Oral Maxillofac Surg. 2012 Jan. 41(1):28-36. [Medline].

  27. Garfinkle JS, King TW, Grayson BH, Brecht LE, Cutting CB. A 12-year anthropometric evaluation of the nose in bilateral cleft lip-cleft palate patients following nasoalveolar molding and cutting bilateral cleft lip and nose reconstruction. Plast Reconstr Surg. 2011 Apr. 127(4):1659-67. [Medline].

  28. Nazarian Mobin SS, Karatsonyi A, Vidar EN, Gamer S, Groper J, Hammoudeh JA. Is presurgical nasoalveolar molding therapy more effective in unilateral or bilateral cleft lip-cleft palate patients?. Plast Reconstr Surg. 2011 Mar. 127(3):1263-9. [Medline].

  29. Bongaarts CA, van't Hof MA, Prahl-Andersen B, Dirks IV, Kuijpers-Jagtman AM. Infant orthopedics has no effect on maxillary arch dimensions in the deciduous dentition of children with complete unilateral cleft lip and palate (Dutchcleft). Cleft Palate Craniofac J. 2006 Nov. 43(6):665-72. [Medline].

  30. Uzel A, Alparslan N. Long-term Effects of Presurgical Infant Orthopedics in Patients with Cleft Lip and Palate: A Systematic Review. Cleft Palate Craniofac J. 2010 Sep 17. [Medline].

  31. van der Heijden P, Dijkstra PU, Stellingsma C, van der Laan BF, Korsten-Meijer AG, Goorhuis-Brouwer SM. Limited evidence for the effect of presurgical nasoalveolar molding in unilateral cleft on nasal symmetry: a call for unified research. Plast Reconstr Surg. 2013 Jan. 131(1):62e-71e. [Medline].

  32. Choo H, Maguire M, Low DW. Modified technique of presurgical infant maxillary orthopedics for complete bilateral cleft lip and palate. Plast Reconstr Surg. 2012 Jan. 129(1):244-8. [Medline].

A nasoalveolar molding device.
A child with bilateral cleft lip and palate being treated with a nasoalveolar molding device.
A child with unilateral cleft lip and palate being treated with tape adhesion.
A child with bilateral cleft lip and palate being treated with tape adhesion prior to beginning nasoalveolar molding therapy.
The same child being treated with a nasoalveolar molding device after tape adhesion.
All material on this website is protected by copyright, Copyright © 1994-2016 by WebMD LLC. This website also contains material copyrighted by 3rd parties.