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Pediatric/Craniofacial: Original Articles

The Nasoalveolar Molding Cleft Protocol: Long-Term Treatment Outcomes from Birth to Facial Maturity

Yarholar, Lauren M. M.D.; Shen, Chen B.S.; Wangsrimongkol, Buddhathida D.D.S, D.M.Sc.; Cutting, Court B. M.D.; Grayson, Barry H. D.D.S.; Staffenberg, David A. M.D.; Shetye, Pradip R. D.D.S.; Flores, Roberto L. M.D.

Author Information
Plastic and Reconstructive Surgery: May 2021 - Volume 147 - Issue 5 - p 787e-794e
doi: 10.1097/PRS.0000000000007828
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Abstract

Cleft lip and palate are the most common congenital anomaly of the face. Although the optimal indications and treatment protocols continue to be debated, one of the most actively discussed therapies is nasoalveolar molding.1–3

Supporters of nasoalveolar molding cite statistically significant improvements in nasal symmetry in patients who undergo the treatment compared with those who do not,4,5 benefit to nasal aesthetics as judged by caregivers and surgeons,6,7 greater benefit to columellar length in patients with bilateral cleft lip,8–10 cost benefit compared with lip adhesion,11 decreased need for revision surgery on the nose,9,12 psychosocial benefit to caregivers,6,7 and the opportunity for primary alveolar reconstruction in the form of gingivoperiosteoplasty, which can avoid secondary alveolar bone grafting procedures in 51 percent to 72 percent of patients.13–16 Furthermore, cleft centers accredited by the American Cleft Palate–Craniofacial Association are utilizing nasoalveolar molding in an increasing trend, with 37 percent of centers using it in 201217 and 43 percent using it in 2019.18

Opponents of nasoalveolar molding report poor caregiver compliance,19,20 limited or no effect of therapy,21,22 disruption of facial growth,23,24 and the lack of high-level supportive scientific evidence.25,26 One of the most significant criticisms of nasoalveolar molding, however, is the lack of reports on its effects at facial maturity, the target assessment timepoint for cleft care interventions.

This study assessed a single institution’s long-term results with nasoalveolar molding by following patients to facial maturity. It evaluated the effects of the nasoalveolar molding protocol on rates of revision surgery to the lip and nose, reviewed the incidence of both secondary alveolar bone grafting and orthognathic surgery, and analyzed the effects on facial growth.

PATIENTS AND METHODS

A single-institution retrospective review was performed of patients with a cleft who completed the nasoalveolar molding protocol to facial maturity, with birth dates ranging from 1990 to 2000. Facial maturity was defined as at least 15 years of age with a wrist radiograph demonstrating closure of the epiphyseal plate. Patients were included in the study if they had a diagnosis of unilateral or bilateral cleft lip and alveolus, with or without cleft palate. Patients were excluded if they had a syndromic diagnosis or if their medical and/or dental records were incomplete.

Patients with a cleft were evaluated within the first 2 weeks after birth by the surgeon and the orthodontist. Nasoalveolar molding, as described by Grayson et al.,27 was initiated over approximately 10 weeks in patients with a unilateral cleft and 20 weeks in patients with a bilateral cleft. Single-stage cleft lip repair and primary cleft rhinoplasty were performed on all patients by the same surgeon (C.B.C.). Patients with a unilateral cleft underwent Cutting’s extended variant28 of the Murawski29,30/Mohler31 cleft lip repair with a modified McComb primary rhinoplasty.28,31–34 Patients with a bilateral cleft underwent single-stage cleft lip repair with retrograde cleft rhinoplasty.35,36 All patients were evaluated for gingivoperiosteoplasty at the time of cleft lip repair, and gingivoperiosteoplasty was performed if the alveolar segments were within 1 to 2 mm of apposition. At approximately 1 year of age, patients underwent single-stage palate repair. Unilateral cleft palate repairs were performed using the Bardach two-flap or von Langenbeck technique at the hard palate, and bilateral cleft palate repairs were performed using the Oxford technique at the hard palate. Soft palate repair was performed using a radical intravelar veloplasty technique.37

Patients were assessed by the same speech-language pathologist at age 18 months, 3 years, 5 years, and 7 years. If velopharyngeal insufficiency was a concern, the patient underwent nasal endoscopic evaluation. The speech-language pathologist independently made recommendations for surgical intervention. All patients who required surgery for velopharyngeal insufficiency underwent a superiorly based pharyngeal flap procedure described by Michael Hogan.38–41 The average age at time of repair was 6 years (range, 2 to 15 years).

The surgeon evaluated patients yearly, and revisions to the lip and nose were performed by request of the family after consultation by the surgeon. Any secondary surgery on the lip and/or nose performed before facial maturity was considered revision surgery.

Maxillary cone-beam computed tomography or dental radiography was performed when the patient reached approximately 8 years of age, to evaluate the need for a secondary alveolar bone graft. If the patient had missing alveolar bone and/or an oronasal fistula in the cleft site that would compromise the long-term stability of adjacent permanent teeth, alveolar bone grafting was recommended. Gingivoperiosteoplasty was considered successful if the alveolar bone present within the cleft site was sufficient to support erupting canine and teeth adjacent to the cleft site. A secondary alveolar bone graft was performed using the Abyholm technique,42 with cancellous bone from the iliac crest.

Orthognathic surgery was performed for moderate and severe skeletal discrepancies. For patients with mild skeletal discrepancy, orthodontic camouflage therapy was performed by compensating the position of the teeth. Options for orthognathic surgery were presented by the orthodontist, and the decision to pursue surgery was made by the patient.

Lateral cephalograms were performed at facial maturity. The anatomical landmarks sella–nasion–point A (SNA), sella-nasion-pogonion (s-n-pg), A point–nasion–B point (ANB), nasion-sella line/nasal line (NSL/NL), nasion-sella line/mandibular line (NSL/ML), nasion-spina nasalis/nasion-gnathion (n-sp/n-gn), axis of upper incisors/nasal line (ILS/NL), and axis of upper incisors/axis of lower incisors (ILS/ILI) were identified and measured using Dolphin Imaging and Management Solutions (version 11; Patterson Dental Supply, Inc., Chatsworth, Calif.). Two orthodontists digitized the cephalometric landmarks separately, and the mean of the two registrations was recorded. Interrater reliability was calculated using the Kappa statistic. We compared our data to the published Eurocleft cephalometric data.43 Statistical analysis was conducted using one-way analysis of variance and the post-hoc Tukey-Kramer method. Alpha (α) was set at 0.05. Statistical analysis was conducted using the R Stats package (version 3.6.1; R Core Team, R Foundation for Statistical Reporting, Vienna, Austria) in RStudio software (version 1.2.1335; RStudio, Boston, Mass.).

RESULTS

A total of 194 patients with a cleft treated with nasoalveolar molding were identified. Eighty-seven patients had not reached facial maturity at the time of their last recorded follow-up visit. One hundred seven patients met the inclusion criteria, 69 with unilateral and 38 with bilateral cleft lip and palate. Eighteen patients included in our study had cleft lip and alveolus and no cleft palate (12 of 69 unilateral patients and six of 38 bilateral patients). The average age at last follow-up visit was 20 years (range, 15 years 4 months to 26 years 10 months).

The patient population included in this study was 57 percent male (61 of 107 patients; unilateral: 61 percent, 42 of 69 patients; bilateral: 50 percent, 19 of 38 patients) and 43 percent female (46 of 107 patients; unilateral: 39 percent, 27 of 69 patients; bilateral: 50 percent, 19 of 38 patients).

Average age at time of unilateral cleft lip repair was 4 months (range, 3 to 7 months), and average age at bilateral cleft lip repair was 6 months (range, 3 to 10 months); average age at unilateral palate repair was 13 months (range, 12 to 16 months), and that at bilateral palate repair was 13 months (range, 11 to 17 months). Gingivoperiosteoplasty was performed in 85 percent of patients (91 of 107 patients; unilateral: 78 percent, 54 of 69 patients; bilateral: 97 percent, 37 of 38 patients). Alveolar bone grafting was performed in 51 percent (55 of 107 patients; unilateral: 54 percent, 37 of 69 patients; bilateral: 47 percent, 18 of 38 patients). Of the patients who underwent gingivoperiosteoplasty, alveolar bone grafting was avoided in 57 percent (52 of 91 patients; unilateral: 59 percent, 32 of 54 patients; bilateral: 54 percent, 20 of 37 patients). Among the patients with a bilateral cleft, 66 alveolar cleft sites underwent gingivoperiosteoplasty and 35 required secondary alveolar bone grafting.

Palatal fistulas were diagnosed in 5 percent (five of 107 patients). Using the Pittsburgh Fistula Classification System,44 all patients had type V fistulas. All patients with a fistula were patients with a bilateral cleft.

Orthognathic surgery was recommended for 53 percent (57 of 107 patients) [45 percent of unilateral patients (31 of 69) and 68 percent of bilateral patients (26 of 38)]. Average age at time of orthognathic surgery was 18 years 3 months. Average distance of maxillary advancement, as measured on postoperative cephalogram, was 7.3 mm (minimum advancement, 4 mm; maximum advancement, 11.5 mm) (unilateral: 7.3 mm; bilateral: 7.3 mm). Six patients who underwent orthognathic surgery (two unilateral and four bilateral) were managed with an intraoral maxillary distraction device (KLS Martin, Jacksonville, Fla.). Average age at time of maxillary distraction was 9 years 11 months (unilateral: 10 years 3 months; bilateral: 14 years 10 months). Six patients who underwent orthognathic surgery (three unilateral and three bilateral) had bimaxillary surgery. Of the patients who were recommended orthognathic surgery, 14 percent (eight of 57 patients) declined the surgery [16 percent unilateral (five of 31) and 12 percent bilateral (three of 26)].

Revisions to the lip, nose, or lip and nose before facial maturity were performed in 12 percent (13 of 107 patients; unilateral: 9 percent, six of 69 patients; bilateral: 18 percent, seven of 38 patients). Forty-six percent (49 of 107 patients) underwent lip and/or nose revision after the age of facial maturity (unilateral: 43 percent, 30 of 69 patients; bilateral: 50 percent, 19 of 38 patients). Nineteen percent (20 of 107 patients) did not require secondary alveolar bone grafting, orthognathic surgery, or a nose or lip revision (unilateral: 20 percent, 14 of 69 patients; bilateral: 16 percent, six of 38 patients). For unilateral cleft lip and palate, the average number of surgical procedures per patient from birth to facial maturity was 3.9 (minimum, two; maximum, seven). For bilateral cleft lip and palate, the average number of surgical procedures was 5.2 (minimum, two; maximum, nine) (Table 1).

Table 1. - Nasoalveolar Molding Protocol Treatment Results
No. of Patients % of Patients Unilateral Bilateral
No. % No. %
Gingivoperiosteoplasty 91 (85) 54 (78) 37 (97)
Alveolar bone grafting 55 (51) 37 (54) 18 (47)
Revision surgery* 55 (51) 34 (49) 21 (55)
Before facial maturity 14 (13) 7 (10) 7 (18)
After facial maturity 50 (46) 31 (44) 19 (50)
Palatal fistula 5 (5) 0 (0) 5 (13)
Orthognathic surgery 49 (46) 26 (38) 23 (61)
No revision surgery, alveolar bone grafting, or orthognathic surgery 20 (19) 14 (20) 6 (16)
*Revision surgery includes revision to lip, nose, or lip and nose.

A total of 37 unilateral cleft lip and palate patients had lateral cephalograms at age 17 years and older that were available for statistical analysis. Three Eurocleft centers were removed from cephalometric analysis to obtain a homogenous sample for comparison. Centers A, B, and F were removed because of late palate closure (centers A and B) and primary alveolar bone grafting (center F) (Table 2).45 Of the remaining Eurocleft centers, center E did not use presurgical orthopedics and was therefore used to assess the effects of nasoalveolar molding on facial growth; center D did use presurgical orthopedics and was therefore used to assess the specific effects of gingivoperiosteoplasty on facial growth. Eighty-four percent of our patients (31 of 37) in the cephalometric analysis had undergone gingivoperiosteoplasty. Results of the cephalometric data analysis are shown in Tables 3 and 4. There was no significant statistical difference in maxillary position (SNA) or facial proportion (n-sp/n-gn) among the patients who underwent nasoalveolar molding with or without gingivoperiosteoplasty compared with Eurocleft centers [nasoalveolar molding versus center E, mean (SD): SNA, 72.7 (5.6) versus 74.9 (3.7) (p = 0.372); s-n-pg, 77.4 (6.0) versus 78.0 (3.6) (p = 0.994); and nasoalveolar molding + gingivoperiosteoplasty versus center D: SNA, 72.1 (5.2) versus 72.9 (4.5) (p = 0.989); s-n-pg, 76.7 (5.7) versus 76.8 (4.4) (p = 0.999)].43

Table 2. - Eurocleft Protocols for the Five Participating Centers*
Eurocleft Center
Age A B D E F
Birth Presurgical orthopedics (Hotz) Presurgical orthopedics (extraoral strapping) Presurgical orthopedics (T-traction)
3 mo Lip closure (Tennison) and vomerplasty Lip closure (Millard) and vomerplasty
3–5 mo Lip closure (Millard, Skoog) Lip closure (various methods and timing)
5 mo Lip closure (modified Skoog, Tennison-Randall) and bone grafting
9–18 mo Soft palate closure (von Langenbeck, Perko, Wardill, Kriens) Palate closure (various methods and timing)
18 mo Palate closure (modified von Langenbeck) Palate closure (Veau-Wardill-Kilner pushback)
24 mo Palate closure (Wardill pushback)
8–11 yr Bone grafting (hard palate closure) Bone grafting Bone grafting Bone grafting
*Reprinted with permission from Semb G, Brattström V, Mølsted K, Prahl-Andersen B, Shaw WC. The Eurocleft study: Intercenter study of treatment outcome in patients with complete cleft lip and palate. Part 1. Introduction and treatment experience. Cleft Palate Craniofac J. 2005;42:64–68.

Table 3. - Cephalometric Analysis, Eurocleft Center D and New York University*
NYU GPP (n = 31) Center D (n = 25) p
SNA 72.1 (5.2) 72.9 (4.5) 0.989
ANB −3.4 (4.3) −2.2 (3.6) 0.769
s-n-pg 76.7 (5.7) 76.8 (4.4) >0.999
NSL/NL 8.7 (4.3) 11.0 (4.5) 0.308
NSL/ML 38.4 (9.2) 37.5 (4.9) 0.997
n-sp/n-gn × 100 42.9 (2.3) 43.2 (2.6) 0.994
ILS/NL 110.5 (7.7) 90.0 (7.1) <0.001
ILS/ILI 130.5 (10.7) 142.5 (8.8) <0.001
NYU, New York University Langone Health; GPP, gingivoperiosteoplasty.
*Data are expressed as mean (SD).

Table 4. - Cephalometric Analysis, Eurocleft Center E and New York University*
NYU (n = 37) Center E (n = 30) p
SNA 72.7 (5.6) 74.9 (3.7) 0.372
ANB −3.5 (4.6) −0.9 (2.2) 0.035
s-n-pg 77.4 (6.0) 78.0 (3.6) 0.994
NSL/NL 8.3 (4.1) 8.0 (3.6) >0.999
NSL/ML 38.3 (8.9) 35.1 (5.5) 0.344
n-sp/n-gn × 100 42.6 (2.5) 41.5 (2.4) 0.450
ILS/NL 110.5 (7.5) 94.2 (6.2) <0.001
ILS/ILI 130.9 (10.1) 136.6 (7.2) 0.198
NYU, New York University Langone Health.
*Data are expressed as mean (SD).

DISCUSSION

This study is the largest, single-institution, long-term analysis of patients with a cleft followed from birth to facial maturity. We demonstrate that nasoalveolar molding did not delay cleft lip and palate reconstruction. Gingivoperiosteoplasty was performed in 85 percent of study patients. Nearly 60 percent of the patients with unilateral cleft and palate who underwent gingivoperiosteoplasty were able to avoid a secondary alveolar bone graft. Previous institutions have reported even higher gingivoperiosteoplasty success rates in unilateral cleft lip and palate of 72 percent.14 Sato et al.15 have shown gingivoperiosteoplasty to be beneficial to most patients, even those who require secondary bone grafting. We believe caution should be exercised in performing gingivoperiosteoplasty, given its high level of technical difficulty. Matic and Power46 have reported very poor results, with injury to adjacent tooth buds. The original motive for gingivoperiosteoplasty was to avoid the morbidity associated with secondary alveolar bone grafting. This morbidity has since been dramatically reduced using trephine techniques47,48; however, gingivoperiosteoplasty can still offer avoidance of additional anesthesia in exchange for additional office visits at infancy. In patients with a bilateral cleft, gingivoperiosteoplasty will affix the premaxilla into an orthotopic position, preventing descent, lockout of the premaxilla, and need for a premaxillary setback. It is notable that premaxillary setback was avoided in all patients in this study. Although the benefits of gingivoperiosteoplasty are still an active area of debate, our cleft center continues to offer this intervention to eligible patients.2,13,15

The cleft nasal deformity can be one of the most challenging aspects of cleft care management. Consistent with previous reports demonstrating the benefit of nasoalveolar molding to nasal symmetry,4 columellar length8–10 and avoidance of revision surgery,9,12 this report demonstrates a low incidence of cleft lip and nasal revision. In patients with a unilateral cleft, 9 percent underwent either a lip, nose, or lip and nose revision before reaching the age of facial maturity. The literature reports that from 30 percent to 80 percent of unilateral cleft lip and palate patients undergo a secondary cleft rhinoplasty before the age of facial maturity.32,33,49,50 Eurocleft did not clarify age at time of surgery, but the series reported rhinoplasty rates as high as 69 percent and lip revision rates of 69 percent.45 The Australian Craniofacial Unit reported a 68 percent rhinoplasty rate for patients with unilateral cleft lip and palate. In addition, the Australian Craniofacial Unit reported that all of their patients had at least one operation for lip and nose revision, which is not uncommon for busy cleft centers.51

The reported soft-tissue revision rates at the time of facial maturity lean toward the lower averaged rates compared with data presented by other institutions with long-term data. Although one may speculate that nasoalveolar molding contributes to the lower rates of nasal revision surgery, its benefit is in controlling the severity of the cleft nasal deformity preoperatively. A recent study demonstrated improved nasal symmetry and aesthetics at facial maturity in patients treated with nasoalveolar molding compared with no nasoalveolar molding.4,52 In further analyses of the patients in our cohort, 68 percent did not require any soft-tissue revision surgery up to the age of facial maturity. In patients with complete cleft lip, nose, alveolus, and palate, the average number of surgical procedures per patient from birth to facial maturity is 4.4 (minimum, two; maximum, nine). For unilateral cleft lip and palate, the average number of surgical procedures per patient is 3.9 (minimum, two; maximum, seven). For bilateral cleft lip and palate, the average number of surgical procedures is 5.2 (minimum, two; maximum, nine). Several studies report patients with a cleft undergoing as many as six procedures per patient for unilateral cleft lip and palate and 10 for bilateral, throughout their treatment course.53 Eliminating additional surgery decreases exposure to anesthesia, provides health care cost savings, and reduces the psychosocial burden for patients and caregivers.

The orthognathic surgery rates presented in this study fall within the ranges reported in the literature, suggesting that nasoalveolar molding does not negatively impact facial growth: 12 percent to 49 percent for unilateral cleft lip and palate and 24 percent to 76 percent for bilateral cleft lip and palate.51,54–65 Indication for orthognathic surgery involves a subjective evaluation that is not standardized between institutions.66 In an attempt to avoid the bias of subjectivity in orthognathic surgery rates, we used cephalometric data to analyze facial growth. A cohort of patients with unilateral cleft lip and palate were compared to Eurocleft data. The Eurocleft series only included data for patients with a unilateral cleft lip and palate; therefore, a comparative analysis for bilateral cleft lip and palate could not be performed. Comparative analysis of SNA did not reveal statistically significant differences between nasoalveolar molding–treated patients (with or without gingivoperiosteoplasty) compared to Eurocleft. There was a significant difference in ANB between nasoalveolar molding–treated patients and Eurocleft center E, suggesting that there could be a trend to maxillary deficiency that could be detected in a larger study. It is notable that this is the largest single-center study of a cleft treatment protocol from birth to facial maturity. There was no statistical difference between SNB and facial proportion in the vertical dimension (n-sp/n-gn) (Tables 3 and 4).

Although these data suggest that the nasoalveolar molding protocol does not inhibit midface growth, the most supportive data to the benefit of nasoalveolar molding are in the avoidance of revision and secondary surgery. In addition to avoidance of alveolar bone grafting in 57 percent of patients who underwent gingivoperiosteoplasty and avoidance of any revision surgery to the lip and nose before facial maturity in 68 percent of patients, 19 percent of our patient cohort (20 of 107 patients) did not need revision surgery, secondary alveolar bone grafting, or orthognathic surgery.

We present the first comprehensive analysis of patients undergoing the nasoalveolar molding treatment protocol from birth to facial maturity. All patients underwent evaluation and management by a single orthodontist, surgeon, and speech pathologist, contributing to the consistency of the treatment and assessment. The Slavcleft group published retrospective results from a three-center study evaluating cephalometric and dental arch data in unilateral cleft lip and palate patients; however, average reported age at time of evaluation was 10 to 11 years, and variables were limited.67,68 The Eurocleft studies report on unilateral cleft lip and palate patients with multiple variables, and their patients are followed to facial maturity; however, their studies have been limited to include patients with a unilateral cleft only. The size of their cohort was also limited, with the five centers reporting 23, 26, 25, 30, and 20 patients each.43,45,61,69,70 The Australian Craniofacial Unit has multiple series describing their protocol for treatment of craniofacial patients, including articles dedicated to unilateral and bilateral cleft lip and palate. Patients have completed treatment and were followed from birth to facial maturity; however, the size of the patient cohort was also limited, with 22 patients meeting inclusion criteria for unilateral cleft lip and palate and 19 for bilateral cleft lip and palate.51,57

The present study does have limitations. Patients were included only if they had completed nasoalveolar molding treatment, and all patients who did not complete the treatment were removed. Although this number of patients was a minority, their elimination could have affected the reported results. In addition, the reported outcomes are a result of multiple variables, including quality of surgical, dental, speech, psychosocial, and nursing care, which was not accounted for in this study. This study did not have a formal comparison group. Rather, our results were compared with those of a number of previously published studies in which the two study groups may not have been appropriately matched. There were no reports on aesthetic outcomes in this study. Although aesthetic analysis was not an endpoint of this study, we have previously reported on nasal aesthetics demonstrating the benefit of nasoalveolar molding at the time of facial maturity.71

CONCLUSIONS

Nasoalveolar molding can limit the rate of lip and nose revision and secondary alveolar bone grafting when combined with gingivoperiosteoplasty. This study suggests that the nasoalveolar molding protocol, when performed alone or with gingivoperiosteoplasty, may not negatively impact facial growth in patients with a unilateral cleft lip and palate.

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