Judah S. Garfinkle

Nasoalveolar molding improves appearance of children with bilateral cleft lip-cleft palate.

Background: Bilateral cleft lip–cleft palate is associated with nasal deformities typified by a short columella. The authors compared nasal outcomes of cleft patients treated with banked fork flaps to those of patients who underwent nasoalveolar molding and primary retrograde nasal reconstruction. Methods: A retrospective review of 26 consecutive patients with bilateral cleft lip–cleft palate was performed. Group 1 patients (n = 13) had a cleft lip repair and nasal correction with banked fork flaps. Group 2 patients (n = 13) had nonsurgical columellar elongation with nasoalveolar molding followed by cleft lip closure and primary retrograde nasal correction. Group 3 patients (n = 13) were age-matched controls. Columellar length was measured at presentation and at 3 years of age. The number of nasal operations was recorded to 9 years. The Kruskal-Wallis and Tukey-Kramer tests were used for statistical analysis. Results: Initial columellar length was 0.49 ± 0.37 mm in group 1 and 0.42 ± 0.62 mm in group 2. Post–nasoalveolar molding columellar length was 4.5 ± 0.76 mm in group 2. By 3 years of age, columellar length was 3.03 ± 1.47 mm in group 1, 5.98 ± 1.09 mm in group 2, and 6.35 ± 0.99 mm in group 3. Group 2 columellar length was significantly greater (p < 0.001) than that of group 1 and not statistically different from that of group 3 (p > 0.05). All group 1 patients (13 of 13) needed secondary nasal surgery. No nasoalveolar molding patients (zero of 13, group 2) required secondary nasal surgery. Conclusion: Nonsurgical columellar elongation with nasoalveolar molding followed by primary retrograde nasal reconstruction restored columellar length to normal by 3 years and significantly reduced the need for secondary nasal surgery.

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

Background: Patients with bilateral cleft lip–cleft palate have nasal deformities including reduced nasal tip projection, widened ala base, and a deficient or absent columella. The authors compare the nasal morphology of patients treated with presurgical nasoalveolar molding followed by primary lip/nasal reconstruction with age-matched noncleft controls. Methods: A longitudinal, retrospective review of 77 nonsyndromic patients with bilateral cleft lip–cleft palate was performed. Nasal tip protrusion, alar base width, alar width, columella length, and columella width were measured at five time points spanning 12.5 years. A one-sample t test was used for statistical comparison to an age-matched noncleft population published by Farkas. Results: All five measurements demonstrated parallel, proportional growth in the treatment group relative to the noncleft group. The nasal tip protrusion, alar base width, alar width, columella length, and columella width were not statistically different from those of the noncleft, age-matched control group at age 12.5 years. The nasal tip protrusion also showed no difference in length at 7 and 12.5 years. The alar width and alar base width were significantly wider at the first four time points. Conclusions: This is the first study to describe nasal morphology following nasoalveolar molding and primary surgical repair in patients with bilateral cleft lip–cleft palate through the age of 12.5 years. In this investigation, the authors have shown that patients with bilateral cleft lip–cleft palate treated at their institution with nasoalveolar molding and primary nasal reconstruction, performed at the time of their lip repair, attained nearly normal nasal morphology through 12.5 years of age.

Success rate of gingivoperiosteoplasty with and without secondary bone grafts compared with secondary alveolar bone grafts alone.

Background: Gingivoperiosteoplasty has been shown to eliminate the need for secondary alveolar bone grafting in 60 percent of patients. The purpose of this study was to compare radiographic alveolar anatomy following infant gingivoperiosteoplasty, secondary alveolar bone grafting, and secondary alveolar bone grafting in patients who had prior infant gingivoperiosteoplasty with inadequate bone formation. Methods: Seventy-four consecutive nonsyndromic patients (complete bilateral cleft lip–cleft palate, n = 12; complete unilateral cleft lip–cleft palate, n = 46; complete unilateral cleft lip and alveolus, n = 14) treated at New York University Medical Center were available for evaluation. Eighty-two complete alveolar cleft sites were assigned to three groups: gingivoperiosteoplasty (n = 30), secondary alveolar bone grafting (n = 41), and secondary alveolar bone grafting following gingivoperiosteoplasty (n = 11). All gingivoperiosteoplasties were performed at the time of primary lip surgery, and secondary alveolar bone grafting (cancellous iliac crest at 7 to 12.5 years of age) was performed before eruption of the permanent canine. Radiographs were measured according to the modified method of Long. Results: Seventy-three percent of gingivoperiosteoplasty cases did not require secondary alveolar bone grafting and none had fistulas. The rate of missing teeth in the total sample, adjacent to the cleft, was within normal limits for the population. Group 1 alone and groups 1 and 3 combined had superior alveolar anatomy compared with group 2 (p < 0.01). No significant differences existed between groups 1 and 3 (p > 0.05). Crest height was best in group 1 (p < 0.01), followed by group 3 and then group 2, with no difference between the latter two groups. Conclusion: Gingivoperiosteoplasty alone or combined with secondary alveolar bone grafting results in superior bone levels when compared with conventional secondary alveolar bone grafting alone.

Documentation of the incidents associated with mandibular distraction: introduction of a new stratification system.

Background: This article aims to assess the spectrum of unfavorable events or incidents encountered during mandibular distraction and to evaluate the difference in the incident rates among the following treatment groups: (1) native bone distraction using an external device, (2) native bone distraction using an internal device, and (3) grafted bone distraction using an external device. Methods: This retrospective study examined the records of 141 patients treated by mandibular distraction over a 16-year period. Of the total 141 patients, 56 underwent unilateral mandibular distraction and 85 underwent bilateral mandibular distraction, contributing to a total of 226 sided distraction procedures. The number of procedures performed on native bone using external devices was 149, versus 41 internal devices. There were 36 distractions performed on grafted bone with external devices. Incidents were broadly classified into three groups based on a severity index. A minor incident was one that resolved satisfactorily with minimal or no invasive intervention. A moderate incident was one that resolved satisfactorily with moderate clinical intervention. A major incident was one that did not resolve or could not be resolved with surgical intervention, and compromised treatment outcome. Results: The major incident rate was 5.31 percent (total of 226 distraction procedures). A higher rate of major incidents was observed when distracting grafted bone. The overall minor incident rate was 26.99 percent and the moderate incident rate was 20.35 percent. Conclusion: Mandibular distraction can be considered a safe and predictable procedure for lengthening/augmenting the mandible in patients with lower jaw deficiencies.

The importance of vector selection in preoperative planning of unilateral mandibular distraction.

Background: Unilateral craniofacial microsomia is characterized by soft-tissue and bony deficiencies. Mandibular distraction osteogenesis can be used to augment the hypoplastic skeleton and improve facial symmetry. The aim of this study was to determine how the vector of unilateral mandibular distraction affects treatment outcomes. Methods: A retrospective chart and radiographic review was conducted of all patients treated with external mandibular distraction osteogenesis between October of 1990 and February of 2004 (n = 185). A subset of 42 patients underwent primary unilateral, uniplanar, external distraction, and 13 patients were found to have satisfied inclusion criteria and had adequate predistraction and postdistraction lateral and posteroanterior cephalograms. Cephalometric tracings were made and multiple points and planes were assessed before and after distraction. Results: A strong correlation was noted between the vector of distraction and the movement of the mandible. A horizontal vector of distraction resulted in minimal increase in ramal length but a marked shift in the mandibular midline (r = 0.68, p < 0.05). In contrast, a vertical vector of distraction resulted in marked mandibular ramus lengthening but minimal mandibular midline shift (r = 0.73, p < 0.05). Mathematical formulas were derived to correlate the distraction vector and mandibular movements to improve preoperative planning. Conclusions: Successful distraction is dependent on accurate preoperative planning and prediction of outcomes. This study demonstrates a predictable relationship between the vector of unilateral distraction and the mandibular response.

Early cleft management: The case for nasoalveolar molding

1 The aim of this Point/Counterpoint article is to discuss the value of nasoalveolar molding (NAM) therapy as part of the treatment protocol for infants born with cleft lip and palate. To better understand the debate over NAM and the valuable impact it can have in the management of an infant born with a cleft, the psychosocial, anatomic, and surgical challenges associated with clefts will be reviewed. A comparison of NAM to previous presurgical infant orthopedic techniques will then be presented. An appraisal of the NAM literature will be offered.

Surgeon's and Caregivers' Appraisals of Primary Cleft Lip Treatment with and without Nasoalveolar Molding: A Prospective Multicenter Pilot Study

Background: Despite the increasing use of nasoalveolar molding in early cleft treatment, questions remain about its effectiveness. This study examines clinician and caregiver appraisals of primary cleft lip and nasal reconstruction with and without nasoalveolar molding in a nonrandomized, prospective, multicenter study. Methods: Participants were 110 infants with cleft lip/palate (62 treated with and 48 treated without nasoalveolar molding) and their caregivers seeking treatment at one of six high-volume cleft centers. Using the Extent of Difference Scale, standard photographs for a randomized subset of 54 infants were rated before treatment and after surgery by an expert clinician blinded to treatment group. Standard blocked and cropped photographs included frontal, basal, left, and right views of the infants. Using the same scale, caregivers rated their infants’ lip, nose, and facial appearance compared with the general population of infants without clefts before treatment and after surgery. Multilevel modeling was used to model change in ratings of infants’ appearance before treatment and after surgery. Results: The expert clinician ratings indicated that nasoalveolar molding–treated infants had more severe clefts before treatment, yet both groups were rated equally after surgery. Nasoalveolar molding caregivers reported better postsurgery outcomes compared with no–nasoalveolar molding caregivers (p < 0.05), particularly in relation to the appearance of the nose. Conclusions: Despite having a more severe cleft before treatment, infants who underwent nasoalveolar molding were found by clinician ratings to have results comparable to those who underwent lip repair alone. Infants who underwent nasoalveolar molding were perceived by caregivers to have better treatment outcomes than those who underwent lip repair without nasoalveolar molding. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Factors Associated With Adherence to Nasoalveolar Molding (NAM) by Caregivers of Infants Born With Cleft Lip and Palate

Objective: Identify factors associated with adherence to nasoalveolar molding (NAM) therapy. Design: Retrospective case-control study. Setting: Tertiary referral center. Patients, Participants: Infants with cleft lip, with or without cleft palate, referred for NAM. One hundred thirty-five patients met criteria. Main Outcome Measure(s): Adherence to NAM therapy, defined as continuous use of the appliance and attendance of NAM adjustment visits. Results: Female sex (OR = 2.85, 95% CI 1.21-6.74), bilateral cleft (OR = 2.88, 95% CI 1.29-6.46), and travel distance (OR = 1.01, 95% CI 1.00-1.01) were independent predictors of nonadherence. Bilateral clefts (OR = 8.35, 95% CI 2.72-25.64) and public-payer insurance (OR = 3.67, 95% CI 1.13-11.91) for male patients were significantly associated with nonadherence, in our sex-stratified multivariate model. The majority of the families (58%) had public health insurance. Males comprised 77.0% of the cohort. Conclusions: NAM treatment adherence is impaired by bilateral clefts, female sex, increased travel distance, and public insurance. Further studies are warranted to investigate how these factors affect adherence, and to develop interventions to improve adherence in families at risk due to economic or psychosocial barriers.

The Role of Nasoalveolar Molding in the Presurgical Management of Infants Born with Cleft Lip and Palate

While the conventional nomenclature of cleft deformity would suggest that only the “lip and palate” are affected, recognition and management of the potentially substantial nasal deformity is necessary in order to achieve an esthetic and functional treatment outcome. In most cleft treatment protocols, the nasal deformity is addressed surgically and requires a number of secondary surgical revisions as the affected individual grows to maturity.