Systematic Review and Critical Appraisal of the Evidence Base for Nasoalveolar Molding (NAM).

OBJECTIVE: To critically appraise the body of scientific literature supporting the risks and efficacy of nasoalveolar molding (NAM), specifically in contrast to alternative methods of presurgical infant orthopedics (PSIO) or to treatment without PSIO. MAIN OUTCOME MEASURES: Five outcome domains were considered: nasolabial aesthetics; dentoalveolar relationship; midfacial growth; cost and burden of care; and number of anesthetic events. DESIGN: MEDLINE, Embase, and Scopus were queried for articles from the first description of the Grayson-Santiago NAM technique (1993) through December 13, 2021. After the application of inclusionary and exclusionary criteria, selected articles were critically appraised using a systematic framework that included risk of bias assessment using the Cochrane RoB 2.0 and ROBINS-I tools. RESULTS: A total of 88 studies were included. Level-I and -II evidence showed on par or better approximation and alveolar alignment achieved by NAM compared to other PSIO. Level-II and -III evidence showed improved nasolabial aesthetics compared to other PSIOs. Level-II and -III evidence supported no harm to maxillofacial skeletal growth through age 12. Sparse level-III evidence supported a reduced number of labial or nasal revisions following NAM. Level-II and -III evidence showed NAM requiring upfront cost and frequent appointments but reducing caregiver psychosocial burden and reducing long-term costs compared to select alternatives. Many studies carried a high risk of bias. CONCLUSIONS: Current evidence supports the overall efficacy of NAM regarding short/mid-term outcomes, with a low risk of negative effects on midfacial growth or dental development. The high risk of bias discovered in many papers underscores the need for robust study design in future research.

Simulation-Based Comprehensive Cleft Care Workshops: A Reproducible Model for Sustainable Education.

OBJECTIVE: Evaluate simulation-based comprehensive cleft care workshops as a reproducible model for education with sustained impact. DESIGN: Cross-sectional survey-based evaluation. SETTING: Simulation-based comprehensive cleft care workshop. PARTICIPANTS: Total of 180 participants. INTERVENTIONS: Three-day simulation-based comprehensive cleft care workshop. MAIN OUTCOME MEASURES: Number of workshop participants stratified by specialty, satisfaction with the workshop, satisfaction with simulation-based workshops as educational tools, impact on cleft surgery procedural confidence, short-term impact on clinical practice, medium-term impact on clinical practice. RESULTS: The workshop included 180 participants from 5 continents. The response rate was 54.5%, with participants reporting high satisfaction with all aspects of the workshop and with simulation-based workshops as educational tools. Participants reported a significant improvement in cleft lip (33.3 ± 5.7 vs 25.7 ± 7.6; P < .001) and palate (32.4 ± 7.1 vs 23.7 ± 6.6; P < .001) surgery procedural confidence following the simulation sessions. Participants also reported a positive short-term and medium-term impact on their clinical practices. CONCLUSION: Simulation-based comprehensive cleft care workshops are well received by participants, lead to improved cleft surgery procedural confidence, and have a sustained positive impact on participants' clinical practices. Future efforts should focus on evaluating and quantifying this perceived positive impact, as well reproducing these efforts in other areas of need.

Principles of Cleft Lip Repair: Conventions, Commonalities, and Controversies.

LEARNING OBJECTIVES: After reading this article, the participant should be able to: 1. Understand the principles of contemporary methods for repair of unilateral and bilateral cleft lip. 2. Understand the design elements of a poor repair that predispose to a suboptimal outcome. SUMMARY: The authors describe the evaluation and management of unilateral and bilateral cleft lip (with or without cleft alveolus and with or without cleft palate). Each deformity is presented in a "principles-based" manner. For unilateral cleft lip, the authors discuss common modifications of rotation-advancement and Fisher's anatomical subunit approach. In expert hands, both techniques can give excellent results. For bilateral cleft lip, Mulliken's method is presented. Methods for synchronous correction of the cleft lip nasal deformity are also discussed.

Management of the alveolar cleft.

Orthopedic and orthodontic management of patients born with clefts of the lip, alveolus and palate is based on the application of basic biomechanical principles adapted to the individualized cleft anatomy. This article focuses on orthopedic and orthodontic preparation for 2 stages of interdisciplinary orthodontic/surgical cleft care: presurgical infant orthopedics (nasoalveolar molding) for lip/alveolus/nasal surgical repair and maxillary arch preparation for secondary alveolar bone grafting. These preparatory stages of orthopedic/orthodontic therapy are undertaken with the goal of restoring normal anatomic relationships to assist the surgeon in providing the best possible surgical care.

Complications and solutions in presurgical nasoalveolar molding therapy.

OBJECTIVE: To outline three main categories of nasoalveolar molding complications, describe their etiologies and manifestations, and prescribe preventive and palliative therapy for their proper management. Estimates of the incidence of each complication also are provided. MATERIALS AND METHODS: Data were collected retrospectively from the charts of 27 patients with complete unilateral cleft lip and palate treated by the first author (D.L.-B.) at the University of Puerto Rico (n = 12) and the Medical College of Georgia (n = 15). Confidence intervals for the true incidence of each complication were calculated using exact methods based on the binomial distribution. A significance level of .05 was used for all statistical tests. RESULTS: Of the soft and hard tissue complications considered, only one (tissue irritation) had an estimated incidence greater than 10%. Compliance issues were of greater concern, with an estimated incidence of 30% for broken appointments and an estimated incidence of 26% for removal of the nasoalveolar molding appliance by the tongue. CONCLUSIONS: Although benefits outnumber the complications, it is important to address all complications in order to prevent any deleterious outcomes.

Three-dimensional nasal changes following nasoalveolar molding in patients with unilateral cleft lip and palate: geometric morphometrics.

OBJECTIVE: To evaluate three-dimensional changes in nasal morphology in patients with unilateral cleft lip and palate treated with presurgical nasoalveolar molding (NAM) to correct naso-labio-alveolar deformity. DESIGN: This was a prospective, longitudinal study. Digital stereophotogrammetry was used to capture three-dimensional facial images, and x, y, and z coordinates of 28 nasal landmarks were digitized. SAMPLE: Ten patients with unilateral cleft lip and palate. MAIN OUTCOME MEASURES: Nasal form changes between T1 (age: 28 +/- 2 days, pre-NAM) and T2 (age: 140 +/- 2 days, post-NAM), using conventional measurements and finite-element scaling analysis. RESULTS: Overall nasal changes were statistically different (p < .01), but no linear or curvilinear changes were found. Specifically, relative size increases were found on the noncleft side, involving the upper nose (30%), alar depth (20%), alar dome (30%), columella height (30%), and lateral wall of the nostril (17%). On the cleft side, the following showed a size increase: upper nose (8%), alar dome (5%), columella height (30%), and lateral wall of the nostril (30%). The cleft-side alar curvature, however, showed a large decrease in size (80%), but no changes on the noncleft side were found. Corresponding shape changes and angular changes were also found. CONCLUSIONS: Using NAM, bilateral nasal symmetry in patients with unilateral cleft lip and palate was improved before surgical repair. Furthermore, slight overcorrection of the alar dome on the cleft side using pressure exerted by the nasal stent is indicated to maintain the NAM result.

The effect of an early Le Fort III surgery on permanent molar eruption.

The purpose of this retrospective study was to evaluate the extent to which an early Le Fort III osteotomy affects the position and eruption of the permanent maxillary first and second molars. To test the null hypothesis that there are no changes in eruption patterns, 31 patients diagnosed with craniosynostoses (13 with Crouzon's syndrome, nine with Apert's syndrome, eight with Pfeiffer's syndrome, and one with Carpenter's syndrome) with a mean age at the time of surgery of 5.3 +/- 1.3 years were studied. All patients underwent a Le Fort III osteotomy performed by a single surgeon to correct the anatomical deformity for functional and psychosocial reasons. Eighteen patients with craniosynostoses who had not been operated on (11 with Crouzon's syndrome, four with Apert's syndrome, and three with Pfeiffer's syndrome) served as controls; they had a mean age of 21.2 +/- 9.5 years. First and second molar positions and eruption patterns were assessed separately on panoramic radiographs by three observers. For the patients who underwent surgery, long-term evaluation showed that although 79 percent of all first molars erupted compared with 100 percent for the control group (p < 0.001), only 18 percent of all second permanent molars erupted compared with 89 percent for the control group (p < 0.0001). The authors conclude that in a significant minority of cases, early Le Fort III osteotomy affects first molar eruption, whereas the probability of second molar eruption is significantly decreased in the majority of cases. Therefore, Le Fort III osteotomy sites should be positioned distal to the second molar tooth buds. If this is not possible, patients, parents, and dental professionals should be made aware of these early postosteotomy sequelae so that later treatment planning can be enhanced.