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One-Year Stability of LeFort I Advancement in Patients With Complete Cleft Lip and Palate Using a Standardized Clinical and Surgical Protocol

Parikh, Vrajkumar; Gonchar, Marina; Gibson, Travis L; Grayson, Barry H; Cutting, Court B; Shetye, Pradip R
AIM/OBJECTIVE:To assess treatment outcome and 1-year stability of LeFort I advancement in patients with complete cleft lip and palate. METHODS:Thirty-five patients (age 20.65 ± 2.20 years) with unilateral (n = 25) or bilateral (n = 10) complete cleft lip and palate who underwent LeFort I advancement were included.Lateral cephalograms before surgery (T1), immediately postsurgery (T2), and at 1-year follow-up (T3) were superimposed, and the position of anterior nasal spine (ANS), A-point, and U1 Tip assessed using an x, y coordinate system. Differences between landmark positions at the 3-time points were analyzed using paired sample t-tests, with a significance defined as α ≤ 0.05. RESULTS:The mean surgical advancement in the horizontal direction (T2-T1) was 6.50 ± 2.62 mm at ANS (P < 0.001) and 7.05 ± 2.51 mm at A-point (P < 0.001). At a 1-year follow-up (T3-T2), the mean horizontal relapse at ANS was -1.41 ± 1.89 mm (P < 0.001) and -0.79 ± 1.48 mm at A-point (P 0.003). Mean horizontal relapse was 21.7% and 11% of surgical advancement when assessed at ANS and A-point, respectively. The central incisor tip position remained stable during the postsurgical period (0.12 ± 2.11 mm, P 0.732). At A-point, the mean vertical surgical change (T2-T1) was -0.96 ± 2.57 mm (P < 0.001). No significant post-treatment (T3-T2) vertical changes were detected at ANS or A-point. Phenotypic stability was excellent, with all patients maintaining positive overjet at 1-year follow-up. CONCLUSIONS:LeFort I advancement in complete cleft lip and palate is stable, with less than a 2 mm relapse after 1-year. Surgical overcorrection by 10% to 20% is recommended to compensate for the expected skeletal relapse.
PMID: 34260467
ISSN: 1536-3732
CID: 4938632

Prevalence of Dental Anomalies in Patients With Unilateral Cleft Lip and Alveolus Treated With Gingivoperiosteoplasty

Gibson, Travis L; Grayson, Barry H; Cutting, Court B; Shetye, Pradip R
OBJECTIVE/UNASSIGNED:To compare the prevalence of dental malformations and agenesis in patients who received or did not receive gingivoperiosteoplasty (GPP). DESIGN/UNASSIGNED:Retrospective cohort study. PATIENTS/UNASSIGNED:Review of patients born January 1, 2000, to December 31, 2007, with unilateral cleft lip and alveolus, with or without clefting of the secondary palate, who received GPP and/or secondary alveolar bone grafting (ABG). Patients were included if they had clinical images and dental radiographs available at ages 5 to 9 and 10 to 12 years. Ninety-four patients met the inclusion criteria; 46 treated with GPP, and 48 who did not receive GPP. OUTCOME MEASURES/UNASSIGNED:tests. RESULTS/UNASSIGNED:Cleft side lateral incisors were absent in 54% of GPP patients, compared to 50% in the no-GPP group. Two patients in the GPP group and 1 in the no-GPP group had supernumerary lateral incisors. Most lateral incisors were undersized or peg shaped in both the no-GPP (83.3%) and GPP (71.4%) groups. In the GPP group, 5 (10.9%) patients exhibited central incisor agenesis, and 3 had significant hypoplasia. In the no-GPP group, 4 (8.3%) patients exhibited central incisor agenesis, and 5 (10.5%) significant hypoplasia. These differences were not statistically significant. CONCLUSIONS/UNASSIGNED:Gingivoperiosteoplasty was not associated with increased prevalence of dental malformation or agenesis. When performed appropriately, GPP is a safe treatment technique that does not increase the risk of dental anomalies.
PMID: 34259074
ISSN: 1545-1569
CID: 4938562

Skeletal and Dental Stability Following Different Magnitude of Le Fort I Advancement in Patients With Cleft Lip and Palate

Wangsrimongkol, Buddhathida; Flores, Roberto L; Staffenberg, David A; Rodriguez, Eduardo D; Shetye, Pradip R
PURPOSE/OBJECTIVE:The purpose of this study was to measure the association between the magnitude of advancement and dental and skeletal relapse in patients with cleft lip and palate (CLP). METHODS:A single-institution retrospective cohort study of skeletally matured patients with CLP who underwent isolated Le Fort I advancement surgery between 2013 and 2019 was studied. Patients were included if they had lateral cephalograms or cone-beam computed tomography (CBCT) at preoperative (T1), immediately postoperative (T2), and 1-year follow-up (T3). Lateral cephalometric landmarks were digitized and measured. The sample was divided on the basis of the magnitude of skeletal advancement: minor (<5 mm), moderate (≥5 but <10 mm), and major (≥10 mm) advancement groups. The mean advancement and relapse were compared between groups using 1-way ANOVA. Correlation between the amount of surgical advancement and relapse was evaluated. RESULTS:Forty-nine patients with nonsyndromic CLP with hypoplastic maxilla met inclusion criteria and the sample consisted of 36 males and 13 females with the mean age of 19.5 years. In the minor, moderate, and major advancement groups, the mean advancement at point A was +4.1 ± 0.4, + 7.5 ± 1.4, and +11.3 ± 1.3 mm, respectively. At 1-year follow-up, the mean relapse at point A was -1.3 ± 1.2, -1.1 ± 1.2, and -1.7 ± 1.5 mm, respectively. There was no significant difference in the relapse amount between all surgical groups. No correlation between the magnitude of advancement and relapse was found. CONCLUSIONS:This study demonstrated no statistically significant difference in skeletal stability between a minor (<5 mm), moderate (≥5 but <10 mm), and major (≥10 mm) Le Fort I advancement groups in patients with clefts. Regardless of the degree of advancement, mild skeletal relapse was observed in all 3 groups.
PMID: 34153247
ISSN: 1531-5053
CID: 4918192

Simulation-based comprehensive cleft care workshops: A reproducible model for sustainable education [Meeting Abstract]

Melhem, A; Al, Abyad O; Chahine, E; Breugem, C; Keith, K; Kassam, S; Vijayakumar, C; Bow, M; Alfonso, A; Esenlik, E; Patel, K; Shetye, P; Santiago, P; Losee, J; Steinbacher, D; Kummer, A; Flores, R; Rossell-Perry, P; Garib, D; Alonso, N; Mann, R; Pamplona, M; Giugliano, C; Prada-Madrid, J R; Padwa, B; Raposo-Amaral, C -E; Sommerlad, B; Tse, R; Bennun, R; Collares, M; Kantar, R; Hamdan, U
Background/Purpose: Newborns with cleft lip and/or palate (CLP) exceed 100 000 per year in low- and middle-income countries (LMICs). Patients, if left untreated, are at high risk of morbidity, due to functional deficits, malnutrition, aspiration, and infections. Limited resources in LMICs create barriers for establishing Interdisciplinary Cleft Care programs. Surgical missions driven by nonprofit organizations have been able to partially address this need, but their ability to promote long-term sustainable cleft care has come to a question. Simulation-based training has emerged as an essential tool for enhancing medical education and training. Global Smile Foundation, a nonprofit organization, is a leader in the establishment of Interdisciplinary Cleft Care programs, with its volunteers being involved in cleft care for over 3 decades. We were able to demonstrate the efficacy of our first Simulation-Based Comprehensive Cleft Care Workshop (SBCCW), in the Middle East-North Africa (MENA) region, and its wide acceptance by our recipients. In the current study, we want to prove the effectiveness and successfulness of our second SBCCW, in Latin America. Methods/Description: Our second SBCCW took place in Lima, Peru, in October 2019. Hands-on simulations of CLP repair using highfidelity CLP simulators were also provided to our participants. Participants were asked to complete a satisfaction survey at the end. Attendees were also asked about the obstacles facing cleft care in their countries and the possible interventions to overcome these obstacles. Short-term (at the end of the SBCCW) and medium-term (6 months later) follow ups were conducted by our team collecting data about improvements in the participants' competence, performance, outcomes, clinical care, and whether the SBCCW has changed their practice. Procedural confidence for pre- and postsimulation was evaluated using the psychometrically validated tool for measuring selfconfidence during surgical learning. Descriptive statistics were used for the collected data. Data analyses were performed using the Statistical Package for the Social Sciences. XXResult(s): Ninety-eight of the 198 participants from 29 different countries filled the satisfaction survey at the end of the workshop. The 2 most common barriers to cleft care in LMICs identified by our participants are the absence of financial support and the absence of multidisciplinary teams. Respondents claimed an improvement in their procedural confidence after the simulation sessions. Respondents had consistent short-term and medium-term impressions about the SBCCW positively impacting their competence, performance, outcomes, clinical care, and even changing their practice. XXConclusion(s): This study provides evidence that implementation of a SBCCW leads to a significantly improved procedural confidence, as well as a sustained positive impact on the clinical practice of the participants, reinforcing its role as a cleft care capacity-building tool
EMBASE:635187570
ISSN: 1545-1569
CID: 4911892

Three-Dimensional Nasolabial Changes After Nasoalveolar Molding and Primary Lip/Nose Surgery in Infants With Bilateral Cleft Lip and Palate

Mancini, Laura; Avinoam, Shayna; Grayson, Barry H; Flores, Roberto L; Staffenberg, David A; Shetye, Pradip R
OBJECTIVE/UNASSIGNED:Utilize 3-dimensional (3D) photography to evaluate the nasolabial changes in infants with bilateral cleft lip and palate (BCLP) who underwent nasoalveolar molding (NAM) and primary reconstructive surgery. DESIGN/UNASSIGNED:coordinates to obtain the linear and angular measurements. Nasal form changes were measured and analyzed between T1 (0.5 months old), T2 (5 months old), and T3 (6 months old). Intraclass correlation coefficient was performed for intrarater reliability. Averaged data from the 3D images was statistically analyzed from T1 to T2 and T2 to T3 with Wilcoxon tests. Unaffected infant norms from the Farkas publication were used as a control sample. RESULTS/UNASSIGNED:After NAM therapy, statistically significant changes in the position of subnasale and labius superius improved nasolabial symmetry. Both retruded after NAM were displaced downward after NAM and surgical correction with respect to soft tissue nasion. The nasal tip's projection was maintained with NAM and surgical correction. The columella lengthened from 1.4 to 4.71 mm following NAM. CONCLUSIONS/UNASSIGNED:There was a significant improvement in the nasolabial anatomy after NAM, and this was further enhanced after primary reconstructive surgery.
PMID: 34032145
ISSN: 1545-1569
CID: 4887702

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

Yarholar, Lauren M; Shen, Chen; Wangsrimongkol, Buddhathida; Cutting, Court B; Grayson, Barry H; Staffenberg, David A; Shetye, Pradip R; Flores, Roberto L
BACKGROUND:The authors present outcomes analysis of the nasoalveolar molding treatment protocol in patients with a cleft followed from birth to facial maturity. METHODS:A single-institution retrospective review was conducted of cleft patients who underwent nasoalveolar molding between 1990 and 2000. Collected data included surgical and orthodontic outcomes and incidence of gingivoperiosteoplasty, alveolar bone grafting, surgery for velopharyngeal insufficiency, palatal fistula repair, orthognathic surgery, nose and/or lip revision, and facial growth. RESULTS:One hundred seven patients met inclusion criteria (69 with unilateral and 38 with bilateral cleft lip and palate). Eighty-five percent (91 of 107) underwent gingivoperiosteoplasty (unilateral: 78 percent, 54 of 69; bilateral: 97 percent, 37 of 38). Of those patients, 57 percent (52 of 91) did not require alveolar bone grafting (unilateral: 59 percent, 32 of 54; bilateral: 54 percent, 20 of 37). Twelve percent (13 of 107) of all study patients underwent revision surgery to the lip and/or nose before facial maturity (unilateral: 9 percent, six of 69; bilateral: 18 percent, seven of 38). Nineteen percent (20 of 107) did not require a revision surgery, alveolar bone grafting, or orthognathic surgery (unilateral: 20 percent, 14 of 69; bilateral: 16 percent, six of 38). Cephalometric analysis was performed on all patients with unilateral cleft lip and palate. No significant statistical difference was found in maxillary position or facial proportion. Average age at last follow-up was 20 years (range, 15 years 4 months to 26 years 10 months). CONCLUSIONS:Nasoalveolar molding demonstrates a low rate of soft-tissue revision and alveolar bone grafting, and a low number of total operations per patient from birth to facial maturity. Facial growth analysis at facial maturity in patients who underwent gingivoperiosteoplasty and nasoalveolar molding suggests that this proposal may not hinder midface growth. CLINICAL QUESTION/LEVEL OF EVIDENCE/METHODS:Therapeutic, IV.
PMID: 33890899
ISSN: 1529-4242
CID: 4847552

Skeletal and Dental Correction and Stability Following LeFort I Advancement in Patients With Cleft Lip and Palate With Mild, Moderate, and Severe Maxillary Hypoplasia

Wangsrimongkol, Buddhathida; Flores, Roberto L; Staffenberg, David A; Rodriguez, Eduardo D; Shetye, Pradip R
OBJECTIVE/UNASSIGNED:This study evaluates skeletal and dental outcomes of LeFort I advancement surgery in patients with cleft lip and palate (CLP) with varying degrees of maxillary skeletal hypoplasia. DESIGN/UNASSIGNED:Retrospective study. METHOD/UNASSIGNED:: ≤-10 mm. PARTICIPANTS/UNASSIGNED:Fifty-one patients with nonsyndromic CLP with hypoplastic maxilla who met inclusion criteria. INTERVENTION/UNASSIGNED:LeFort I advancement. MAIN OUTCOME MEASURE/UNASSIGNED:Skeletal and dental stability post-LeFort I surgery at a 1-year follow-up. RESULTS/UNASSIGNED:At T2, LeFort I surgery produced an average correction of maxillary hypoplasia by 6.4 ± 0.6, 8.1 ± 0.4, and 10.7 ± 0.8 mm in the mild, moderate, and severe groups, respectively. There was a mean relapse of 1 to 1.5 mm observed in all groups. At T3, no statistically significant differences were observed between the surgical groups and controls at angle Sella, Nasion, A point (SNA), A point, Nasion, B point (ANB), and overjet outcome measures. CONCLUSIONS/UNASSIGNED:LeFort I advancement produces a stable correction in mild, moderate, and severe skeletal maxillary hypoplasia. Overcorrection is recommended in all patients with CLP to compensate for the expected postsurgical skeletal relapse.
PMID: 33722088
ISSN: 1545-1569
CID: 4817482

Nasal Duplication: A Review of Literature and Case Report

Shen, Chen; Shetye, Pradip R; Flores, Roberto L
INTRODUCTION/UNASSIGNED:Nasal duplication is a rare congenital deformity with many subtypes including supernumerary nostril. The challenge of surgical correction is to achieve nasal symmetry and restore nasal airflow. However, there is no defined protocol for treatment, especially with regard to presurgical therapy. METHODS/UNASSIGNED:We performed a review of literature of studies reporting on patients with supernumerary nostril to complete this review. We then report on a patient with supernumerary nostril who was treated with nostril expansion therapy prior to surgical intervention. RESULTS/UNASSIGNED:We identified 59 cases of nostril duplication. Because of the rarity of the condition, treatment protocols varied greatly. For our patient, preoperative nasal appliance therapy was implemented for 3 months prior to surgical intervention. Patient was followed-up regularly for 1 year. DISCUSSION/UNASSIGNED:Although literature on nasal duplication is scarce, there is a general agreement that early intervention has psychological, anatomic, and functional benefits to the patient. In our case report, nostril expansion therapy was easy to implement and facilitated surgical reconstruction, resulting in aesthetic outcome and expanded airway 1 year postoperatively.
PMID: 33054357
ISSN: 1545-1569
CID: 4642772

Sociodemographic Predictors of Treatment Success and Difficulty in Nasoalveolar Molding

Gibson, Travis L; Grayson, Barry H; Shetye, Pradip R
OBJECTIVE/UNASSIGNED:To assess social and demographic influences on caregiver success and difficulty with nasoalveolar molding (NAM). DESIGN/UNASSIGNED:Retrospective review identified patients who began NAM between April 22, 2013, and April 18, 2017, at the New York University Langone Medical Center. Records were reviewed, and the following sociodemographic data retrieved: parental marital status, parental ages, number of siblings, distance traveled to clinic, insurance coverage, concurrent medical conditions, and need for an interpreter. PATIENTS/UNASSIGNED:Patients were included if complete charting was available; 106 patients met the inclusion criteria; 79 patients with unilateral and 27 with bilateral clefts. OUTCOME MEASURES/UNASSIGNED:Chart entries indicating incorrect appliance usage, emergency visits, phone calls, and noncompliance were recorded. Alveolar cleft gap closure was measured on pre- and posttreatment models in unilateral cases. Multiple regression analyses were performed to assess the influence of social variables on these outcomes. RESULTS/UNASSIGNED:= .019). CONCLUSIONS/UNASSIGNED:Alveolar cleft gap closure was more successful for older fathers, younger mothers, and married couples. Married couples were also less likely to experience treatment difficulties such as incorrect appliance usage or inadequate duration of wear, as were those with private insurance coverage.
PMID: 32840124
ISSN: 1545-1569
CID: 4576232

The Effects of Nasoalveolar Molding on Nasal Proportions at the Time of Nasal Maturity

Maliha, Samantha G; Kantar, Rami S; Gonchar, Marina N; Eisemann, Bradley S; Staffenberg, David A; Shetye, Pradip R; Grayson, Barry H; Flores, Roberto L
BACKGROUND/UNASSIGNED:The aim of this study is to assess the effect of nasoalveolar molding (NAM) versus no-NAM on nasal morphology in patients with unilateral cleft lip and palate (UCLP) at the time of nasal maturity. METHODS/UNASSIGNED:A retrospective, single-institution review was conducted on all non-syndromic patients with UCLP. Inclusion criteria included age 14 years or above, unilateral cleft repair at the time of infancy, and adequate photography taken at nasal maturity and prior to rhinoplasty. Exclusion criteria included age less than 14 years, syndromic diagnosis, and rhinoplasty prior to nasal maturity. Ten parameters were measured twice from standardized clinical photographs using the Dolphin Imaging Software for establishment of intrarater reliability. Subjective analysis was achieved through completion of the Asher McDade grading scale by 3 expert cleft practitioners. RESULTS/UNASSIGNED:Nostril height, columellar angle, alar cant, vertical alar height, alar height angle, nasofacial angle, and nasolabial angle were found to be significantly less severe in patients who had undergone NAM in conjunction with surgical repair when compared with those who had undergone surgical repair alone. Asher McDade grading revealed significant improvement in nasal form, nasal symmetry/deviation, nasal profile, vermillion border, and overall score in patients who underwent NAM compared to no-NAM. CONCLUSION/UNASSIGNED:The use of presurgical NAM during infancy can improve nasal symmetry and nasal proportions at the time of nasal maturity.
PMID: 32851868
ISSN: 1545-1569
CID: 4575782