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PLANA Therapy for Infants With Bilateral Cleft Lip and Palate-Two Case Reports
Shetye, Pradip R
Infants with complete bilateral cleft lips and a significantly protruded premaxilla present considerable challenges for the surgeon during the primary lip and nasal reconstruction. Current presurgical infant orthopedics (PSIOs) methods to reduce cleft severity-such as lip adhesion surgery, the Latham appliance, and nasoalveolar molding-often increase the burden of care. Presurgical lip, nose alveolar approximation (PLANA) therapy offers an alternative that effectively reduces this burden. This case report describes the use of PLANA therapy in two infants with bilateral cleft lip and palate, one with mild and one with a significantly protruded premaxilla. PLANA utilizes medical adhesive lip taping and a prefabricated series of nasal silicone devices to retract the premaxilla while promoting nasal tip projection and gradual controlled columellar elongation. The combined action of hydrocolloid lip tapes and nasal devices supports early presurgical objectives and minimizes caregiver demands and prepares patients for primary reconstruction surgery. These two-case reports also address the variations in premaxillary retraction among infants with and without protruded premaxilla.
PMID: 42080940
ISSN: 1545-1569
CID: 6030872
20-Year Outcomes and Revision Surgery Rates in a Large Cohort of Patients Undergoing Nasoalveolar Molding Therapy
Plana, Natalie M; Perez Rivera, Lucas R; Lusk, Rebecca; Cutting, Court; Staffenberg, David A; Shetye, Pradip R; Flores, Roberto L
INTRODUCTION/BACKGROUND:Nasoalveolar molding (NAM) is a presurgical technique used to improve nasolabial cleft severity prior to repair. This study ascertains the rates of revision surgery in a large cohort of patients with a cleft who underwent NAM and were followed to facial maturity. METHODS:A single-institution retrospective review of all patients with a cleft who underwent NAM from 1995 to 2005 was performed. Operative reports were queried to record intervnetions to the lip and nose performed through facial maturity. Patients with incomplete medical records prior to reaching skeletal maturity were excluded. Pearson correlation coefficient and two-paired student t-tests were employed for data analysis. RESULTS:A total of 81 patients were studied, 46 male and 35 female, with 52(64%) unilateral and 29(36%) bilateral clefts. Average age at last follow-up was 18.8 years. Revision to the lip was carried out in 36(44%) of patients, and only 3(3.7%) prior to reaching facial maturity. Re-repair was performed in 10(12%) patients. No significant difference of lip revisions rates were seen among patients with a bilateral and unilateral cleft (48% v. 37.9%, p=0.38).Immature cleft rhinoplasty was performed in 3(4%) patients, and more commonly among patients with a unilateral (23%) than bilateral cleft (10%), p=0.18. Mature rhinoplasty was performed in 46(57%) patients, similarly between unilateral (58%) and bilateral clefts (55%). Nasal revision following mature rhinoplasty was performed in 8(10%) patients. CONCLUSIONS:Nasoalveolar molding is an effective adjunct to surgical management in reducing the burden of operative revisions as patients reach facial maturity, namely for bilateral clefts.
PMID: 42053286
ISSN: 1529-4242
CID: 6029292
A Comparative Assessment of Surgeon Appraisal of Presurgical Infant Orthopedics Outcomes Using PLANA and NAM
Perez Rivera, Lucas R; Tanikawa, Daniela Y S; Chong, David K; Flores, Roberto L; Shetye, Pradip R
Presurgical lip, alveolus, and nose approximation (PLANA) is a novel form of presurgical infant orthopedics (PSIO) involving a prefabricated silicone intranasal device combined with hydrocolloid adhesive lip taping. Early studies have demonstrated favorable nasolabial morphologic outcomes using PLANA and a reduction in the burden of care on infants and their caregivers relative to nasoalveolar molding (NAM). However, the efficacy of PLANA in reducing cleft severity to facilitate surgical repair has not been comprehensively assessed from the perspective of the cleft surgeon. This study, therefore, compared surgeon ratings of PSIO outcomes in infants with unilateral cleft lip treated with PLANA and NAM. Two expert surgeons blindly evaluated PSIO outcomes in 10 patients treated with PLANA and 10 patients treated with NAM using standardized pre- and post-PSIO photographs. Surgeons used a 4-point Likert scale to assess improvement in lip approximation, lateral displacement of the subnasale from the midsagittal plane, nasal deviation, alar base width symmetry, alar base height symmetry, columellar angle, columellar length, nostril width symmetry, nostril height symmetry, and nasal tip projection, as well as overall morphologic improvement. The PLANA cohort received statistically significantly greater scores for alar base width symmetry (3.45 versus 2.35, P<0.001), alar base height symmetry (3.40 versus 2.55, P=0.02), columellar angle (3.70 versus 3.10, P=0.05), nostril width symmetry (3.65 versus 2.20, P<0.001), and overall outcome (3.65 versus 2.90, P=0.02). The 2 cohorts received similar ratings across all other parameters. Surgeons consistently rated PSIO outcomes as equivalent or superior with PLANA relative to NAM.
PMID: 41940938
ISSN: 1536-3732
CID: 6025102
An Early Comparative Analysis of Presurgical Lip, Alveolus and Nose Approximation (PLANA) and Nasoalveolar Molding (NAM)
Multani, Neha; Plana, Natalie M; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
BACKGROUND:This study evaluates the Presurgical Lip, Alveolus, and Nose Approximation (PLANA) technique as a novel alternative to NasoAlveolar molding (NAM). The study hypothesizes that PLANA can achieve comparable Nasolabial outcomes to NAM while addressing its limitations, particularly by reducing the burden of care. METHODS:A retrospective review was conducted on 50 patients with non-syndromic unilateral or bilateral cleft lip and palate (CLP) treated with either NAM (n=28, including 2 treatment discontinuations) or PLANA (n=22). The overall physical burden of care was assessed in the full cohort. A subset of 25 patients with complete unilateral CLP (PLANA n=12; NAM n=13) was further analyzed to assess changes in nasolabial anthropometric ratios between cleft and non-cleft side using standardized 2D photographs taken pre-treatment (T1) and post-treatment (T2). RESULTS:The physical burden of care was significantly lower in the PLANA group, with 61.2 % fewer total office visits (5.2 vs. 13.4; p<0.001). The PLANA group also showed 72.19 % reduction in transient reversible side effects, such as oral, nasal, and cheek irritations (18.18% [n=4] vs. 65.38% [n=17]; p<0.001). PLANA achieved a significantly greater improvement in the columellar length ratio (0.53 vs. 0.37; p = 0.026), while NAM demonstrated a greater increase in the nostril height ratio (0.29 vs. 0.39; p = 0.04). No significant differences were observed in nostril width and alar base width ratios, or columellar deviation angle between the groups. CONCLUSION/CONCLUSIONS:These findings suggest that PLANA significantly reduces the burden of care for patients with cleft lip and palate and may offer comparable nasolabial outcomes to NAM.
PMID: 40794405
ISSN: 1529-4242
CID: 5907092
"Anthropometrics versus Experts' Subjective Analysis of Cleft Severity and PSIO Outcomes in Unilateral Clefts: A Proposal for a New Grading."
Tanikawa, Daniela Y S; Chong, David; Fisher, David; Alonso, Nivaldo; Shetye, Pradip R; Batra, Puneet; Flores, Roberto; Figueroa, Álvaro A
BACKGROUND:The severity of unilateral cleft lip significantly influences surgical outcomes, yet no standardized system exists to classify cleft severity or assess the impact of presurgical infant orthopedics (PSIO). This study proposes an objective classification system integrating anthropometric measurements with expert evaluations. METHODS:Deidentified pre- and post-PSIO photographs of 50 infants with unilateral cleft lip from the Smile Train Express database were analyzed. Three anthropometric parameters-nostril width ratio (NWR), columellar angle (CA), and subnasale lateral displacement (SN)-were measured. An expert panel of orthodontists and surgeons independently rated cleft severity and PSIO outcomes in a structured three-stage process. Severity thresholds were established through consensus, and interrater agreement was analyzed using weighted kappa. RESULTS:Consensus-derived thresholds categorized NWR, CA, and SN into four severity levels. Interrater agreement for cleft severity improved across stages, reaching near-perfect levels in Stage 3 (weighted kappa = 0.91 pre-PSIO, 0.93 post-PSIO). While pre-PSIO agreement was similar between surgeons and orthodontists, post-PSIO assessments showed greater variability. PSIO had a disproportionate effect on nasal morphology (CA) compared to maxillary segments (NWR, SN), with severe NWR and SN frequently coexisting with mild CA. The proposed classification system demonstrated substantial reliability, aligning at least two parameters within the same severity subclassification. CONCLUSIONS:This study introduces a standardized classification system for cleft severity and PSIO outcomes, demonstrating strong interrater reliability. By integrating anthropometric data with expert assessments, it provides a reproducible framework for clinical and research applications. Further refinements, including intraoral measurements and 3D imaging, may enhance its precision and applicability.
PMID: 40707056
ISSN: 1529-4242
CID: 5901862
Evaluating Weight Gain in Infants Treated With Presurgical Lip, Alveolus, and Nose Approximation (PLANA): A Pilot Study
Perez Rivera, Lucas R; Rosa-Chaves, Melanie; Multani, Neha; Plana, Natalie M; Malkoff-Cohen, Deborah; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R; Lico, Margaret M
Presurgical lip, alveolus, and nose approximation (PLANA) is a novel form of presurgical infant orthopedics (PSIO) designed without an intraoral molding plate. While early studies on PLANA have demonstrated improvements in nasolabial morphology, its impact on infant feeding and weight gain has not been assessed. A single-institution, retrospective review of all patients with cleft lip and palate (CL±P) treated with PLANA over a 1-year period was therefore performed. Weight values at baseline and at surgery were compared with World Health Organization (WHO) Child Growth Standards, and weight-for-age z-scores (WAZ) as well as changes in weight-for-age z-scores (WAZ) were obtained. A cohort of patients who underwent PSIO with NasoAlveolar Molding (NAM) was evaluated as a reference group. The PLANA (n=19) and NAM (n=25) groups were comparable in age (15.63 versus 21.16 d, P=0.2), weight (3.38 versus 3.50 kg, P=0.2), and WAZ (-0.80 versus -0.94, P=0.8) at baseline, and in age (103.11 versus 113.04 d, P=0.06), weight (5.82 versus 5.68 kg, P=0.3), and WAZ (-0.92 versus -1.47, P=0.2) at surgery. Both groups had similar weight gain (2.44 versus 2.18 kg, P=0.1) and WAZ (-0.12 versus -0.53, P=0.2). The PLANA group exhibited statistically significant greater daily weight gain (0.028 versus 0.024 kg/d, P=0.04). None of the patients experienced surgical delays due to insufficient weight gain. PLANA did not interfere with presurgical weight gain in infants with CL±P.
PMID: 41129194
ISSN: 1536-3732
CID: 5957112
Quantification of Skeletal Paranasal Asymmetry in Patients With Unilateral Cleft Lip and Palate
Richmond, Daniel N; Groysman, Leya; Laspro, Matteo; Flores, Roberto L; Staffenberg, David A; Shetye, Pradip R
Patients with unilateral cleft lip and palate (UCLP) often exhibit asymmetric paranasal flatness of soft tissues. Despite clinical recognition of this asymmetry, skeletal paranasal asymmetry remains poorly quantified. Measuring skeletal landmark asymmetries can aid in planning surgical maxillary yaw corrections that simultaneously enhance paranasal symmetry and maxillary dental midline position. This study aims to quantify skeletal paranasal asymmetry in patients with UCLP. Skeletally mature patients with complete UCLP who were orthodontically prepared for orthognathic surgery between 2014 and 2023 were included in this study. Presurgical CBCTs were analyzed using Dolphin 3D. Anterior-posterior discrepancies between affected and unaffected sides were measured at the most lateral point of piriform aperture (PA) and 15 mm lateral to PA (15PA). A one-sample t test was conducted. Analysis of 30 patients (mean age 18-8 y, 17 male, 13 female, 20 left-sided, 10 right-sided) was completed. On the affected side, PA and 15PA were positioned 3.8 mm (P<0.05) and 2.4 mm (P<0.05) more posteriorly, respectively. These results suggest that skeletal paranasal asymmetry should be assessed during the pretreatment stage, as presurgical orthodontics should maintain a maxillary midline deviation toward the affected side when yaw correction is indicated. This approach facilitates simultaneous correction of piriform projection and midline alignment during surgery and may reduce the need for secondary procedures, such as malar implants or fat injections, which add cost and morbidity. This study confirms skeletal paranasal asymmetry in patients with UCLP and establishes a standardized method for measuring these deficiencies using CBCT-based skeletal landmarks.
PMID: 40773357
ISSN: 1536-3732
CID: 5905292
The Burden of Care of Nasoalveolar Molding: An Institutional Experience
Alfonso, Allyson R; Park, Jenn J; Kalra, Aneesh; DeMitchell-Rodriguez, Evellyn M; Kussie, Hudson C; Shen, Chen; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
Nasoalveolar molding (NAM) is an early presurgical intervention to facilitate primary cleft lip repair by reducing cleft severity and improving labial and nasal form. However, it continues to be associated with the burden of care that influences access and completion of therapy. The authors, therefore, aim to determine the burden of care of NAM therapy for families seeking treatment at a high-volume urban cleft center. A retrospective study of all patients undergoing primary cleft repair between 2012 and 2020 was performed. Patients were grouped based on whether or not NAM therapy was offered. Variables including physical, psychosocial, and financial factors were assessed. Two hundred and thirty patients underwent primary cleft repair between 2012 and 2020. Of these, 176 patients were indicated for NAM, with 4% discontinuing, and 54 patients did not undergo NAM. The 169 patients who completed NAM had a mean duration of treatment of 13.6±8.8 wks consisting of 15±6 scheduled NAM adjustment visits and 1±1 unscheduled visit made urgently to assess caregiver concerns. The mean travel distance was 28.6±37.1 miles. Eighty-four percent of caregivers were married, and 16% did not have English as a primary language. Though 57% had private insurance, 43% of patients received charity support for their treatment. NAM is a finite presurgical intervention that requires caregivers to participate in patient care for approximately three months of their early life. The decision to pursue NAM should be considered alongside the burden of care for caregivers to complete treatment.
PMID: 38231199
ISSN: 1536-3732
CID: 5737472
Predictors of Long-Term Protraction Headgear Success in Patients With Cleft Lip and Palate: A 5-Year Follow-Up
Schechter, Jill; Alcon, Andre; Verzella, Alexandra; Diaz, Allison; Staffenberg, David; Flores, Roberto; Shetye, Pradip R
Patients with cleft lip and palate (CLP) characteristically present with maxillary hypoplasia and class III malocclusion. Protraction headgear (PHG) is a commonly used treatment for this type of malocclusion, with the goal of reducing future surgical needs. The purpose of this study was to evaluate the long-term effects of PHG treatment and determine the pretreatment predictors of long-term PHG success in patients with CLP. Twenty-nine patients with CLP who had undergone PHG treatment from 2012 to 2017 at a single institution were retrospectively analyzed. Patients were included if they had a lateral cephalogram or CBCT before, immediately after, and at least 5 years after their PHG treatment. Patients were divided into surgery and nonsurgery groups based on their 5-year follow-up clinical presentation. Student t tests, Wilcoxon signed-rank test, and a multivariate logistic regression model were used to compare pretreatment and post-treatment changes in both groups. Immediately post-treatment, the maxilla advanced 2.6 mm, the maxillary dentition advanced 4.7 mm, and the mandible rotated downward 5.0 mm and backward 2.6 mm. At long-term follow up the maxilla advanced 0.0 mm while the mandible advanced an additional 7.5 mm. Thus, PHG treatment is effective at improving class III malocclusion in the short term, but may not prevent future surgical need for patients with more severe skeletal discrepancies. Variables predictive of future surgical need include ANB, anterior facial height, overjet, and starting age of treatment, with ANB as the most reliable early predictor.
PMID: 39190786
ISSN: 1536-3732
CID: 5729672
Comparison of the Effects of Postoperative Arm Restraints and Mittens on Cleft Lip Scar Quality after Primary Repair
Verzella, Alexandra N; Laspro, Matteo; Diaz, Allison; Cassidy, Michael F; Park, Jenn; Schechter, Jill; Alcon, Andre; Shetye, Pradip R; Staffenberg, David A; Flores, Roberto L
PMCID:11242569
PMID: 38999195
ISSN: 2077-0383
CID: 5732512