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Prominent Premaxilla in Bilateral Cleft Lip: A Blinded Expert-Panel Assessment of Orthopedic Response and Final Aesthetic Outcomes
Tanikawa, Daniela Y S; Chong, David K; Fisher, David M; Flores, Roberto L; Meazzini, Maria Costanza; Shetye, Pradip R; Figueroa, Álvaro A
BACKGROUND:A prominent premaxilla in bilateral cleft lip presents significant orthopedic and surgical challenges. Although presurgical infant orthopedics (PSIO) is widely used, evidence linking orthopedic response to clinically meaningful outcomes remains limited. This study evaluated orthopedic response, need for lip adhesion, and final aesthetic outcomes using blinded expert-panel assessments. METHODS:Fifty consecutive bilateral cleft patients treated with PSIO were reviewed, including 25 treated with nasal elevator and lip taping (NE) and 25 treated with Presurgical Lip-Alveolus-Nose Approximation (PLANA). Twenty-seven patients with prominent premaxilla underwent blinded assessment of orthopedic response by 3 cleft surgeons and 3 orthodontists. Final aesthetic outcomes were evaluated in a separate blinded assessment of 50 postoperative cases, mixing patients with and without prominent premaxilla to minimize recognition bias. RESULTS:The prevalence of prominent premaxilla was similar between groups (60.0% versus 48.0%; P=0.571). Lip adhesion was required more frequently in NE-treated than PLANA-treated patients (46.7% versus 8.3%; P=0.043). Patients treated with PLANA demonstrated superior orthopedic outcomes for premaxillary position, columellar length, and overall PSIO response (all P<0.001). Patients with prominent premaxilla achieved final nasal, lip, and overall nasolabial appearance ratings comparable to those without prominent premaxilla (all P>0.05). Evaluators showed poor ability to identify initially prominent premaxilla based on final appearance alone. Overall PSIO response correlated with final nasolabial appearance (ρ=0.48, P=0.024). CONCLUSIONS:Although a prominent premaxilla represents a more challenging initial deformity, it did not predict inferior final appearance. Better orthopedic response was associated with more favorable final aesthetic outcomes, supporting the clinical relevance of effective presurgical orthopedic correction.
PMID: 42690915
ISSN: 1536-3732
CID: 6071904
Comparative Analysis of Presurgical Lip, Alveolus, and Nose Approximation and Nasoalveolar Molding in Infants With Bilateral Cleft Lip
Singer, Andrea J; Rivera, Lucas R Perez; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
Presurgical lip, alveolus, and nose approximation (PLANA) is a form of presurgical infant orthopedics designed to reduce cleft severity without an intraoral molding plate. This study compared nasolabial outcomes and the burden of care in patients with a bilateral cleft treated with PLANA in relation to nasoalveolar molding (NAM). A single-institution retrospective review was conducted of all patients with bilateral cleft lip treated with NAM (2016-2019) or PLANA (2023-2025). Clinical data were collected, including treatment timing, number of visits, and number of unscheduled appointments. Anthropometric measurements for nasolabial angle (NLA), columella length, pronasale to subnasale distance, and alar base width at initiation and completion of therapy were collected. Paired-samples t tests were used for intragroup changes, and independent-samples t tests were used for intergroup comparisons. Across 24 patients (11 PLANA and 13 NAM), the PLANA cohort required fewer visits (6 versus 17, P<0.05) and unscheduled appointments (0 versus 1, P=0.01). Treatment initiation occurred earlier in the PLANA group (11 versus 35 d, P<0.05), as did the insertion of the nasal appliance or stent (19 versus 72 d, P<0.05). Primary surgery was performed earlier in the PLANA group (107 versus 150 d, P<0.05). Both groups exhibited improvements in NLA, columella length, and the pronasale-to-subnasale difference, with no intergroup differences. The PLANA group exhibited greater improvement in alar base width (3.3 versus 0.4 mm, P=0.01). Patients treated with PLANA exhibit favorable nasolabial outcomes, as well as reduced treatment durations, scheduled visits, unscheduled appointments, and overall burden of care.
PMID: 42607152
ISSN: 1536-3732
CID: 6071418
An Institutional Comparative Cost Analysis Between Nasoalveolar Molding and Presurgical Lip, Alveolus, and Nose Approximation
Perez Rivera, Lucas R; Kantar, Rami S; Rrushi, Vitorela; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
Presurgical lip, alveolus, and nose approximation (PLANA) is a novel presurgical infant orthopedics approach that has demonstrated early favorable nasolabial outcomes. However, its associated costs have not been evaluated. This study compared treatment costs between PLANA and nasoalveolar molding (NAM). A single-institution retrospective review of patients treated with NAM (2018-2019) and PLANA (2024-2025) was conducted. Patients were grouped by unilateral or bilateral involvement, and the average number of visits per cohort was calculated. Publicly available standardized payment values from the Centers for Medicare & Medicaid Services were used to approximate the costs of physician services and facility resources. Total costs were calculated from the sum of the costs for physician services, facilities, and medical supplies. Seventy-four patients were included, including 40 treated with NAM (unilateral 30 and bilateral 10), and 34 treated with PLANA (unilateral 24 and bilateral 10). For patients with a unilateral cleft, the average cost of NAM was $4362.37 (services: $1893.67, facilities: $2160.50, and supplies: $308.20), whereas the average cost of PLANA was $2791.94 (services: $752.61, facilities: $830.96, and supplies: $1208.37). Across patients with a bilateral cleft, the average cost of NAM was $4980.01 (services: $2178.93, facilities: $2492.88, and supplies: $308.20), whereas the average cost of PLANA was $3100.76 (services: $895.24, facilities: $997.15, and supplies: $1208.37). The cost of NAM is largely driven by physician services and facility expenses, whereas the cost of PLANA is primarily driven by medical supplies, offset by a reduced number of visits. These findings may inform cleft centers in their selection of presurgical orthopedic interventions and guide the development of standardized payment criteria.
PMID: 42546168
ISSN: 1536-3732
CID: 6070799
Presurgical Lip, Alveolus, and Nose Approximation Versus Nasoalveolar Molding: Cleft Severity and Anthropometric Outcomes
Perez Rivera, Lucas R; Ricke, Chloe; Flores, Roberto L; Shetye, Pradip R
Nasoalveolar molding (NAM) is an established form of presurgical infant orthopedics (PSIO), whereas presurgical lip, alveolus, and nose approximation (PLANA) is a novel approach. This study compared presurgical outcomes between infants with a unilateral cleft lip treated with PLANA and NAM using an objective method for assessment of cleft severity and PSIO outcomes. A single-institution retrospective review was conducted of all patients treated with NAM (2017-2019) and PLANA (2023-2025). Anthropometric measurements including columellar angle, nostril width ratio, and lateral subnasale displacement were collected at the initiation and completion of therapy, and predefined thresholds were used to classify patients by cleft severity (mild, moderate, severe, and very severe) and outcome (poor, good, and excellent). A total of 64 patients were identified, including 36 patients treated with NAM and 28 treated with PLANA. At baseline, the 2 cohorts exhibited similar distributions in cleft severity categories. At the completion of therapy, statistically significant differences were observed between NAM (27.8% mild, 52.8% moderate, 16.7% severe, and 2.8% very severe) and PLANA (67.9% mild, 28.6% moderate, 3.6% severe, 0.0% very severe). This translated to significant differences in PSIO outcomes between NAM (11.1% excellent, 55.6% good, and 33.3% poor) and PLANA (60.7% excellent, 35.7% good, and 3.6% poor). Numerically, the 2 cohorts were statistically similar at baseline, but after PSIO the PLANA cohort displayed more favorable anthropometrics and larger improvements in all 3 parameters. Using an objective method for evaluating cleft severity, patients treated with PLANA exhibited superior morphologic outcomes in comparison to NAM.
PMID: 42544928
ISSN: 1536-3732
CID: 6070790
Caregiver Experiences With Infant PLANA Therapy for Cleft Lip and/or Palate: A Cross-Sectional Survey Study
Ricke, Chloe; Perez Rivera, Lucas R; Staffenberg, David A; Flores, Roberto L; Shetye, Pradip R
ObjectiveTo evaluate caregiver experiences with presurgical lip, alveolus, and nose approximation (PLANA) therapy, including adherence, burden, support, and perceived effectiveness in infants with cleft lip and/or palate.DesignCross-sectional survey study using an anonymous, voluntary questionnaire administered via Research Electronic Data Capture. Descriptive statistics were used to summarize responses, and qualitative responses were analyzed for common themes.SettingSingle tertiary care academic institution.Patients, ParticipantsCaregivers of infants with cleft lip and/or palate undergoing PLANA therapy were identified through institutional records. Of 48 eligible caregivers, 23 unique responses were included.InterventionsPLANA therapy utilizing the NoseAlign device with concurrent lip taping, applied at home with periodic clinical follow-up.Main Outcome Measure(s)Caregiver-reported adherence, training satisfaction, infant tolerance, caregiver burden, perceived support, and perceived effectiveness.ResultsCaregivers reported high satisfaction with training (73.9% very satisfied) and high adherence, with 87.0% reporting consistent use and 100% reporting daily wear. Most reported no feeding interference (86.4%) and good infant tolerance (73.9% comfortable or very comfortable). Caregiver burden was low, with 60.9% reporting minimal impact on daily routines and 78.3% reporting confidence in application. Perceived support from the medical team was uniformly high (100%). Overall, 90.9% were satisfied with outcomes, and 95.7% would recommend PLANA therapy.ConclusionsPLANA therapy demonstrates high caregiver satisfaction, strong adherence, and favorable perceived outcomes. Its simplified design may reduce caregiver burden while maintaining effectiveness. Further studies are needed to evaluate long-term outcomes and cost-effectiveness.
PMID: 42360073
ISSN: 1545-1569
CID: 6056452
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
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