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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
"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
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
An Innovative Technique of Presurgical Lip, Alveolus, and Nose Approximation (PLANA) for Infants with Clefts
Shetye, Pradip R
The innovative technique of "presurgical lip, alveolus, and nose approximation" (PLANA) offers a new approach within the domain of presurgical infant orthopedics for infants born with cleft lip and palate. Presurgical lip, alveolus, and nose approximation introduces the utilization of the NoseAlign device in conjunction with medical adhesive tapes, designed to approximate and support displaced soft tissue nasolabial structures in patients with cleft, without an intraoral plate. The NoseAlign device, constructed from medical-grade silicone, consists of 2 tubular portions that fit into the nostrils, connected by a columella band. Notably, it also features a wave-shaped and curved horizontal lip band, resting on the upper lip, with elastic clasps for secure attachment to the face with medical adhesive tapes. Presurgical lip, alveolus, and nose approximation therapy employs the NoseAlign device to support the collapsed nasal alar rim and cartilage, the displaced columella, the deviated nasal septum, and the displaced nasal alar base. This innovative approach minimizes the need for frequent office visits, making it particularly suitable for patients residing at a distance from specialized cleft centers. The prefabricated NoseAlign device offers effective support to nasal structures, making it suitable for unilateral and bilateral clefts. Importantly, the absence of an intraoral plate ensures it does not interfere with feeding. Presurgical lip, alveolus, and nose approximation therapy, initiated as early as 1 to 2 weeks, leverages the plasticity of nasal soft tissue and cartilage to achieve the desired nasal form before primary surgery. Although presurgical lip, alveolus, and nose approximation therapy does have some limitations, particularly in cases of medially collapsed alveolar segments, its simplicity, universal applicability, and patient-friendliness make it a promising technique in the presurgical infant orthopedics field.
PMID: 38587370
ISSN: 1536-3732
CID: 5664692
"The Effects of Gingivoperiosteoplasty and Cleft Palate Repair on Facial Growth."
Park, Jenn J; Kalra, Aneesh; Parsaei, Yassmin; Rochlin, Danielle H; Verzella, Alexandra; Grayson, Barry H; Cutting, Court B; Shetye, Pradip R; Flores, Roberto L
PURPOSE/OBJECTIVE:Gingivoperiosteoplasty (GPP) can avoid secondary alveolar bone graft in up to 60% of patients. The effects of GPP on maxillary growth are a concern. However, palatoplasty can also negatively impact facial growth. This study quantifies the isolated effects of GPP and cleft palate repair on maxillary growth at the age of mixed dentition. METHODS:A single institution, retrospective study of all patients undergoing primary reconstruction for unilateral cleft lip and alveolus (CLA) or cleft lip and palate (CLP) was performed. Study patients had lateral cephalograms at age of mixed dentition. Patients were stratified into four groups: CLA with GPP (CLA+GPP), CLA without GPP (CLA-GPP), CLP with GPP (CLP+GPP), and CLP without GPP (CLP-GPP). Cephalometric measurements included: sella-nasion-point A (SNA), sella-nasion-point B (SNB), and A point-nasion-B point (ANB). Landmarks were compared between patient groups and to Eurocleft Center D data. RESULTS:110 patients met inclusion criteria: 7 CLA-GPP, 16 CLA+GPP, 24 CLP-GPP, and 63 CLP+GPP patients. There were no significant differences in SNA, SNB, and ANB between CLA+GPP and CLA-GPP, or between CLP+GPP and CLP-GPP groups. In patients who did not receive GPP, SNA was significantly lower in patients with a cleft palate compared to patients with an intact palate (p < 0.05). There were no significant differences in SNA or SNB of CLP-GPP or CLP+GPP groups when compared to Eurocleft data. CONCLUSION/CONCLUSIONS:When controlling for the effects of cleft palate repair, GPP does not appear to negatively affect midface growth at the age of mixed dentition.
PMID: 37184473
ISSN: 1529-4242
CID: 5544102
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
Clinical Outcomes of Bilateral Cleft Lip and Palate Repair with Nasoalveolar Molding and Gingivoperiosteoplasty to Facial Maturity
Rochlin, Danielle H; Park, Jenn; Parsaei, Yassmin; Kalra, Aneesh; Staffenberg, David A; Cutting, Court B; Grayson, Barry H; Shetye, Pradip R; Flores, Roberto L
BACKGROUND:The long-term effects of nasoalveolar molding (NAM) on patients with bilateral cleft lip and palate (BCLP) are unknown. The authors report clinical outcomes of facially mature patients with complete BCLP who underwent NAM and gingivoperiosteoplasty (GPP). METHODS:A single-institution retrospective study of nonsyndromic patients with complete BCLP who underwent NAM between 1991 and 2000 was performed. All study patients were followed to skeletal maturity, at which time a lateral cephalogram was obtained. The total number of cleft operations and cephalometric measures was compared with a previously published external cohort of patients with complete and incomplete BCLP in which a minority (16.7%) underwent presurgical orthopedics before cleft lip repair without GPP. RESULTS:Twenty-four patients with BCLP comprised the study cohort. All patients underwent GPP, 13 (54.2%) underwent alveolar bone graft, and nine (37.5%) required speech surgery. The median number of operations per patient was five (interquartile range, two), compared with eight (interquartile range, three) in the external cohort ( P < 0.001). Average age at the time of lateral cephalogram was 18.64 years (1.92). There was no significant difference between our cohort and the external cohort with respect to sella-nasion-point A angle (SNA) [73 degrees (6 degrees) versus 75 degrees (11 degrees); P = 0.186] or sella-nasion-point B angle (SNA) [78 degrees (6 degrees) versus 74 degrees (9 degrees); P = 0.574]. Median ANB (SNA - SNB) was -3 degrees (5 degrees) compared with -1 degree (7 degrees; P = 0.024). Twenty patients (83.3%) underwent orthognathic surgery. CONCLUSION:Patients with BCLP who underwent NAM and GPP had significantly fewer total cleft operations and mixed midface growth outcomes at facial maturity compared with patients who did not undergo this treatment protocol. CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, III.
PMID: 36943703
ISSN: 1529-4242
CID: 5590622
LeFort I Horizontal Osteotomy: Defining the Feasibility of the "High Osteotomy"
Verzella, Alexandra N; Alcon, Andre; Schechter, Jill; Shetye, Pradip R; Staffenberg, David A; Flores, Roberto L
OBJECTIVE:To define "high osteotomy" and determine the feasibility of performing this procedure. DESIGN/METHODS:Single institution, retrospective review. SETTING/METHODS:Academic tertiary referral hospital. PATIENTS, PARTICIPANTS/METHODS:34 skeletally mature, nonsyndromic patients with unilateral CLP who underwent Le Fort I osteotomy between 2013 and 2020. Patients with cone-beam computed tomography (CBCT) scans completed both pre- (T1) and post-operatively (T2) were included. Patients with bilateral clefts and rhinoplasty prior to post-operative imaging were excluded. INTERVENTIONS/METHODS:Single jaw one-piece Le Fort I advancement surgery. MAIN OUTCOME MEASURES/METHODS:Measurements of the superior ala and inferior turbinates were taken from the post-operative CBCT. RESULTS:The sample included 26 males and 8 females, 12 right- and 22 left-sided clefts. The inferior turbinates are above the superior alar crease at a rate of 73.53% and 76.48% on the cleft and non-cleft sides, respectively. One (2.9%) osteotomy cut was above the level of the cleft superior alar crease, and no cuts were above the level of the non-cleft superior ala. On average, the superior ala was 2.63 mm below the inferior turbinates. The average vertical distances from the superior alar crease and the inferior turbinates to the base of the non-cleft side pyriform aperture were 12.17 mm (95% CI 4.00-20.34) and 14.80 mm (95% CI 4.61-24.98), respectively. To complete a "high osteotomy," with 95% confidence, the cut should be 20.36 mm from the base of the pyriform aperture. CONCLUSIONS:A "high" osteotomy is not consistently possible due to the relationship between the superior alar crease and the inferior turbinate.
PMID: 37885216
ISSN: 1545-1569
CID: 5614352