OBJECTIVE: The objective of this study was to assess the efficacy of presurgical nasoalveolar molding (PNAM) on long-term nasal symmetry and shaping after primary cheiloplasty in patients with unilateral complete cleft lip/palate (UCL/P). DESIGN: This was a two-group, parallel, retrospective, randomized clinical trial. SETTING: The setting for this study was the Chang Gung Craniofacial Center in Taoyuan, Taiwan. PATIENTS: Patients were divided into one of the following two groups: infants with UCL/P who underwent PNAM (PNAMgroup, n = 42) and infants with UCL/P who did not undergo PNAM (non-PNAM group, n = 42). INTERVENTIONS: Interventions included PNAM and primary cheiloplasty without nasal cartilage dissection. MAIN OUTCOME MEASURES: In this study, 4- to 5-year postoperative full-face and submental oblique photographs were taken of all patients and scored from 1 to 5 points by 10 medical evaluators. The scores were statistically analyzed using repeated-measures analysis of variance, and P < .05 was considered to represent statistical significance. RESULTS: After 1 to 3 months of PNAM but before primary cheiloplasty, the displaced nasal and alveolar cartilage showed obvious improvement. However, the scores in the PNAM and non-PNAM groups at 4 to 5 years postoperatively were 66.62 ± 14.25 and 66.31 ± 15.08, respectively. There was no significant difference between the two groups ( F = 0.009, P = .923). CONCLUSION:PNAM as an early-stage adjunctive therapy for nasal deformity correction is beneficial before primary cheiloplasty, but it is insufficient to maintain long-term nostril symmetry after primary cheiloplasty without nasal cartilage dissection.
RCT Entities:
OBJECTIVE: The objective of this study was to assess the efficacy of presurgical nasoalveolar molding (PNAM) on long-term nasal symmetry and shaping after primary cheiloplasty in patients with unilateral complete cleft lip/palate (UCL/P). DESIGN: This was a two-group, parallel, retrospective, randomized clinical trial. SETTING: The setting for this study was the Chang Gung Craniofacial Center in Taoyuan, Taiwan. PATIENTS: Patients were divided into one of the following two groups: infants with UCL/P who underwent PNAM (PNAM group, n = 42) and infants with UCL/P who did not undergo PNAM (non-PNAM group, n = 42). INTERVENTIONS: Interventions included PNAM and primary cheiloplasty without nasal cartilage dissection. MAIN OUTCOME MEASURES: In this study, 4- to 5-year postoperative full-face and submental oblique photographs were taken of all patients and scored from 1 to 5 points by 10 medical evaluators. The scores were statistically analyzed using repeated-measures analysis of variance, and P < .05 was considered to represent statistical significance. RESULTS: After 1 to 3 months of PNAM but before primary cheiloplasty, the displaced nasal and alveolar cartilage showed obvious improvement. However, the scores in the PNAM and non-PNAM groups at 4 to 5 years postoperatively were 66.62 ± 14.25 and 66.31 ± 15.08, respectively. There was no significant difference between the two groups ( F = 0.009, P = .923). CONCLUSION:PNAM as an early-stage adjunctive therapy for nasal deformity correction is beneficial before primary cheiloplasty, but it is insufficient to maintain long-term nostril symmetry after primary cheiloplasty without nasal cartilage dissection.