Objectives: Quantitative assessment of 3-dimensional progressive changes of the maxillary geometry in unilateral cleft lip palate (UCLP) with and without nasoalveolar molding (NAM). Methods: The study was designed as a prospective 2-arm randomized controlled clinical trial conducted in parallel. Forty infants with nonsyndromic UCLP were randomly assigned into a NAM-treated group (n = 20) and non–NAM treated group (n = 20). A total of 120 laser-scanned maxillary casts were collected and blindly analyzed via a modified algorithm at T0 (initial visit; baseline), T1 (after 3 wk; first interval), and T2 (after 6 wk; second interval). The main outcome measures were the amount and rate of cleft gap changes, the midline position, and the transverse, sagittal, and vertical growth through intervals. Results: More than 50% of the cleft gap (56.42%; P < 0.001) was reduced in the first 3 wk of alveolar molding (AM). The end point of the AM was obtained in 6 wk (86.25%; P < 0.001); then, the kinks of the greater segment were noticed. The AM effect decreased as far as posterior; the anterior arch width reduced slightly (1.23%; P < 0.001), while the middle and posterior arches increased slightly (P > 0.999 and P = 0.288, respectively). The posterior arch width was the least changing and was considered a baseline, while the anterior was the pivot of the segment rotation. Both groups showed different patterns of segment rotation and sagittal growth. The non–NAM treated group showed a slight increase in cleft gap length, arch width, and midline position. Conclusion: Based on this study, it was concluded that the NAM treatment is effective in minimizing cleft severity and realigning maxillary segments without the deterioration of the transverse and vertical arch growth. Near follow-up visits are recommended to monitor the rapid gap reduction within the first 3 wk. Further trials are recommended to compare the outcomes regarding the sagittal growth to reference values ( ClinicalTrials.gov NCT03029195). Knowledge Transfer Statement: The results of this study will help clinicians understand nasoalveolar molding biomechanics that may improve the treatment outcomes for patients with unilateral cleft lip and palate. The trial data can be a valuable guide to the qualitative and quantitative predictive virtual molding in computer aided design–simulated nasoalveolar molding therapy. The modified algorithm can be used by researchers to quantify the rate, the sequence, and the direction of the maxillary segments movement in unilateral cleft lip and palate.
BACKGROUND
Skull base osteoradionecrosis (ORN) is a challenging treatment-related complication sometimes seen in patients with cancer. Although ORN management strategies for other anatomic sites have been reported, there is a paucity of data guiding the management of skull base ORN.
OBJECTIVE
To report a single-center tertiary care series of skull base ORN and to better understand the factors affecting ORN recurrence after surgical management.
METHODS
We conducted a retrospective cohort study of patients with skull base ORN treated at our center between 2003 and 2017. Univariate and multivariate binary logistic regressions were performed to identify predictors of recurrence.
RESULTS
A total of 31 patients were included in this study. The median age at ORN diagnosis was 61.1 yr (range, 32.8-84.9 yr). Of these 31 patients, 15 (48.4%) patients were initially treated medically. All 31 patients underwent surgery. Three (14.3%) of 21 patients treated with a free flap and 4 (50.0%) of 8 patients who underwent primary closure experienced recurrence. Cox regression analysis revealed that reconstruction with local tissue closure (P = .044) and ongoing treatment for active primary cancer (P = .022) were significant predictors of recurrence. The median overall survival from index surgery for ORN treatment was 83.9 mo. At 12-mo follow-up, 78.5% of patients were alive.
CONCLUSION
In this study, we assess the outcomes of our treatment approach, surgical debridement with vascularized reconstruction, on recurrence-free survival in patients with skull base ORN. Further studies with larger cohorts are needed to assess current treatment paradigms.
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