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Efficacy of Custom-Made Zirconia Sheet Versus Polytetrafluoroethylene as a Non-resorbable Barrier in Maxillary
Muhammad Ibrahim Sakr1, Ahmed Sobhy Salem2, Ayman Ahmed Yaseen3
1Lecturer of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology, Mansoura, Egypt.
Background:
While titanium-reinforced expanded polytetrafluoroethylene (Ti-ePTFE) represents the most widely used nonresorbable barrier for large alveolar defects in guided bone regeneration (GBR), custom-designed zirconia membranes present a viable alternative.
Purpose:
The purpose of this study was to compare the clinical and radiographic outcomes of custom-made zirconia membranes versus Ti-ePTFE membranes in maxillary alveolar ridge augmentation.
Study Design, Setting, Sample:
This was a, parallel-group, single-blind randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Egypt. The study included subjects with missing maxillary teeth and vertical (≤8 mm) or horizontal (≤6 mm) alveolar defects, while it excluded active periodontal disease, uncontrolled systemic disease, pregnancy, bisphosphonate therapy, and heavy smoking.
Predictor Variable:
The predictor variable was reconstructive technique (membrane material). Subjects were randomly assigned in a 1:1 ratio to the Zirconia group or the Ti-ePTFE group using computer-generated permuted-block randomization.
Main Outcome Variable(S):
Outcome variables were clinical (wound dehiscence, membrane exposure, and infection, evaluated monthly) and radiographic (net volumetric bone gain [mm3] and linear gain [vertical and horizontal, mm]) assessed by cone-beam computed tomography superimposition at 6 months.
Covariates:
The covariates were age, sex, baseline defect dimensions, and implant site distribution.
Analyses:
Statistical analysis used independent and paired t-tests for continuous variables; χ2 or Fisher's exact test for categorical variables, with the level of statistical significance set at P < .05.
Results:
Twenty-four subjects were randomized and analyzed using an intention-to-treat approach (mean age 34.00 ± 9.98 years; 15 [62.5%] females, 9 [37.5%] males). Two (8.3%) subjects were lost to follow-up (early dehiscence and infection). Net volumetric gain was 109.75 ± 39.66 mm3 (Zirconia) versus 82.60 ± 25.15 mm3 (Ti-ePTFE), P = .06. Net vertical gain was 2.10 ± 0.72 mm versus 2.72 ± 0.57 mm (P = .02). The mean horizontal gain was 3.08 ± 0.56 mm versus 3.34 ± 1.07 mm (P = .5). Wound dehiscence occurred in 2 (16.7%) subjects per cohort.
Conclusions And Relevance:
Custom-made zirconia membranes and Ti-ePTFE membranes are viable, precise, and efficient rigid barriers for GBR. Multicenter trials with longer follow-up is warranted.