Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series

Overview

The goal of this clinical study is to learn if the Inox Nanoksa G-Plus membrane works to rebuild bone in the upper or lower jaw (ridge augmentation) for adults who need dental implants but do not have enough bone width or height. It will also learn about the safety of this membrane and how patients feel after surgery. \- The main questions it aims to answer are: How much pain, swelling, and bleeding do participants experience during the first week after the bone-building surgery? How much new bone width and height does the membrane help grow, as measured on a 3D X-ray (CBCT) taken 6 months after surgery? What medical problems or side effects (such as the membrane becoming visible through the gums, infection, or graft loss) do participants experience? This is a single-treatment study; all participants will receive the same surgery using the Inox Nanoksa G-Plus membrane together with a bone graft material. Participants will: Have surgery to place the membrane and bone graft under their gums to rebuild their jawbone. Take antibiotics and pain relievers, and use a special mouth rinse for about 2 weeks after surgery. Rate their pain, swelling, and bleeding on simple scales on days 1, 3, and 7 after surgery. Return for a checkup at 1 month and have a follow-up 3D X-ray at 6 months. Undergo a second surgery at 6 months to have dental implants placed and to evaluate the newly formed bone.

Alveolar ridge resorption following tooth loss frequently results in insufficient bone width or height for ideal dental implant placement, affecting more than 40% of patients seeking implant therapy. Guided Bone Regeneration (GBR) is a well-established surgical technique for reconstructing these deficient ridges using barrier membranes. However, existing membranes present significant limitations: non-resorbable expanded polytetrafluoroethylene (e-PTFE) membranes require a second surgery for removal and carry high exposure-related complication rates, while resorbable collagen membranes often lack adequate mechanical stability and degrade unpredictably, particularly in vertical or large horizontal defects. The Inox Nanoksa G-Plus membrane is a novel, non-resorbable hybrid nano-ceramic material containing nano-carbon and nano-zirconia within a methacrylate-based high-performance polymer matrix. While the manufacturer claims high strength, wear resistance, and biocompatibility for prosthetic applications, and recent in vitro studies have characterized its mechanical properties, no published clinical study has evaluated its safety or efficacy as a barrier scaffold for GBR in human patients. This knowledge gap forms the basis for the present investigation. This study is designed as a prospective, single-arm, interventional clinical trial conducted at the Department of Periodontics, Faculty of Dentistry, Cairo University. No randomization or comparator group is included, as this is an initial clinical evaluation of a novel device. All eligible and consenting participants will receive the same standardized intervention. Study Population: Systemically healthy adult patients (ASA class I or II), aged 18 years or older, presenting with partial edentulism in the maxilla or mandible and requiring horizontal (residual ridge width \< 5 mm) or vertical (residual ridge height \< 8 mm above vital structures) ridge augmentation prior to dental implant placement. Key exclusions include untreated periodontitis, bisphosphonate therapy, heavy active smoking (\>10 cigarettes/day), and pregnancy or lactation. Intervention: Participants will undergo a single GBR procedure using the Inox Nanoksa G-Plus membrane. The standardized surgical protocol involves a mid-crestal incision with full-thickness flap elevation, cortical perforations to enhance vascularization, placement of a particulate bone graft to fill the defect, and trimming and adaptation of the membrane to extend 3-5 mm beyond the defect margins. The membrane will be secured with titanium micro-screws, and the flap will be closed primarily with a tension-free, double-layer suture technique to achieve complete membrane coverage. Post-operatively, participants will receive prophylactic antibiotics (5-7 days), analgesics, and chlorhexidine mouth rinses for 14 days. Sutures will be removed at 10-14 days. Study Assessments and Timeline: Participants will be followed for a total of 12 months after implant loading. The primary outcomes (patient-reported) include postoperative pain assessed via a Visual Analog Scale (VAS 0-10), as well as clinical grading of edema and bleeding, recorded on days 1, 3, and 7 post-surgery. Secondary outcomes are assessed clinically and radiographically: membrane exposure (scored 0-3 with descriptive details), infection, graft complications, and radiographic bone gain measured by Cone Beam Computed Tomography (CBCT) at 6 months post-GBR. Horizontal and vertical bone gains will be quantified in millimeters, and new bone density will be measured in Hounsfield Units (HU). At the 6-month re-entry surgery, the membrane and fixation screws will be removed, dental implants will be placed, and implant primary stability will be recorded. A final follow-up at 12 months after implant loading will evaluate implant survival and success. Data Management and Analysis: All data will be recorded in standardized case report forms and entered into a password-protected electronic database. Statistical analysis will be performed using Medcalc software. Continuous variables will be analyzed using paired t-tests or Wilcoxon signed-rank tests for pre- versus post-operative comparisons, and repeated measures ANOVA for multiple time points. Categorical data will be presented as frequencies and percentages. A p-value ≤ 0.05 will be considered statistically significant. The sample size of 12 participants was calculated to estimate the mean bone gain with adequate precision, accounting for an anticipated 20% dropout rate. Ethics and Dissemination: The study protocol has received ethical approval from the Research Ethics Committee of the Faculty of Oral and Dental Medicine, Cairo University. All participants will provide written informed consent in Arabic after receiving a full explanation of the procedures, benefits, risks, and alternative treatments. Participant confidentiality will be strictly maintained. The results of this study will be submitted for publication in a peer-reviewed dental journal and presented at academic conferences, regardless of the outcome direction, to contribute evidence on the clinical applicability of synthetic high-performance polymer membranes in bone regeneration.