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NOT YET RECRUITING
NCT07701473
NA

Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy of a Novel Synthetic GBR Membrane (Inox Nanoksa G-Plus) for Horizontal Ridge Augmentation: A Case Series

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-09-01

Completion Date

2027-09-01

Last Updated

2026-07-14

Healthy Volunteers

Yes

Interventions

DEVICE

Inox Nanoksa G-Plus Membrane

A sterile, non-resorbable hybrid nano-ceramic membrane composed of a methacrylate-based high-performance polymer matrix reinforced with nano-zirconia and nano-carbon. It is supplied as a pre-formed sheet (thickness \~0.2-0.3 mm) that can be cut and shaped intraoperatively. The membrane serves as a barrier scaffold to exclude soft tissue cells and allow osteogenic cells to populate the bone defect during guided bone regeneration.

DEVICE

Particulate Bone Graft

A commercially available particulate bone graft material (xenograft, allograft, or synthetic) selected based on defect type and surgeon preference. The graft is hydrated with sterile saline or autologous blood and packed into the defect to fill the volume and provide a scaffold for new bone formation.

Locations (1)

Department of Periodontics, Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt