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Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series

NCT07701473 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

  • Alveolar Ridge Deficiency
  • Alveolar Bone Loss

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-03-01
Completion
2027-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701473 on ClinicalTrials.gov