Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this trial
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.
Eligibility criteria
Qualifiers
Partial edentulism in the maxilla or mandible requiring single or multiple implant-supported restorations.
Horizontal defect: residual ridge width < 5 mm at the intended implant site, OR
Vertical defect: residual ridge height < 8 mm above vital structures (mandibular canal, maxillary sinus, nasal floor).
Healthy oral mucosa with no signs of active infection or inflammation at the defect site.
Disqualifiers
Untreated periodontitis or active peri-implant disease.
Current or previous treatment with intravenous bisphosphonates (or oral bisphosphonates for > 3 years).
Severe immunosuppression or chronic systemic corticosteroid therapy (> 10 mg/day prednisolone for > 3 months).
Active smoking (> 10 cigarettes per day). Smoking cessation for at least 2 weeks before surgery is required; heavy smokers may be excluded.
Trial design
Treatments tested in this trial
- Inox Nanoksa G-Plus Membrane
- Particulate Bone Graft
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov