Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series (NCT07701473) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series
Egypt12 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Partial edentulism in the maxilla or mandible requiring single or multiple implant-supported restorations.
* Insufficient bone volume for standard implant placement, defined as:
* 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.
* Systemically healthy or with well-controlled medical conditions (American Society of Anesthesiologists - ASA class I or II).
Exclusion Criteria:
* 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.
* Pregnant or lactating women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.