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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Inox Nanoksa G-Plus Membrane
DeviceA 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.
Particulate Bone Graft
DeviceA 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Nanoksa G-Plus GBR GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Postoperative Pain
Pain intensity measured using a Visual Analog Scale (VAS) where 0 = no pain and 10 = worst imaginable pain. Patients record pain at rest and during function.
Time frame
Days 1, 3, and 7 post-surgery2
Postoperative Edema/Swelling
Clinically graded by a blinded assessor using a 4-point scale: 0 = none, 1 = mild (localized, intraoral only), 2 = moderate (visible extraoral swelling, no functional impairment), 3 = severe (significant facial swelling with functional impairment).
Time frame
Days 1, 3, and 7 post-surgery3
Postoperative Bleeding
Clinically assessed at the surgical site using a 4-point scale: 0 = none, 1 = mild (oozing, stops spontaneously), 2 = moderate (requires gauze change or local pressure), 3 = severe (requires surgical intervention).
Time frame
Days 1, 3, and 7 post-surgerySecondary outcomes
1
Horizontal Bone Gain
Change in ridge width measured on CBCT at 6 months compared to baseline. Measured at 1 mm, 3 mm, and 5 mm apical to the ridge crest; the mean of these three measurements is used. Gain = (width at T2) - (width at T0).
Time frame
6 months post-GBR (T2) vs. Baseline (T0)2
Vertical Bone Gain
Change in ridge height measured on CBCT at 6 months compared to baseline. Measured from the crest to the most apical point of the defect in the center of the defect. Gain = (height at T2) - (height at T0).
Time frame
6 months post-GBR (T2) vs. Baseline (T0)3
Membrane Exposure
Visible exposure of the Nanoksa G-Plus membrane through the oral mucosa during healing. Scored as: 0 = none, 1 = pinpoint \< 2 mm no suppuration, 2 = partial 2-5 mm with/without mild inflammation, 3 = complete \> 5 mm OR any exposure with suppuration/infection/graft loss. Time of first exposure and management are also recorded.
Time frame
Throughout healing period (up to 6 months post-GBR)4
New Bone Density
Bone density measured by CBCT densitometry in Hounsfield Units (HU) at the augmented site at 6 months compared to baseline.
Time frame
6 months post-GBR (T2) vs. Baseline (T0)Sponsors and contacts
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Source ClinicalTrials.gov
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