Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series

NCT07701473 | Not Yet Recruiting

• 1 other identifier: CU 7.7.2026
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alveolar Ridge Augmentation; Guided Bone Regeneration; Membranes, Artificial; Bone Transplantation; GBR Membrane; Synthetic Membrane; Inox Nanoksa G-Plus; Vertical Bone Defect; Dental Implant

Outcome Measures

Primary Outcomes (3)

• 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.

  Days 1, 3, and 7 post-surgery

• 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).

  Days 1, 3, and 7 post-surgery

• 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).

  Days 1, 3, and 7 post-surgery

Secondary Outcomes (5)

• Horizontal Bone Gain

  6 months post-GBR (T2) vs. Baseline (T0)

• Vertical Bone Gain

  6 months post-GBR (T2) vs. Baseline (T0)

• Membrane Exposure

  Throughout healing period (up to 6 months post-GBR)

• New Bone Density

  6 months post-GBR (T2) vs. Baseline (T0)

• Patient Satisfaction

  6 months post-GBR (T2)

Study Arms (1)

Nanoksa G-Plus GBR Group

EXPERIMENTAL

Participants with horizontal or vertical alveolar ridge deficiency undergo guided bone regeneration using the Inox Nanoksa G-Plus membrane in conjunction with a particulate bone graft. All participants receive the same standardized surgical protocol.

Device: Inox Nanoksa G-Plus Membrane; Device: Particulate Bone Graft

Interventions

Inox Nanoksa G-Plus Membrane DEVICE

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.

Nanoksa G-Plus GBR Group

Particulate Bone Graft DEVICE

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.

Nanoksa G-Plus GBR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Periodontics, Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 11553, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Hazem A Hazem Ahmed Elsayed

CONTACT

+201099751196; hazem.elsayed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The radiologist evaluating CBCT scans for bone gain and bone density will be blinded to the time point (baseline vs. 6-month follow-up) and to the study hypothesis.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: All participants receive the same GBR procedure using the Inox Nanoksa G-Plus membrane.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)