Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Postoperative Pain — Days 1, 3, and 7 post-surgery
  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.
• Postoperative Edema/Swelling — Days 1, 3, and 7 post-surgery
  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).
• Postoperative Bleeding — Days 1, 3, and 7 post-surgery
  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).

Trial sites (1)

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