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临床试验/NCT07701473
NCT07701473尚未招募不适用

Efficacy of a Novel Synthetic GBR Membrane (Inox Nanoksa G-Plus) for Horizontal Ridge Augmentation: A Case Series

Cairo University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
12
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

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.

详细描述

Alveolar ridge resorption following tooth loss frequently results in insufficient bone width or height for ideal dental implant placement, affecting more than 40% of patients seeking implant therapy. Guided Bone Regeneration (GBR) is a well-established surgical technique for reconstructing these deficient ridges using barrier membranes. However, existing membranes present significant limitations: non-resorbable expanded polytetrafluoroethylene (e-PTFE) membranes require a second surgery for removal and carry high exposure-related complication rates, while resorbable collagen membranes often lack adequate mechanical stability and degrade unpredictably, particularly in vertical or large horizontal defects.

The Inox Nanoksa G-Plus membrane is a novel, non-resorbable hybrid nano-ceramic material containing nano-carbon and nano-zirconia within a methacrylate-based high-performance polymer matrix. While the manufacturer claims high strength, wear resistance, and biocompatibility for prosthetic applications, and recent in vitro studies have characterized its mechanical properties, no published clinical study has evaluated its safety or efficacy as a barrier scaffold for GBR in human patients. This knowledge gap forms the basis for the present investigation.

This study is designed as a prospective, single-arm, interventional clinical trial conducted at the Department of Periodontics, Faculty of Dentistry, Cairo University. No randomization or comparator group is included, as this is an initial clinical evaluation of a novel device. All eligible and consenting participants will receive the same standardized intervention.

Study Population: Systemically healthy adult patients (ASA class I or II), aged 18 years or older, presenting with partial edentulism in the maxilla or mandible and requiring horizontal (residual ridge width < 5 mm) or vertical (residual ridge height < 8 mm above vital structures) ridge augmentation prior to dental implant placement. Key exclusions include untreated periodontitis, bisphosphonate therapy, heavy active smoking (>10 cigarettes/day), and pregnancy or lactation.

Intervention: Participants will undergo a single GBR procedure using the Inox Nanoksa G-Plus membrane. The standardized surgical protocol involves a mid-crestal incision with full-thickness flap elevation, cortical perforations to enhance vascularization, placement of a particulate bone graft to fill the defect, and trimming and adaptation of the membrane to extend 3-5 mm beyond the defect margins. The membrane will be secured with titanium micro-screws, and the flap will be closed primarily with a tension-free, double-layer suture technique to achieve complete membrane coverage. Post-operatively, participants will receive prophylactic antibiotics (5-7 days), analgesics, and chlorhexidine mouth rinses for 14 days. Sutures will be removed at 10-14 days.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Inox Nanoksa G-Plus Membrane (Device)

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.

干预措施: Particulate Bone Graft (Device)

结局指标

主要结局

Postoperative Pain

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hazem Ahmed

MD

Cairo University

研究点 (1)

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