Vertical and Horizontal Ridge Augmentation With Titanium-Reinforced Dense PTFE Versus Reinforced PTFE Mesh: A Prospective Comparative Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Vertical Bone Gain (VBG)
研究概览
简要总结
This prospective comparative clinical study evaluated vertical and horizontal bone gain after guided bone regeneration using titanium-reinforced dense PTFE (TiR-dPTFE) membranes versus reinforced PTFE mesh (RPM) in patients requiring ridge augmentation prior to implant placement. Radiographic outcomes were assessed using CBCT at baseline, 9 months, and 12 months. Histological evaluation was performed in selected cases. Healing events and complications were recorded.
详细描述
This prospective comparative case series investigated the clinical and radiographic performance of two non-resorbable barrier membranes used for guided bone regeneration (GBR): titanium-reinforced dense PTFE (TiR-dPTFE) and reinforced PTFE mesh (RPM).
Fourteen patients presenting alveolar ridge defects requiring vertical and/or horizontal augmentation prior to implant placement were consecutively enrolled. A total of 46 defect sites were treated using autogenous bone mixed with anorganic bovine bone mineral and covered with either TiR-dPTFE or RPM membranes.
Vertical bone gain (VBG) and horizontal bone gain (HBG) were measured on standardized CBCT cross-sections at baseline, 9 months, and 12 months. Histological evaluation of regenerated bone was performed in selected cases at re-entry. Adverse events and healing outcomes were recorded throughout follow-up.
The study aimed to compare dimensional bone regeneration outcomes and safety between the two GBR approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Partial or total edentulism requiring guided bone regeneration prior to implant placement
- •Presence of vertical alveolar bone defect >3 mm
- •Full-mouth plaque score <10%
- •Full-mouth bleeding on probing score <10%
- •Ability to understand study procedures and provide written informed consent
- •Provision of written informed consent prior to enrollment
排除标准
- •History of radiotherapy in the head and neck region
- •Alcoholism or substance abuse
- •Untreated or active periodontitis
- •Pregnancy or breastfeeding
- •Participation in another clinical trial within the previous 30 days
- •Medical or behavioral conditions that could interfere with study participation or outcome evaluation, including poor compliance or unreliability
研究组 & 干预措施
TiR-dPTFE membrane
Guided bone regeneration using titanium-reinforced dense PTFE membrane with autogenous bone and xenograft mixture.
干预措施: Titanium-reinforced dense PTFE membrane (TiR-dPTFE) (Device)
Reinforced PTFE mesh (RPM)
Guided bone regeneration using reinforced PTFE mesh with autogenous bone and xenograft mixture.
干预措施: Reinforced PTFE mesh (RPM) (Device)
结局指标
主要结局
Vertical Bone Gain (VBG)
时间窗: 9 months and 12 months after guided bone regeneration surgery
Vertical bone gain (mm) measured using standardized cone beam computed tomography (CBCT) cross-sectional images by comparing baseline measurements before guided bone regeneration with measurements obtained at follow-up. Measurements were performed using matched anatomical landmarks and calibrated digital image analysis software. Measurements were performed at the implant-site level with clustering within participants considered during statistical analysis.
次要结局
- Horizontal Bone Gain (HBG)(9 months and 12 months after guided bone regeneration surgery)
- Postoperative Healing Complications(From surgery to 12 months after guided bone regeneration)
- Histological Characteristics of Regenerated Bone(9 months after guided bone regeneration surgery)