A RANDOMIZED CONTROL TRIAL TO DETERMINE THE BONE GAIN AFTER THE ALVEOLAR BONE REGENERATION USING RESORBABLE AND NON- RESORBABLE MEMBRANE AT EDENTULOUS SITE FOR IMPLANT PLACEMENT.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- to evaluate the horizontal bone gain using native collagen membrane with 1:1 mixture of autogenous particulate and anorganic bovine bone mineral (ABBM) vs using titanium mesh with the same mixture of bone particulate for GBR of horizontally deficient maxillary ridges with residual alveolar width ranging from 2 to 4 mm.
研究概览
简要总结
Dental implants have become one of the most sought procedures to restore missing teeth. Among the challenges that may hinder successful implant placement is the inadequate ridge volume. Many techniques have been discussed in literature to manage horizontal ridge deficiency including onlay block grafting, ridge splitting, and guided bone regeneration. Guided bone regeneration (GBR) has been successfully established in restoring horizontal bone deficiency in maxilla, which rely on preventing the soft tissue cells incorporation into the bone graft or the space created by the defect and allow only the osteogenic cells to be present, thus resulting in bone formation into this space. This is achieved by different barriers which can be resorbable or nonresorbable. Among resorbable barriers are collagen membranes, crosslinked or non-crosslinked, polyglygolic acid membranes and other types as reported in literature. Nonresorbable membranes include d-PTFE, e-PTFE, titanium foils, and titanium meshes. Different mixtures of particulate bone graft have been proposed in literature. These include an equal mixture of autogenous and anorganic bovine bone mineral which showed successful horizontal augmentation for guided bone regeneration with a non-crosslinked collagen membrane. The factors that enable successful guided bone regeneration with native collagen membrane include its biocompatibility, the rapid vascularization for the particulate graft necessary for its maturation and its elasticity allows for a higher volume of particulate graft. However, it cannot maintain the shape of the augmented defect without collapsing. On the other hand, titanium mesh can provide volumetric stability without being affected by the overlying muscle action despite the reported risk of wound dehiscence associated with titanium meshes.
Hence, the aim of the present study was to evaluate the horizontal bone gain as a primary outcome and histomophometric analysis of bone area percent as a secondary outcome using native collagen membrane with 1:1 mixture of autogenous particulate and anorganic bovine bone mineral (ABBM) vs using titanium mesh with the same mixture of bone particulate for GBR of horizontally deficient maxillary ridges with residual alveolar width ranging from 2 to 4 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Partial edentulism of maxilla or mandible with vertical and horizontal bone resorption of the alveolar ridge requiring three-dimensional bone regeneration for prosthetically guided implant placement.
排除标准
- •person smoking more than 10 cigarettes per day, pregmant women, person on daily medication,.
结局指标
主要结局
to evaluate the horizontal bone gain using native collagen membrane with 1:1 mixture of autogenous particulate and anorganic bovine bone mineral (ABBM) vs using titanium mesh with the same mixture of bone particulate for GBR of horizontally deficient maxillary ridges with residual alveolar width ranging from 2 to 4 mm.
时间窗: Baseline, 6 months after surgery and 6 months after implant placement.
次要结局
- to evaluate the histomophometric analysis of bone area percent using native collagen membrane with 1:1 mixture of autogenous particulate and anorganic bovine bone mineral (ABBM) vs using titanium mesh with the same mixture of bone particulate for GBR of horizontally deficient maxillary ridges with residual alveolar width ranging from 2 to 4 mm.(Baseline, 6 months after surgery and 6 months after implant placement)
研究者
Dr PRONOB SANYAL
Krishna Vishwa Vidhyapeet Deemed to be University. Karad
