Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Immediate Implant Placement in Type II Extraction Sockets: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bone Volumetric changes
研究概览
简要总结
This randomized controlled clinical trial evaluates the effectiveness of bioresorbable magnesium membranes compared to traditional cortical lamina in Vestibular Socket Therapy (VST) for immediate implant placement in Type II extraction sockets. The study utilizes Vestibular Socket Therapy (VST), a minimally invasive technique that involves a small incision and a subperiosteal tunnel to place a "bone shield" and graft without the need to raise a traditional flap.
The trial compares two distinct materials used as the regenerative barrier: the control group utilizes a cortical lamina, which is a rigid bone plate known for its stability and slow resorption rate. The experimental group receives a magnesium membrane, an emerging class of "bioresorbable metals" that provides mechanical stability similar to titanium while releasing ions that stimulate bone-building cells and promote blood vessel growth. The study involves 24 patients who are monitored from baseline to six months post-surgery.
The primary goal is to measure volumetric bone changes-specifically the thickness and height of the facial bone-using superimposed 3D scans (CBCT). Additionally, the protocol tracks secondary outcomes such as esthetic results via the Pink Esthetic Score, mucosal thickness, oral hygiene levels, patient-reported pain, and overall satisfaction with the restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single or multiple teeth with hopeless prognosis in maxillary anterior teeth with either type I or type II extraction sockets.
- •Deficient labial bone plate in width (type I) and height (type II) sockets.
- •Minimal of 3.0 mm basal bone present for immediate implant placement to achieve optimum primary stability.
排除标准
- •Current smokers.
- •Patients with debilitating systemic disease.
- •Patients who have undergone any sort of radiotherapy and chemotherapy in past 2 years.
- •Pregnant and Lactating females.
研究组 & 干预措施
Control Group
Immediate implant and VST using cortical lamina.
干预措施: Immediate implant and VST using cortical lamina. (Procedure)
Test Group
Immediate implant and VST using magnesium membrane.
干预措施: Immediate implant and VST using Magnesium membrane. (Procedure)
结局指标
主要结局
Bone Volumetric changes
时间窗: Baseline and 6-months post-operative.
Volumetric changes of the facial bone will be assessed using high-resolution Cone Beam Computed Tomography (CBCT) scans. Facial bone thickness will be measured as the horizontal distance in millimeters (mm) from the implant surface to the outer contour of the facial bone plate. Measurements will be recorded at three distinct vertical levels: at the crestal bone level, at half of the implant length and at the implant apex. Facial bone height will be measured as a line parallel to the implant long axis from the implant apex to the labial bone plate crest.
次要结局
- Peri-implant soft tissue esthetic outcome(6-months post-operative.)
- Peri-implant mucosal thickness(Baseline and 6-months post-operative.)
- Plaque Index (PI)(Baseline, 1 month, 3 months and 6 months.)
- Gingival Index (GI)(Baseline, 1 month, 3 months, and 6 months.)
- Post-surgical Pain(At 6, 12, and 24 hours post-operatively, then daily for 7 days.)
- Patient Satisfaction(6-months post-operative.)
研究者
Mohamed Adel Alfeky
B.D.S. Faculty of Oral and Dental Surgery, Misr University for Science and Technology
Misr University for Science and Technology