Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Facial Bone Dimensional Changes
研究概览
简要总结
This randomized clinical trial aims to compare two membrane materials used in Vestibular Socket Therapy (VST) technique during immediate implant placement in Type II extraction sockets in the esthetic zone.
A total of 30 patients will be randomly allocated to receive VST using either a biodegradable magnesium membrane or a cortical lamina membrane. Both groups will receive immediate implant placement and xenogeneic bone graft.
The study will compare changes in facial bone dimensions, soft tissue volume, implant stability, pink esthetic score, patient satisfaction, surgical time, and postoperative complications over a 6-month follow-up period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 45 years.
- •Requirement for extraction of one or more teeth in the maxillary esthetic zone with Type II extraction sockets.
- •Presence of adequate palatal and apical bone to achieve primary implant stability.
- •Adequate interocclusal restorative space for implant-supported prosthetic rehabilitation.
- •Good oral hygiene and satisfactory plaque control
排除标准
- •Acute infection at the intended implant site (e.g., acute abscess or cellulitis).
- •Uncontrolled systemic diseases or medical conditions that may compromise bone healing or osseointegration.
- •History of irradiation to the head and neck region within one year before implant placement.
- •Alcohol or drug abuse.
- •Pregnancy or lactation.
- •Parafunctional habits such as bruxism or clenching.
- •Current smoking or tobacco using.
- •Poor oral hygiene or inability to maintain adequate plaque control.
研究组 & 干预措施
Vestibular Socket Therapy Using Magnesium Membrane
Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
干预措施: Vestibular Socket Therapy Using Magnesium Membrane (Procedure)
Vestibular Socket Therapy Using Cortical Lamina
Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
干预措施: Vestibular Socket Therapy Using Cortical Lamina (Procedure)
结局指标
主要结局
Facial Bone Dimensional Changes
时间窗: Immediately after surgery (T0) and 6 months (T6)
CBCT scans obtained immediately after surgery (T0) and at six months (T6) will be superimposed using OnDemand3D software. The following parameters will be assessed: facial bone thickness at the crestal level, facial bone thickness at the middle level, facial bone thickness at the apical level, and facial bone height.
次要结局
- Soft Tissue Volumetric Changes(Baseline and 6 months postoperatively)
- Patient-reported Esthetic Satisfaction(6 months postoperatively)
- Surgical Time(During the surgical procedure)
- Postoperative Complications(1 week, 1 month, 3 months, and 6 months postoperatively)
- Implant Stability(Immediately postoperatively, 3, and 6 months postoperatively.)
- Pink Esthetic Score (PES)(6 months postoperatively.)
研究者
Dina Mohamed Hosam Eldin Zaghloul
Clinical Demonstrator, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University
Mansoura University