Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- measure changes in periimplant mucosal thickness
研究概览
简要总结
The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with good systemic health with no contraindication for periodontal surgery.
- •No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
- •Ability to maintain good oral hygiene as evidenced in recall visits.
- •Aged 30 to 55 years.
- •Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (< 2mm bucco- lingual thickness).
排除标准
- •Medically compromised patients and systemic conditions precluding periodontal surgery.
- •Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure.
- •Patients subjected to irradiation in the head and neck area.
- •Patients treated or under treatment with intravenous amino bisphosphonates.
- •Patient affected by active periodontitis or has poor oral hygiene and motivation.
- •Uncontrolled diabetes mellitus.
- •Pregnant women or planning become pregnant, and nursing mothers.
研究组 & 干预措施
Autogenous Subepithelial Connective Tissue Graft plus dental implants
implant placement and augment Subepithelial Connective Tissue Graft and suture implant site
干预措施: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane (Procedure)
Amniotic Chorion Membrane plus dental implant
implant placement and augment Amniotic Chorion Membrane and suture implant site
干预措施: implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane (Procedure)
结局指标
主要结局
measure changes in periimplant mucosal thickness
时间窗: six months
The primary outcome of interest will be to measure changes (in mm) in horizontal periimplant mucosal thicknesson the buccal aspect of the edentulous alveolar ridge from baseline (BL) (implant placement and grafting) to (3 and 6 month) of post-surgical healing.
次要结局
- mid-buccal keratinized mucosal width(six month)
研究者
Mohamed Hamdy Helal
Lecturer of Oral Medicine, Periodontology, Oral Diagnosis & Radiology
Tanta University