Results of Soft Tissue Grafting Around Implant in the Mandible Molar Area
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Hanoi Medical University
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in peri-implant soft tissue thickness
概览
简要总结
This randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients requiring implant treatment with insufficient peri-implant soft tissue thickness will be randomly assigned to receive either CTG or a collagen matrix at the time of implant surgery.
The study aims to evaluate and compare changes in peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour over a 9-month follow-up period, as well as the occurrence of postoperative complications. The results of this study will help determine whether a collagen matrix can provide clinical outcomes comparable to those of connective tissue grafting for peri-implant soft tissue augmentation.
详细描述
This randomized controlled trial is designed to compare two approaches for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients with insufficient peri-implant soft tissue thickness will be enrolled and randomly allocated in a 1:1 ratio to receive either CTG or a collagen matrix at the time of implant surgery. Randomization will be performed using a block randomization method, and outcome assessment will be conducted by a blinded examiner.
Clinical and digital evaluations will be performed at predefined time points, including baseline and follow-up visits up to 9 months after surgery. Peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour changes will be assessed using standardized clinical measurements and digital workflows based on intraoral scanning and cone-beam computed tomography where indicated. Postoperative healing and adverse events will be monitored throughout the follow-up period.
The study is conducted at a single academic center and is intended to provide comparative clinical data on the effectiveness and safety of collagen matrix versus connective tissue grafting for peri-implant soft tissue augmentation.
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)
盲法说明
Outcome assessment is performed by an independent examiner who is blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years.
- •Patients requiring dental implant treatment in the mandibular molar region.
- •Presence of insufficient peri-implant soft tissue thickness (\< 2 mm).
- •Adequate general health to undergo minor oral surgery.
- •Ability and willingness to provide written informed consent and comply with study procedures.
排除标准
- •Systemic conditions or medications that may impair wound healing.
- •Heavy smoking (more than 10 cigarettes per day).
- •History of allergy or hypersensitivity to collagen-based materials.
- •Previous graft failure or complications at the intended implant site.
- •Loss of three or more adjacent teeth in the study area (excluding third molars).
研究组 & 干预措施
Connective Tissue Graft (CTG)
Peri-implant soft tissue augmentation using autogenous connective tissue graft.
干预措施: Connective Tissue Graft (Procedure)
Collagen Matrix
Peri-implant soft tissue augmentation using a collagen matrix.
干预措施: Collagen Matrix (Device)
结局指标
主要结局
Change in peri-implant soft tissue thickness
时间窗: Baseline (before surgery) to 9 months after surgery
Change in peri-implant soft tissue thickness measured using standardized digital methods.
次要结局
- Change in width of peri-implant keratinized tissue(Baseline to 9 months after surgery)
- Change in peri-implant marginal bone level(Baseline to 9 months after surgery)
- Peri-implant clinical indices(Up to 9 months after surgery)
研究者
DUC NGUYEN MINH
DDS
Hanoi Medical University