NCT03251001已完成不适用
Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- keratinized tissue width
研究概览
简要总结
The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)
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
All clinical parameters were evaluated by a calibrated examiner (intraclass correlation coefficient = 0.98) blind to test and control groups.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •absence or deficiency of keratinized tissue (< 1mm) in two homologous contralateral sites of inferior premolars
- •Miller Class I or II gingival recession
- •Absence of radiographic bone loss
- •Vital tooth or with adequate endodontic treatment
- •Root surfaces without caries
- •Good oral hygiene (plaque index < 20%)
排除标准
- •Allergic to penicillin
- •Presenting systemic disease that impede surgical procedure
- •Pregnancy
- •Intake of calcium channel blockers that cause gingival augmentation
研究组 & 干预措施
Control
Active Comparator
Sites receiving a free gingival graft
干预措施: Control (Procedure)
Device - Acellular dermal matrix
Experimental
Sites receiving acellular dermal matrix
干预措施: Acellular Dermal Matrix (Device)
结局指标
主要结局
keratinized tissue width
时间窗: 18 years
Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is \> 5mm.
次要结局
- Attachment level(18 years)
- Recession depth(18 years)
- Probing depth(18 years)
研究者
Carla Andreotti Damante
Associate professor
University of Sao Paulo
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Soft Tissue Graft Versus Acellular Dermal Matrix in Preservation of Buccal Plate of BoneComparative StudyNCT06229561Faculty of Dental Medicine for Girls12
招募中
不适用
Safety and Efficacy of Acellular Dermal Graft in Orbital Fracture RepairS02.3S02.83Condition 1: Inferior wall fracture of orbit. Condition 2: medial wall fracture of orbit.fracture of orbital floorFracture of medial orbital wallIRCT20220424054640N3Iran University of Medical Sciences10
已完成
不适用
The Safety of a Novel Acellular Dermal Template as Treatment for Burns and ScarsFull Thickness Skin DefectsNCT02164760Association of Dutch Burn Centres13
已完成
不适用
A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin DefectsFull Thickness Skin DefectsNCT02373566Association of Dutch Burn Centres11
已完成
4 期
The Comparison of Acellular Dermal Matrix Allograft (CenoDerm) and a Subepithelial Connective Tissue Graft for the Treatment of Gingival Recession.Gingival recession.Gingival recessionIRCT201305201760N23Vice Chancellor for Research and Technology, Babol University of Medical Sciences24