Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Radiographic and clinical analysis
研究概览
简要总结
The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal [MS], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological analysis. Qualitative information related to the patient's perception considering the treatment were collected.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients ASA I
- •patients requiring single tooth extraction in the site between #4 to #13
- •patients without enough bone volume for immediate implant placement.
排除标准
- •patients with general contraindications for implant surgery
- •pregnant or lactating women
- •patients with untreated periodontitis
- •bruxism or severe clenching
- •immunosuppressed
- •patients with a previous history of irradiation of the head and neck area
- •uncontrolled diabetes
- •heavy smoker (>10 cigarettes/day)
- •poor oral hygiene and low motivation
- •use of bisphosphonates
- •substance abuse such as alcohol or drugs and psychiatric disorders.
研究组 & 干预措施
Collagen
This group received a bone graft (xenograft) and had the socket covered with a collagen membrane, in order to protect the bone graft inserted and seal the socket.
干预措施: Socket preservation (Procedure)
Free gingival graft
This group received a bone graft (xenograft) biomaterial and had the socket covered with a free gingival graft material, in order to protect the bone graft inserted and seal the socket.
干预措施: Socket preservation (Procedure)
结局指标
主要结局
Radiographic and clinical analysis
时间窗: 6 months
Socket preservation with xenograft biomaterial and another one to seal it (FGG or collagen membrane). Radiographic analysis - PA (periapical x-rays) comparing groups and periods of the follow-up. It was performed descriptive comparative analysis. Clinical evaluation - bleeding on probing (dichotomic analysis), ISQ (torque achieved - Osstell), qualitative analysis (questionnaire with 8 questions), and subjective appraisal of the soft tissue healing (according to the period of evaluation).
次要结局
- Histological analysis - Gingiva(6 months)
研究者
Gustavo Fernandes, DDS, MSc, PhD
Clinical Lecturer
University of Michigan