Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Keratinized tissue width
研究概览
简要总结
Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.
详细描述
The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline & 6-months.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between 20-80 years of age
- •healthy with no conditions that could alter wound healing
- •requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
- •a tooth requiring extraction that is treatment planned for implant placement
- •willing to participate in the study and sign the informed consent
- •willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.
排除标准
- •systemic conditions which could alter wound healing
- •tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
- •severe local infection at extraction site
- •a tooth exhibiting severe resorption of buccal or lingual plates
- •absence of keratinized tissue buccal to the tooth to be extracted
- •severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.
研究组 & 干预措施
Control
Socket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing.
干预措施: Socket preservation control (Procedure)
Experimental
Socket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing.
干预措施: Socket preservation experimental (Procedure)
结局指标
主要结局
Keratinized tissue width
时间窗: 6 months
Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.
次要结局
- Keratinized tissue thickness(6 months)
- CEJ-FGM(6 months)
- Ridge Width(6 months)
- Cast ridge width(6 months)
- Cast ridge volume(6 months)
- Vestibular Depth(6 months)
- CEJ- Buccal crest(6 months)
- CBCT bone height(6 months)
- CBCT bone width(6 months)
研究者
Heather Hong
Principle Investigator
Harvard School of Dental Medicine