Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.
研究概览
简要总结
The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.
详细描述
Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients, over 18 years old.
- •In need of removal of a maxillary or mandibular molar first or second molar.
- •The molars to be extracted had to be bordered by at least one tooth.
- •The molars had to have a presence of > 2 mm of keratinized gingiva and three intact bony walls.
- •A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
- •Only one extraction per patient was accepted.
排除标准
- •Acute periodontal or periapical infection.
- •Pregnancy or lactancy.
- •Smokers of more than 10 cigarettes per day.
- •Previous adverse reactions to the biomaterials used in the study.
- •Metabolic diseases affecting the mechanism of bone remodelling.
- •Medications or treatments taken in the last twelve months and known to affect bone "turnover".
- •Patients with poor plaque control -more than 20% (O'Leary, Drake, Naylor, 1972).
- •Patients with absence of periodontal health maintenance or postoperative recommendations compliance.
结局指标
主要结局
Evaluation of ridge dimensional changes following ridge preservation in molar sites comparing the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.
时间窗: 5 months
To evaluate dimensional changes, the initial (CBCT1) and 5 months (CBCT2) CBCT images were processed and superimposed with the use of a specialized software image Simplant® O\&O (Denstply Sirona, Charlotte, NC, USA). Measurements were expressed in millimeters (mm) and percentages showing changes in ridge width at 1mm, 3mm and 5mm from the bone crest. The height of the buccal, and lingual bone crest was assessed, as well as the heigh in the central are of the socket.
次要结局
- Evaluate the histologic composition of the regenerated areas after the use of freeze dried bone allograft (FDBA) or xenograft (DBBM), and a resorbable membrane.(5 months)
- Evaluate the influence of buccal or lingual bone thickness on bone ridge changes(5 months)
研究者
Desire Abellán Iñiguez
Principal investigator
Universitat Internacional de Catalunya