Comparison of Half- and Full-Grafting Alveolar Ridge Preservation With Different Sealing Materials: A Three-arm Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- bone dimensional changes between the groups
研究概览
简要总结
The aim of the present study was to compare the half-packed grafts that are covered with either a collagen or a nonresorbable membrane to the conventional alveolar ridge preservation procedures involving full-packed grafts and collagen membrane. The primary purpose was to evaluate the bone dimensional changes between the groups, and the secondary objective was to assess the potential contributing factors to clinical, radiographic and implant-related outcomes under different alveolar ridge preservation procedures.
详细描述
Regarding different surgical approaches in alveolar ridge preservation, limited studies directly compare collagen and non-resorbable membrane, and the comparison between half- and full- grafting strategy in clinical and radiographic outcomes was still lacking. The comparable effect of dimensional preservation between groups was shown except for more radiographic bone gain in full-grafting group. Contributing factors, including thin bone thickness , vertical root fracture related sockets, non-molar sites and large BPD might attenuate the effect of ARP. At implant placement, similar results in bone quality and keratinized mucosal width was found in all groups, while thicker vertical mucosal thickness was obtained when using nonresorbable membrane. All surgical modalities in alveolar ridge preservation yield stable peri-implant health 1 year after implant placement.
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, Investigator, Outcomes Assessor)
盲法说明
The operator (L.C.Y.) was blinded to the assignment and opened the envelope just before the alveolar ridge preservation procedures, while both the participants and the examiners (C.M.Y., P.Y.K.) remained completely blinded to the assignments in the study protocol.
入排标准
- 年龄范围
- 24 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 20 years old
- •presence of one or more hopeless teeth requiring extraction and subsequent implant placement due to reasons such as crack tooth, vertical root fracture, endodontic failure, unrestorable caries and severe periodontitis
- •the extraction socket should have more than two walls for ARP, which includes type I-II sockets (Palatal/ lingual defects were also included)
- •participants should have a stable periodontal condition or history of periodontitis that is well-controlled with good oral hygiene. The pocket depth of the adjacent tooth around the socket should be less than 3 mm as assessed with a periodontal probe (Hu-Friedy, Chicago, IL, USA).
排除标准
- •heavy smokers consuming more than half pack of cigarettes daily
- •women who were pregnant, lactating, or planning to be pregnant
- •history of psychiatric disorders
- •uncontrolled and complicated medical conditions that might hinder wound healing or bone metabolism, including poorly controlled diabetes, autoimmune disorders, receiving current radiotherapy in the head and neck regions, taking bisphosphonate and other antiresorptive agents.
研究组 & 干预措施
Test1
half- (bottom 50% of socket filled with gelatin sponge and the top 50% of the socket filled with deproteinized bovine bone mineral mixed with collagen (DBBM-C)) then covered with a collagen membrane in tooth sockets
干预措施: Alveolar ridge preservation (Procedure)
Test2
half- (bottom 50% of socket filled with gelatin sponge and the top 50% of the socket filled with deproteinized bovine bone mineral mixed with collagen (DBBM-C)) then covered with a nonresorbable membrane in tooth sockets
干预措施: Alveolar ridge preservation (Procedure)
Control
full-grafting (DBBM-C+ Collagen membrane) in tooth sockets
干预措施: Alveolar ridge preservation (Procedure)
结局指标
主要结局
bone dimensional changes between the groups
时间窗: 6-month healing period after alveolar ridge preservation
Based on CBCT images, horizontal measurements by using AVIZO software (version 7.0, FEI). The measurements were repeated twice at a 2-week interval, and mean values were used for the final analysis (width or height in millimeters, mm): * Buccal bone plate thickness (BT) at 1 mm, 3mm, 5mm apical to the crest * Horizontal ridge width (HRW) at 1 at 1 mm, 3mm, 5mm apical to the crest * The change of HRW at 1, 3, 5 mm apical to crest (T2-T1). Vertical measurements in cross-sectional images: * Buccal bone height (BH)(mm) * Palatal/lingual bone height (PH)(mm) * The discrepancy between buccal and palatal/lingual height.(mm) * Midcrestal height (Mid-H)(mm) * The change of BH, PH, and Mid-H between immediate post-operative and 6 months later. (T2-T1)(mm).
次要结局
- Clinical and implant related outcomes(6-month healing period after alveolar ridge preservation)
研究者
Choying Lin
assistent professor
Chang Gung Memorial Hospital