Biologically Oriented Alveolar Ridge Preservation using Demineralized Freeze Dried Bone Allograft(DFDBA)With Albumin-Platelet Rich Fibrin Biofiller Compared To DFDBA And Blood Clot Alone In Extraction Socket Preservation-A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Bone dimensional changes (bone height, bone width and bone mineral density) between the three groups as assessed by CBCT is set as the primary outcome
研究概览
简要总结
Alveolar bone resorption that occurs after tooth loss yields diminished alveolar ridge dimensions.Alveolar ridge preservation(ARP)) aids the surgeon in achieving optimal placement of implant with desired implant diameter while maintaining the aesthetics of overlying tissues.Studies have revealed that grafting of the alveolus results in persistence of residual graft particles embedded into the newly formed bone delaying the rate of bone deposition and mineralization.To overcome this a simplified,novel technique was introduced,namely, Biologically Oriented Alveolar Ridge Preservation(BARP) for ARP that restricts socket grafting to the coronal portion of the socket.
Albumin-Platelet rich fibrin(Alb-PRF) is prepared by mixing Heat treated platelet poor plasma(albumin gel)and the buffy coat layer(liquid PRF).This combination allows lower resorption properties of albumin gel along with higher cellular and growth factor content of the liquid PRF layer to be remixed.DFDBA has been shown to have osteoinductive potential and produce more vital bone.To our knowledge,no study has been conducted comparing the clinical efficacy of Biologically oriented alveolar ridge preservation (BARP) using DFDBA with Albumin-Platelet rich fibrin(Alb-PRF) biofiller ,DFDBA alone and naturally healing extraction socket with blood clot alone in extraction socket preservation.Hence this study is designed with the aim to evaluate and compare the efficacy of BARP using DFDBA with Alb-PRF biofiller, DFDBA alone and naturally healing extraction socket with blood clot alone in preserving alveolar ridge dimensions after tooth extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects of age 19-45yrs.
- •ASA(American Society Of Anaesthetologists) Physical status
- •Hopeless or non-restorable single tooth indicated for extraction and future implant placement.
- •Type 1 extraction socket with buccal plate measuring greater than or equal to 1 mm and less than or equal to 3 mm in thickness, with adjacent teeth in periodontal health.
排除标准
- •Subjects with compromised medical conditions contraindicating the surgical procedures.
- •Subjects taking medication influencing the bone metabolism and bone healing.
- •Subjects with the habit of smoking.
- •Subjects with known metabolic disorders.
- •Subjects in which tooth is extracted due to periodontal breakdown.
- •Subjects with acute infection ( or presence of pus) in or close to the site intended for extraction.
- •Pregnant and Lactating mothers.
- •Subjects with poor oral hygiene.
- •Subjects who are allergic to any of the materials used in the study.
结局指标
主要结局
Bone dimensional changes (bone height, bone width and bone mineral density) between the three groups as assessed by CBCT is set as the primary outcome
时间窗: Bone dimensional changes (bone height, bone width and bone mineral density) from baseline to 4 months post-operatively between the three groups as assessed by CBCT is set as the primary outcome.
次要结局
- 1.Soft tissue healing index [Landry R, Turnbull R and Howley T, 1988].(2.Buccolingual ridge width using bone calipers)