Assessment of Soft Tissue Healing Over Immediately Placed Implant Sealed With Platelets Rich Fibrin (Prf) Versus Cyanoacrylate Glue (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Mid crestal soft tissue thickness
研究概览
简要总结
The health of peri-implant soft tissues is one of the most important aspects necessary for the long-term survival of dental implants. The importance of the peri-implant mucosal region lies in the need to establish a tight seal that isolates the implant and the bone from the oral environment. Study objective is to clinically compare the soft tissue healing, height, and thickness over immediate implants placed in type I sockets sealed by PRF to those sealed by a Cyanoacrylate glue.
详细描述
the study will be conducted on 16 extraction sockets in humans. Sockets will be randomly divided into two groups: Group I (test) will comprise 8 sockets sealed by PRF after immediate implant placement. Group II: (test) will comprise 8 sockets sealed by cyanoacrylate glue after immediate 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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any non-restorable hopeless tooth; a badly decayed tooth that cannot be restored, a Tooth with failed endodontic treatment, and tooth with longitudinal fracture.
- •Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue graft
- •A good standard of oral hygiene.
- •No signs of active periodontal disease in the selected tooth.
排除标准
- •The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
- •The presence of Acute periapical infection.
- •The presence of any local factor that may interfere with extraction as tooth ankyloses. (
- •Subjects who had undergone therapeutical radiation. (38)
- •Patients who had been subjected to or who were under bisphosphonate therapy
结局指标
主要结局
Change in Mid crestal soft tissue thickness
时间窗: at baseline and after 4 weeks
Mid crestal soft tissue thickness over the immediate implant will be measured using a periodontal probe passing through soft tissue in the intersection midpoint of both buccolingual and mesiodistal dimensions of the socket till cover screw, after 4 weeks postoperatively
Change in soft tissue healing
时间窗: at 2nd week and 4th week
Soft tissue healing will be assessed in both groups in reference to the soft tissue healing index according to Landry index Landry index scores Very poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with loss of epithelium beyond incision marginSuppuration: Present Poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with connective tissue exposed Good: Tissue colour: ≥25% and\<50% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed Very good: Tissue colour: \<25% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed Excellent: Tissue color: All tissues pinkResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed
change in Mid-buccal soft tissue height
时间窗: at baseline and after 4 weeks
Mid-buccal soft tissue height: will be measured from gingival margin to implant platform, at surgery time and 4 weeks postoperatively
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University