Healing Following Use Of Injectable Platelet Rich Fibrin With Collagen During Surgery In Through And Through Periapical Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- change from baseline in periapical radiolucency at 12 months
研究概览
简要总结
Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery
详细描述
Detailed patient examination will be carried out and those satisfying inclusion criteria will be enrolled in the study. Written informed consent will be obtained and patients will be randomly allocated to two groups. Entire surgical procedure will be carried out by single operator. After complete elevation of the flap, debridement (periradicular curettage -enucleation) of the bony lesion will be performed. 3 mm root-tip resection will be performed and root end cavity will be prepared using an ultrasonic diamond-coated retrotip. Root end filling will be done with mineral trioxide aggregate (MTA). In test group The i-PRF will be produced and incorporated with collagen will be used to fill into the defect. In the control group, no guided tissue regeneration technique will be used. Flap will be re-positioned and sutured using nonabsorbable 4-0 silk sutures.Sutures will be removed 4-7 days postoperatively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of age 16-55 years with a clinical & radiographic diagnosis of through and through periradicular lesion using CBCT
- •Negative response to sensitivity tests with radiographic evidence of periapical radiolucency.
- •Failed previous root canal treatment primary or secondary with purulent discharge and radiographic evidence of periapical pathology.
- •The teeth must have adequate final restoration with no clinical evidence of coronal leakage.
排除标准
- •Unrestorable tooth.
- •Fractured / perforated tooth.
- •Systemic diseases contraindicating surgical procedures or with potential to affect healing.
- •Teeth with deep pockets.
- •Patient requiring antibiotic premedication.
- •Patients with history of antibiotic use in last 3 months.
结局指标
主要结局
change from baseline in periapical radiolucency at 12 months
时间窗: baseline to 12 months
2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 month with following scoring scores for 2D healing Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure) scores for 3D healing Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing
次要结局
- change in Quality of life from baseline to 7 days(postoperative Day 1 to day 7)