CLINICAL AND RADIOGRAPHIC EVALUATION OF ADVANCED-PLATELET RICH FIBRIN BLOCK WITH AND WITHOUT METRONIDAZOLE INFUSION COMPARED TO A MIXTURE OF A-PRF+ i-PRF ALONE IN THE MANAGEMENT OF PERIODONTAL INTRABONY DEFECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Defect fill (change in distance from cement enamel junction to Base of defect from baseline to 9 months) will be recorded
研究概览
简要总结
•Periodontitis is a polymicrobial disease where the inflammatory process results in progressive tissue destruction. The ultimate aim of periodontal therapy is to arrest the disease progression and to regenerate the lost tissues. Till date, several procedures have been developed in an attempt to regenerate the lost bone with the use of various bone graft materials, guided tissue regeneration, and/or the combination therapy with growth factors. Platelet rich fibrin (PRF) is the second generation autologous platelet concentrate introduced by Choukroun et al. in 2001. Various modifications of PRF clots have been introduced by reducing the speed and increasing time which exhibited promising outcome for the clinicians to perform research. Recently, a novel method of “PRF block†consisting of pieces of L PRF mixed with i-PRF and bone graft formed into a cohesive block was proposed. This block forms a volumetric matrix which can be used to fill various osseous defects. In A-PRF block, the cut membrane of the A-PRF acts as a biological matrix and promotes migration of osteoprogenitor cells to the centre of the graft. Demineralized Freeze-dried Bone Allograft (DFDBA) will be used in this study to prepare A-PRF block. Evaluation of the efficacy of antibiotic infusion in A-PRF block for the treatment of intraosseous defects has never been tried earlier. This study is designed to evaluate clinically and radiographically the effect of advanced-platelet rich fibrin block(A-PRF+i-PRF+DFDBA) with or without antibiotic-infusion compared to a mixture of A-PRF+ i-PRF alone in the management of periodontal intrabony defects
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients with chronic periodontitis 2.With a platelet count within normal limits 3.Presence of atleast one or two sites with probing pocket depth (PPD) of more than 6 mm 4.Three-walled defect with depth of more than 3 mm, as confirmed by cone beam computed tomography (CBCT).
排除标准
- •1.Pregnancy and lactation 2.Smokers and tobacco users 3.Hypertension 4.Diabetes 5.Any other systemic disorders which affect the outcome of the treatment • Patients who are unwilling to participate in the study.
结局指标
主要结局
Defect fill (change in distance from cement enamel junction to Base of defect from baseline to 9 months) will be recorded
时间窗: baseline and after 9 months
Defect resolution (change in distance from Alveolar Crest to base of defect from baseline to 9 months) will be recorded
时间窗: baseline and after 9 months
次要结局
- Plaque index(PI)(Gingival index (GI))
研究者
TRUSHA KISHORE PEDNEKAR
GOA DENTAL COLLEGE AND HOSPITAL