Comparative Evaluation of Platelet-Rich Fibrin in Combination with NovaBone® and NovaBone® Alone in Treatment of Periodontal Intrabony Defects by RVG and CBCT : A Clinicoradiographic Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in intrabony defect (seen by advanced radiography i.e. RVG & CBCT) within 3 to 6 months
研究概览
简要总结
This study is a Randomized, parallel group, active controlled clinical trial comparing the efficacy of glass based alloplastic bone graft material alone and combination of glass based alloplastic bone graft material with autologus Pltelet Rich Fibrin in 20 patients with chronic periodontitis exhibiting at least a pair of intrabony defects (20 sites for each group) followed by re-evaluation at 3 and 6 months.
The primary outcome measures will be improvement in patient’s periodontal status (reduced probing pocket depth, gain in clinical attachment level, and bone fill at periodontal intrabony defects.
The secondary outcomes will be reduction in patient’s plaque & gingival bleeding scores.
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, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with moderate to advanced periodontitis as assessed by probing pocket depth ≥ 5 mm and clinical attachment level ≥ 5 mm
- •Patients with atleast one pair of bilateral periodontal intrabony defect in either maxillary or mandibular arch.
排除标准
- •Subjects with history of systemic diseases, allergies or drug usage.
- •Subjects who have undergone periodontal treatment in previous 6 months.
结局指标
主要结局
Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in intrabony defect (seen by advanced radiography i.e. RVG & CBCT) within 3 to 6 months
时间窗: baseline, 6 weeks, 3 months, 6months
次要结局
- Reduction in Plaque scores and Gingival Bleeding scores representing improvement in Gingival (soft tissue) status, within 3-6 months.(baseline, 6 weeks, 3 months, 6months)