A Comparative Evaluation of the Effectiveness of Anorganic Bone Matrix/Cell Binding Peptide PepGen P-15 with Open Flap Debridement (OFD) in the Treatment of Human Infrabony Defects- A Clinical and Radiographic Study
试验速览
- 阶段
- 1/2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary outcomes: Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in Periodontal Infrabony Defect (seen radiographically)
研究概览
简要总结
This study is a Randomized, parallel group, active controlled clinical trial comparing the efficacy of Open Flap Debridement (OFD) with placement of PepGen P-15 and OFD alone in 20 patients with chronic periodontitis exhibiting bilateral periodontal infrabony 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 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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Presence of at least 2 radiographically detectable interproximal osseous defects with a probing depth ≥5mm & clinical attachment loss ≥ 5mm following initial therapy.
- •The depth of the intraosseous component of the defect estimated as ≥3mm by clinical and radiographic means.
排除标准
- •Subjects with history of systemic diseases, allergies or drug usage.
- •Subjects who have undergone periodontal treatment in previous 6 months
- •Teeth exceeding class II mobility.
结局指标
主要结局
Primary outcomes: Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in Periodontal Infrabony Defect (seen radiographically)
时间窗: outcome will be assessed at 3 months and 6 months.
次要结局
- Reduction in Plaque scores and Gingival Bleeding scores representing improvement in Gingival (soft tissue) status(At 6 months)