To evaluate the efficacy of NOVO graft as a bone regenerative material in the treatment of intraosseous periodontal defects: A clinical and CBCT analysis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Increase in the amount of bone fill in the periodontal 2 walled and 3 walled intraosseous defects
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of NOVO GRAFT, a demineralized freeze-dried bone allograft, in treating intraosseous periodontal defects. Thirty defect sites will be divided into a control group (open flap debridement alone) and an experimental group (open flap debridement with NOVO GRAFT). Clinical parameters such as probing pocket depth, relative attachment level, plaque index, and gingival index, along with radiographic bone fill assessed by CBCT, will be recorded at baseline and up to nine months. The study seeks to determine whether NOVO GRAFT enhances periodontal regeneration compared to conventional therapy.
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 and Investigator 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)Patients diagnosed as having chronic generalized periodontitis with periodontal pockets of more than or equal to 5 mm with radiographic evidence of vertical bone loss (2 walled and 3 walled defects) (2)Age group between 30 to 55 years (3)Patients with good general health without any history of systemic disease or medication.
排除标准
- •(1)Patients showing unacceptable oral hygiene during pre surgical (Phase I) period (2)Smokers (3)pregnant women and lactating mothers.
结局指标
主要结局
Increase in the amount of bone fill in the periodontal 2 walled and 3 walled intraosseous defects
时间窗: Baseline, 3 months, 6 months, 9 months
次要结局
- Decrease in probing pocket depth and increase in relative attachment level before and after treatment(Baseline, 3 months, 6 months, 9 months)
研究者
Dr Shalini Mishra
Hitkarini Dental College and Hospital