A clinical and radiographic evaluation of eggshell hydroxyapatite with amniotic membrane versus bovine bone-derived xenograft with amniotic membrane in human periodontal intrabony defects – A randomized controlled clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome measures will be to evaluate the clinical parameters such as Probing pocket depth, Plaque index, Gingival index, Gingival Bleeding Index and Relative attachment level and radiographic changes in bone fill and density in patients with intrabony defects following treatment with eggshell-derived hydroxyapatite with amniotic membrane and bovine bone-derived xenograft with amniotic membrane in periodontal intrabony defects.
研究概览
简要总结
This study is a randomized controlled clinical trial to compare the clinical and radiographic efficacy of eggshell hydroxyapatite with amniotic membrane versus bovine bone-derived xenograft with amniotic membrane in the treatment of periodontal intrabony defects. The primary outcome measures will be to evaluate the clinical parameters such as Probing pocket depth, Plaque index, Gingival index, Gingival Bleeding Index and Relative attachment level and radiographic changes in bone fill and density in patients with intrabony defects following treatment with eggshell-derived hydroxyapatite with amniotic membrane and bovine bone-derived xenograft with amniotic membrane in periodontal intrabony defects. The secondary outcome will be patient comfort, improved oral hygiene status assessed using Plaque index, Gingival index, Gingival Bleeding Index , reduced mobility, increased clinical attachment level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.1.Patients between 25 to 55 years of age (Vani et.al., 2023) 2.Stage III or IV Periodontitis (2017 classification) 3 Probing depth (PD) greater than or equal to 6 mm 4.2 or 3 wall defects 5.Systemically healthy subjects 6.Subjects who have not received any periodontal treatment in the past six months 7.Subjects who have been informed about the study and has given consent.
排除标准
- •Teeth with pulpal/periapical involvement
- •Teeth with poor prognosis
- •Smokers and alcoholics
- •Pregnant/lactating women
- •Patients with known systemic diseases/conditions
- •Subjects unwilling to participate in the study.
结局指标
主要结局
The primary outcome measures will be to evaluate the clinical parameters such as Probing pocket depth, Plaque index, Gingival index, Gingival Bleeding Index and Relative attachment level and radiographic changes in bone fill and density in patients with intrabony defects following treatment with eggshell-derived hydroxyapatite with amniotic membrane and bovine bone-derived xenograft with amniotic membrane in periodontal intrabony defects.
时间窗: At 3 months and 6 months, patient will be recalled and assessed
次要结局
- The secondary outcome will be patient comfort, improved oral hygiene status assessed using Plaque index, Gingival index, Gingival Bleeding Index , reduced mobility, increased clinical attachment level.(At 3 months & 6 months, patient will be recalled & assessed)
研究者
Smrithi K
Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bangalore