Evaluation of Entire Papilla Preservation Technique in Combination With Enamel Matrix Derivative & Bone Mineral Derived Xenograft in Isolated Interdental Intrabony Defects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- relative attachment level gain
研究概览
简要总结
The present three-arm study compared the clinical and tomographic efficacy of the Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derivedxenograph (BMDX), in the treatment of isolated, inter-dental intra-bony defects.
详细描述
This randomized controlled clinical and tomographic study included 48 sites with isolated interdental intrabony defects, divided into three groups. Group 1 (control) received EPPT alone, Group 2 received EPPT with EMD, and Group 3 received EPPT with EMD and BMDX (Fix-Oss xenograft). Clinical parameters probing pocket depth (PPD), relative attachment level (RAL), gingival recession (GR), and papilla height-were recorded at baseline and 12 months. Cone-beam computed tomography (CBCT) was used to evaluate tomographic changes including defect width, CEJ-BD, CEJ-AC, X-ray INFRA and defect angle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •stage II or III periodontitis, according to WWP 2017 classification of periodontal diseases in need of periodontal regenerative treatment for isolated intrabony defects
- •single-rooted teeth/multi-rooted teeth without furcation involvement
排除标准
- •uncontrolled or poorly controlled diabetes,
- •unstable or life-threatening conditions, or requiring antibiotic prophylaxis,
- •History of use of medications since last 6 months (immunosuppressants and antibiotics),
- •Subjects allergic to medications,
- •Pregnant or lactating women, Smokers/users of other tobacco products,
- •Subjects showing unacceptable oral hygiene maintenance after initial phase I therapy and
- •multiple interconnected vertical defects.
研究组 & 干预措施
Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft
Entire Papilla Preservation Technique with Emdogain and Bovine Derived Xenograft
干预措施: Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) (Procedure)
Entire Papilla Preservation Technique
Entire Papilla Preservation Technique alone
干预措施: Entire Papilla Preservation Technique (Procedure)
Entire Papilla Preservation Technique with Emdogain
Entire Papilla Preservation Technique with Emdogain
干预措施: Entire Papilla Preservation Surgical Technique (EPPT) alone (Procedure)
结局指标
主要结局
relative attachment level gain
时间窗: 6 months
measuring relative attachment level gain with UNC-15 probe
pocket depth change
时间窗: 6 months
measuring probing pocket depth changes
次要结局
- Tomographic defect width(6 months)
- the distance between the cemento-enamel junction and the bottom of the defect(6 months)
研究者
Karthik Krishna M
Principal Investigator
Rungta College of Dental Sciences and Research