A Comparative Evaluation of Nonincised Papillae and Entire Papilla Preservation Surgical Approach in the Treatment of Intrabony Defects - a Clinical and Radiographic Study
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- CLINICAL ATTACHMENT LEVEL (CAL)
研究概览
简要总结
The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.
详细描述
Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession.
In order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
a randomized, triple-blinded, parallel study
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.
- •Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.
- •Adequate attached gingiva of 3mm and vestibular depth of 8mm. -
排除标准
- •Uncontrolled systemic disease.
- •Pregnancy and lactation.
- •Defects involving lingual sites.
- •Presence of restoration in the experimental teeth.
结局指标
主要结局
CLINICAL ATTACHMENT LEVEL (CAL)
时间窗: Baseline to 6 months
measured from the cemento-enamel junction (CEJ) to the bottom of the pocket
POCKET PROBING DEPTH (PPD)
时间窗: Baseline to 6 months
from the gingival margin to the bottom of the pocket;
Intrabony component (INTRA) of the defect
时间窗: Baseline to 6 months
the distance from the most coronal extension of the interdental bone crest (BC) to the bottom of the defect (BD) (BC-BD).
次要结局
- Papilla loss (PL)(Baseline to 6 months)
- Local bleeding score(Baseline to 6 months)
研究者
Dr R Viswa Chandra
Principal Investigator
SVS Institute of Dental Sciences