Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Enamel Matrix Derivated and Xenograft for the Treatment of Periodontal Defects: A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recession (REC)
研究概览
简要总结
The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with periodontitis.
- •plaque index and bleeding index of < 30%.
- •periodontal lesions with pocket probing depth > 5 mm.
- •intrabony defect > 3 mm.
- •intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.
排除标准
- •patients with systemic diseases that contraindicated treatment.
- •third molars.
- •teeth with incorrect endodontic or restorative treatment.
研究组 & 干预措施
NIPSA
Patients will be treated with only NIPSA technique.
干预措施: NIPSA (Non-incised papilla surgical approach) (Procedure)
NIPSA plus Connective tissue graft
Patients will be treated with NIPSA technique associated to a connective tissue graft.
干预措施: NIPSA plus connective tissue graft (Procedure)
结局指标
主要结局
Recession (REC)
时间窗: 12 months
Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Location of the tip of the papillae (TP)
时间窗: 12 months
Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mmm.
Probing pocket depth (PD)
时间窗: 12 months
Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket.
Clinical attachment level (CAL)
时间窗: 12 months
Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.
Keratinized tissue width (KT)
时间窗: 12 months
Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
Bleeding on probing
时间窗: 12 months
Bleeding on probing could be positive or negative.
次要结局
未报告次要终点
研究者
Antonio José Ortiz Ruiz, MD
Professor and researcher
Universidad de Murcia