Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Keratinized tissue width (KT)
研究概览
简要总结
This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.
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
- Quadruple (Participant, Care Provider, Investigator, 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.
结局指标
主要结局
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.
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
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 mm.
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.
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.
Bleeding on probing
时间窗: 12 months
Bleeding on probing could be positive or negative.
次要结局
- Wound closure (WC)(1 week)
- Supra-alveolar attachment gain (SUPRA-AG)(12 months)
研究者
Antonio José Ortiz Ruiz, MD
Professor and researcher
Universidad de Murcia