Wound Healing After Different Types of Papilla Incision in Periodontal Reconstruction Surgery. a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bleeding on probing
研究概览
简要总结
Three types of papilla incision in periodontal reconstruction techniques will be compared.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with periodontal disease.
- •Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.
- •Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.
- •Plaque index and bleeding index less than 30%.
排除标准
- •Systemic disease that contraindicates periodontal surgery.
- •Pregnant women.
- •Third molars or teeth with incorrect endodontic or restorative treatment.
研究组 & 干预措施
Minimally invasive surgical technique
The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures.
干预措施: Minimally invasive surgical technique (Procedure)
Midline interproximal soft-tissue incision
Marginal approach by midline interproximal soft tissue incision and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.
干预措施: Midline interproximal soft-tissue incision (Procedure)
Marginal approach by palatal incision
A small incision in the palatal aspect and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.
干预措施: Marginal approach by palatal incision (Procedure)
结局指标
主要结局
Bleeding on probing
时间窗: 12 months
Bleeding on probing could be positive or negative
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.
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.
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.
次要结局
- Supra-alveolar attachment gain (SUPRA-AG)(12 months)
研究者
Antonio José Ortiz Ruiz, MD
Professor and researcher
Universidad de Murcia