Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Clinical attachment gain (CAG)
研究概览
简要总结
The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.
The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).
Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).
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
- •Stage III or IV periodontitis, including all grades.
- •Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
- •Interproximal plaque index <35% maintained during periodontal treatment and maintenance.
- •Adherence to periodontal maintenance appointments.
排除标准
- •Systemic disease contraindicating periodontal surgery.
- •Teeth with incorrect endodontic treatment or restoration.
- •Stage I or II periodontitis.
研究组 & 干预措施
Control
Access flap periodontal surgery
干预措施: periodontal surgery (Procedure)
Test
Access flap periodontal surgery and periodontal granulation tissue debridement.
干预措施: periodontal surgery (Procedure)
结局指标
主要结局
Clinical attachment gain (CAG)
时间窗: 12 months
Clinical attachment gain
次要结局
- PPDr(12 months)
- SUPRA-AG(12 months)
- rPD(12 months)
- iGR(12 months)
- Early Healing Index (EHI)(1 week)
研究者
Antonio José Ortiz Ruiz, MD
Professor and researcher
Universidad de Murcia