Impact of Debridement Invasiveness on Attachment Gain After Antiinfective Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Clinical Attachment Loss
研究概览
简要总结
This study compared the gain of periodontal attachment after concomitant one-stage removal of bacterial biofilms and subgingival calculus with a two-stage procedure removing subgingival calculus 6 weeks after the initial removal of soft subgingival bacterial biofilms.
详细描述
The concomitant removal of subgingival calculus and soft bacterial biofilms in a one-stage procedure might impair periodontal healing in deep infrabony pockets due to the mechanical disruption of demineralized bone sections at the bottom of periodontal lesions. This randomized controlled clinical trial therefore aims at comparing the resulting attachment gain 6 months after one-stage antiinfective periodontal therapy comprising the concomitant subgingival removal of soft bacterial biofilms and calculus with a two-stage approach removing subgingival calculus only 6 weeks after the initial removal of soft subgingival bacterial biofilms.
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
- Single (Outcomes Assessor)
盲法说明
The examiner performing the assessment of periodontal attachment gain is not aware of the type of the preceding intervention therapy (one-stage vs. two-stage) provided to the patient.
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
- •presence of periodontal disease
- •minimum of 1 tooth with an infrabony periodontal lesion and pocket depth ≥ 6mm
- •minimum of 15 natural teeth
排除标准
- •systemic disease interfering with periodontal healing (e.g. diabetes)
- •antibiotic therapy ≤ 12 month prior to study participation
- •necessity for preventive antibiotic therapy during dental interventions
- •inability to comply with the study protocol
研究组 & 干预措施
Two-Stage Subgingival Debridement
Initially soft subgingival bacterial biofilms are removed from periodontal lesions by an airpolishing device and erythritol cleaning powder. 6 weeks later subgingival calculus is mechanically removed in a second step by mechanical scaling and root planing
干预措施: Subgingival Debridement (Procedure)
One-Stage Subgingival Debridement
Soft subgingival bacterial biofilms, as well as subgingival calculus are concomitantly removed from periodontal lesions by mechanical scaling and root planing
干预措施: Subgingival Debridement (Procedure)
结局指标
主要结局
Change in Clinical Attachment Loss
时间窗: 168 days (24 weeks)
Difference in millimeter (mm) in the distance between the cemento-enamel-junction and the probable bottom of the periodontal pocket recorded at baseline and at the end of the study in periodontal pockets with a baseline pocket depth ≥ 6 mm
次要结局
- Change in Bleeding on Probing(168 days (24 weeks))
- Change in Probing Pocket Depth(168 days (24 weeks))
- Change in Gingival Index (GI)(168 days (24 weeks))
- Change in Plaque Index(168 days (24 weeks))
研究者
Prof. Dr. Ulrich Schlagenhauf
Chairman Dept. of Periodontology
Wuerzburg University Hospital