Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pain experience
研究概览
简要总结
This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years.
- •A minimum of 18 teeth, wisdom teeth excluded.
- •Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss >30%.
- •Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP.
- •Presence of at least three teeth per quadrant.
排除标准
- •Periodontal treatment in the last 3 years.
- •Antibiotic intake 6 months before • the screening visit.
- •Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Dia- betes).
结局指标
主要结局
Pain experience
时间窗: 14 days
pain experience will be measured 14 days after GTR procedure; when the dressing is removed. Participants have to fill a VAS score out about pain intensity on a scale from 0 to 10 (0 = no pain, 5 = moderate pain and 10 = worst imaginable pain) and the amount of pain medication taken will be recorded
次要结局
- Probing pocket depth(6 months)
- Attachment level(6 months)
研究者
Mahmoud Abu-Ta'a
Associate Professor
Arab American University (Palestine)