NCT03917030撤回不适用
Treatment of Grade II Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Sites with no signs of inflammation
研究概览
简要总结
Teeth with furcation grade II defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade II defects with open flap debridement.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontal disease stage III or IV according to 2018 criteria
- •Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs
- •Competent to give consent
排除标准
- •Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
- •Present or past use of bisphosphonate treatment
- •Pregnant or nursing subjects
- •Patients classified as > class II according to ASA classification
- •Previous surgical therapy of included furcation defects
- •Inability to comprehend and respond to the quality of life questionnaire
- •Dental restorations or prosthesis involving the furcation area
- •Root fractures or suspected fractures/infractions
- •Caries lesions in the furcation area
- •No systemic antibiotic treatment within 3 months prior to intervention
结局指标
主要结局
Sites with no signs of inflammation
时间窗: 24 months after treatment
Proportion of sites without inflammation, defined as no BoP or PPD\>4mm following treatment
次要结局
- Radiographic changes(24 months after treatment)
- Changes in patient-reported quality of life (QoL)(Preoperatively compared to 12 months after treatment)
- Loss of clinical attachment level(24 months after treatment)
- Number of participants with caries lesions(24 months after treatment)
研究者
Anders Verket
Principal investigator
University of Oslo
研究点 (2)
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