Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tooth or tooth replacement survival
研究概览
简要总结
Periodontal regeneration can change tooth prognosis and represents an alternative to extraction in teeth compromised by severe intrabony defects. The aim of this study is to compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a population with attachment loss to or beyond the apex of the root in terms of professional, patient reported and economic outcomes.
详细描述
This was a single center 10-year randomized controlled clinical trial. 50 stage III or IV periodontitis subjects with a severely compromised tooth with attachment loss to or beyond the apex were randomized to PR or TER with either an implant or a tooth supported fixed partial denture. Subjects were kept on a strict periodontal supportive care regimen every 3 months and examined yearly. Survival, complication free survival, recurrence analysis, oral health related quality of life and patient reported outcomes analyses will be performed.
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
Independent examiner
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good general health
- •Non-smokers or smokers with less than 20/day
- •Good oral hygiene (FMPS<25%)
- •Good control of periodontitis (FMBS<25%)
- •Good compliance with treatment
- •Presence of generalised stage III or IV periodontitis
- •Radiographic bone loss to the apex or beyond the apex of the root at at least one interdental aspect
- •Presence of severe clinical attachment level loss (>10 mm)
- •Presence of clearly identifiable crest of bone in adjacent teeth
- •Lack of function due to hyper mobility
- •Vital or non-vital teeth
排除标准
- •Medical contraindication to elective surgery
- •Poor oral hygiene
- •Incomplete control of periodontitis in the dentition
- •Inadequate compliance
- •Inability to provide informed consent
结局指标
主要结局
Tooth or tooth replacement survival
时间窗: 10 year
Presence of functional and symptoms free tooth or tooth replacement
Occurrence and cost of management of recurrence
时间窗: 10-year
Recurrence analysis
Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)
时间窗: 10 years
14 validated questions, 5 point Liker scale, smaller scores represent better outcome (smaller impact on quality of life)
次要结局
- Clinical attachment level gain(10 years)
- Probing pocket depth(10 years)