Clinical Outcomes of Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects - a Prospective, Double Blind, Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Clinical attachment level change (CALC)
研究概览
简要总结
Papillae tunneling techniques (PTT) are a new approach toward regeneration of isolated intrabony defects. Compared to regular papillae preservation techniques, PTT rely on complete preservation of involved interdental papillae, providing optimal healing environment for periodontal wound. Surgical access is therefore gained either by vertical incision in vestibulum, or by short releasing incision on adjacent tooth. Interdental tissue is then carefully raised in a full thickness manner by tunneling instruments, root surface thoroughly cleaned by the ultrasound scaler or Gracey curettes and defect filled with the biomaterial of choice.
While the success and aesthetic results of non-incised papillae techniques are well documented, no paper so far compared clinical results of papillae preservation techniques with different biomaterials.
Therefore, the aim of our study is to compare gain of clinical attachment level (defined by sum of pocket probing depth and recession) to regular papillae preservation techniques, and to prove non-inferiority of Gel 40® (collagen matrix, loaded with micronized heterologous bone) to Gen-Os® (granulated cortico-cancellous heterologous bone mix).
Secondary objectives include analysis of aesthetic parameters - differences in recession and tip of the papillae location before and after the treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •periodontitis stage III/IV
- •at least one periodontal lesion with pocket probing depth > 5 mm, limited by 2 or more bone walls and intrabony component > 3 mm.
- •good oral hygiene with plaque index and sulcular bleeding index < 30%.
- •systemically healthy
- •smokers and non-smokers
排除标准
- •systemic diseases that contraindicate the treatment,
- •on medications that affects periodontal healing
- •pregnant or lactating women
- •one wall intrabony defects
- •defects that involve buccal and lingual side of the tooth
- •tooth with incorrect endodontic treatment or restoration
结局指标
主要结局
Clinical attachment level change (CALC)
时间窗: 6 and 12 months
To evaluate the clinical attachment level change (CALG) in reconstructive periodontal treatment of isolated intrabony defects, using papillae preservation techniques and different biomaterials (Gel 40®, Gen-Os®).
次要结局
- Wound closure (WC)(1 week)
- Tip of papillae(6 and 12 months)
