Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Total root coverage measured with a periodontal probe in millimeters
研究概览
简要总结
This study will seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20).
详细描述
The treatment of gingival recessions associated with interproximal bone and gingival tissue deficiency, and also the absence of interdental papilla, are major challenges within the periodontics due to lacking predictability. However, an intervention in these cases is extremely important, since the presence of these defects is associated with aesthetic, phonetic, hypersensitivity and may be associated with other dental damages. This study will seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20). A split-mouth design will be used with both procedures performed at the same surgical time.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presenting at least two single-rooted teeth with Miller's Class III and IV recessions with Norland & Tarnow class I, II or III papilla deficiency
排除标准
- •History of periodontal surgery at the area on the last 12 months
- •Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
- •Diabetics
- •History of head and neck radiotherapy
- •Teeth without adjacent mesial and distal contact
- •Teeth with mobility
- •Malpositioned teeth
- •Teeth with endodontic treatment
- •Teeth without a visible cementoenamel junction
研究组 & 干预措施
Test group
Bone regeneration with autogenous bone + scaffold.
干预措施: Bone regeneration (Procedure)
Test group
Bone regeneration with autogenous bone + scaffold.
干预措施: Scaffold (Device)
Control group
Bone regeneration with autogenous bone + collagen membrane.
干预措施: Bone regeneration (Procedure)
Control group
Bone regeneration with autogenous bone + collagen membrane.
干预措施: Collagen membrane (Device)
结局指标
主要结局
Total root coverage measured with a periodontal probe in millimeters
时间窗: One year
Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
Total interdental papilla formation measured with a periodontal probe in mm
时间窗: One year
Ideal if the distance from dental contact point to interdental papilla top = 0 mm
次要结局
- Depth of probing measured with a periodontal probe in millimeters(One year)
- Clinical attachment level measured with a periodontal probe in millimeters(One year)
- Gingival bleeding index measured with a periodontal probe(One year)
- Radiographic bone formation measured digitally in millimeters(One year)
- Tomographic bone formation measured digitally in cubic millimeters(One year)
- Evaluation of pink aesthetics by professionals using the Pink Esthetic Score(One year)
- Patient's evaluation of aesthetics using a visual analogue scale(One year)
- Patient's evaluation of dental sensibility using a visual analogue scale(One year)
- Patient's evaluation of post-operatory pain using a visual analogue scale(1 month)
研究者
Vitor de Toledo Stuani
Principal investigator
University of Sao Paulo