NL-OMON30137尚未招募不适用
A randomized, controlled clinical trial comparing treatment of buccal class II furcation defects in mandibular molars with a bovine derived xenograft (Tutodent® microchips [Tutogen, Neunkirchen am Brand, Germany]) in combination with a bovine derived collagen membrane (Tutodent® membrane [Tutogen, Neunkirchen am Brand, Germany] to treatment with a bovine derived xenograft (Tutodent® microchips [Tutogen, Neunkirchen am Brand, Germany]) alone. - Class II furcation treated with BDX plus collagen membrane or BDX alone
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Periodontitis patients, diagnosed with chronic periodontitis, having reached at least the first re-evaluation time point after the initial phase of periodontal therapy.
- •All patients will have buccal class II furcation involvement in mandibular first or second molars.
排除标准
- •Beside the threshold levels decided for FMPS (25%) and FMBS (25%), patients will not be included in this study, (1) if they are systemically not healthy (that is, having any systemic condition that precludes periodontal surgery, or that might compromise wound healing), (2) if not diagnosed with chronic periodontitis, (3) treated with antibiotics within 3 months prior to surgery, (4) current smokers, and (5) involved in any other clinical trial. On a site level, the selected lower first or second molars will have (1) mandibular buccal class II furcation involvement (HPD > 3 mm), (2) proximal bone levels at or above the fornix of the furcation, and (3) a zone of keratinized tissue of at least 2 mm adjacent to the furcation defect, in order to provide coverage of the furcation entrance during surgery. If, (4) a root canal treatment was performed, the selected tooth must be asymptomatic and the root canal treatment must be without technical remarks, and (5) such a root canal treatment must be completed at least six months before the selected tooth is enrolled in the study. Teeth will be excluded from the study, if (1) buccal restorations extend to the furcation area in a way that the margins of these restorations are less than 1 mm away from the entrance of the furcation, (2) they have in addition lingual class II furcation involvement (HPD > 3 mm), (3) they are non-vital and have posts or screw retentive devices, (4) they are non-vital and are not endodontically treated, (5) furcation class III involvement is revealed during surgery, or (6) they have enamel projections into the furcation defect not being removable during surgery.
研究者
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