NCT03213210终止不适用
Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis
Sunstar Americas1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年11月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Probing Depth
研究概览
简要总结
Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has read and signed the Institutional Review Board approved consent form before treatment.
- •Subject must be age 21 or above.
- •Subject must be willing and able to follow study procedures and instructions.
- •Subject affected by moderate to severe peri-implant disease.
- •Treated chronic periodontitis and proper periodontal maintenance care.
- •Dental implant must meet the following criteria to be selected for the study:
- •Implant presenting Probing Depth ≥ 6 mm
- •Radiographic implant bone loss more than 25% of the implant length (Apex of the implant to implant platform) .
- •Peri implant bone defect being a buccal dehiscence and semicircular bone resorption to the middle of the implant body, buccal dehiscence and circular bone resorption with lingual bone plate intact or circular bone resorption with buccal and lingual bone plates intact
- •Single tooth implant restoration or implant supported fixed partial denture.
排除标准
- •Subjects participating (currently or within 30 days prior to enrollment) in other clinical trials involving therapeutic intervention (either medical or dental).
- •Subjects with poor oral hygiene as indicated by a score of greater than 50% on the O'Leary Plaque Index.
- •Subjects with a systemic condition, which would preclude periodontal treatment, including but not limited to uncontrolled diabetes.
- •Subjects with acute infectious lesions in the areas intended for treatment.
- •Subjects taking chronic (i.e., > 2 weeks), therapeutic doses of medications known to affect bone metabolism such as nonsteroidal anti-inflammatory drugs or bisphosphonates. Prophylactic aspirin (≤ 325 mg q.d.) for cardiovascular indications will be permitted in subjects.
- •Female subjects who are pregnant or lactating, or sexually-active female subjects who are of childbearing potential and are not using hormonal or barrier methods of birth control. (except for when a result of pregnancy test is negative)
- •Subjects who are on any chronic antibiotic or steroidal therapy.
- •Smoker using more than 10 cigarettes or equivalent per day.
- •Smoker using cigar, smokeless tobacco use or e-cigarette.
- •Subjects diagnosed with drug induced gingival hyperplasia (e.g. calcium channel blockers).
- •Subjects with radiographic evidence of pathology in other areas of the mouth besides implant area to be treated.
- •Implant mobility.
- •Subjects with parafunctional habits and not wearing bite guard.
研究组 & 干预措施
Device treatment
Other
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
干预措施: easy-graft CLASSIC (beta-Tricalcium Phosphate) (Device)
结局指标
主要结局
Change in Probing Depth
时间窗: Change from baseline at 12 months after the surgery
Distance of probe penetration from gingival margin to bottom of peri-implant pocket
Esthetic Satisfaction
时间窗: At 12 months after the surgery
To be assessed by examiner and subject using the Visual Analog Scales
次要结局
- Change of Marginal Bone Level(Change from baseline at 6 and 12 months after the surgery)
- Change in Width of Keratinized Tissue(Change from baseline at 6 and 12 months after the surgery)
- Change in Clinical Attachment Level(Change from baseline to at 6 and 12 months after the surgery)
研究者
研究点 (1)
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