NCT02325570
已完成
不适用
The Evaluation of the Clinical Effects of the KLOX BioPhotonic OraLum Gel With a LED Curing Lamp as an Adjunct to the Non-Surgical Treatment of Moderate to Severe Chronic Periodontitis
KLOX Technologies Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年11月最近更新:
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KLOX Technologies Inc.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events, Serious adverse events and incidents
概览
简要总结
Multicenter, prospective, interventional open case series study using a randomized split-mouth design in moderate to severe chronic periodontitis patients having half-mouth treated with the KLOX BioPhotonic OraLum gel with a LED curing lamp as an adjunct to conventional non-surgical periodontal treatment (SRP) versus SRP alone in the second (control) half-mouth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent form;
- •Male or female patients aged 18 years old and above;
- •Good general health, free of systemic diseases such as diabetes, arthritis, HIV infection or genetic disorder that could influence the outcome of the treatment;
- •Patient with clinically confirmed signs and symptoms of generalized moderate to severe chronic periodontitis (as defined according to International Classification of Periodontal Diseases, Armitage 1999);
- •Patient has had no periodontal treatment for the last year prior to the study;
- •Females of childbearing potential must not be pregnant nor lactating at study entry and agree to use an adequate contraceptive method during the study.
- •Inclusion Criteria Post Oral Hygiene Instructions (OHI):
- •Patient demonstrates sufficient plaque control as indicated by a plaque score \< 30% after hygiene period;
- •Patient has at least two sites in each quadrant with probing pocket depth (PPD) equal or more than 5 mm or equal or less than 7 mm.
排除标准
- •Patient with an existing aggressive periodontitis;
- •Presence of oral local mechanical factor(s) that could, in the opinion of the investigator, influence the outcome of the study;
- •Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed;
- •Soft or hard tissue tumours of the oral cavity;
- •Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with periodontal healing within the last three months prior to study entry and throughout the study duration;
- •Patient has participated in any other clinical study within 30 days prior to study entry and throughout the study duration;
- •Use of anticoagulants such as warfarin, clopidogrel, enoxaparin or high doses of aspirin (162 mg daily);
- •Regular use of chlorhexidine oral rinses / mouthwashes (Non-medicated, over the counter, mouthwashes are acceptable);
- •Patient with current alcohol abuse or actively consuming drugs (addiction); as it may interfere with patient's ability to comply with study procedures
- •Periodontal surgery planned during the study;
结局指标
主要结局
Adverse events, Serious adverse events and incidents
时间窗: 3 weeks
Number of patients with adverse events, serious adverse events and incidents
Ease of performing SRP and time required to perform SRP
时间窗: 2 weeks
次要结局
- Impact on tissues (Visual examination of tissues)(3 weeks)
- Pain (Visual Analog Scale)(2 weeks)
- Impact on bleeding (Use of Bleeding on Probing (BOP) results)(2 weeks)
- Impact on Plaque Index (PI)(2 weeks)
- Impact on Gingival index (GI)(2 weeks)
研究者
研究点 (1)
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