NCT01040286已完成2 期
The Efficacy and Safety of Flurbiprofen Chip Versus Chlorhexidine Chip (Periochip®) in Therapy of Adult Chronic Periodontitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Mean Probing Pocket Depth reduction
研究概览
简要总结
The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis.
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
- Double (Participant, Investigator)
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
- •Signed and dated informed consent form
- •Good general health
- •Male or female subjects aged >21 years old
- •Availability for the 9 week duration of the study
- •Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 5-9 mm in depth (potential target teeth) demonstrating bleeding on probing without involving the apex of the tooth and confirmed by dental X-ray.
- •Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method (Oral or parenteral hormonal contraceptive; Intrauterine device; barrier and spermicide) of birth control during the study.
排除标准
- •An existing aggressive periodontitis.
- •Presence of oral local mechanical factors that could (in the opinion of the investigator) influence the outcome of the study.
- •Presence of orthodontic appliances, or any removable appliances, that impinge on the tissues being assessed.
- •Soft or hard tissue tumours of the oral cavity.
- •Presence of dental implant adjacent to target tooth.
- •Presence of more than 2 adjacent periodontal pockets on the same potential target tooth.
- •Periodontal pockets of more than 9 mm in depth, and/or with class 2 or 3 furcation involvement, on the potential target tooth.
- •Systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
- •History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
- •Subjects taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
- •Subjects treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration.
- •Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis, abscesses and related oral pathologies.
- •The presence of any medical or psychiatric condition that in the opinion of the investigator could affect the successful participation of the subject in the study.
- •Subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
- •Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.
研究组 & 干预措施
Flurbiprofen Chip
Experimental
干预措施: Flurbiprofen (Drug)
Chlorhexidine chip
Active Comparator
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Mean Probing Pocket Depth reduction
时间窗: 8 weeks
次要结局
- clinical attachment levels (CAL) and bleeding on probing (BOP)(8 weeks)
研究者
研究点 (1)
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