NCT01249846已完成3 期
The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to assess the efficacy and the safety of Chlorhexidine Gluconate Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of adult chronic periodontitis.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 patients aged >21 years old.
- •Availability for the 25 week duration of the study.
- •Chronic periodontal disease on natural teeth
- •Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.
排除标准
- •Oral health or factor that may influence the outcome of the study.
- •History of allergy to Chlorhexidine .
- •Patient uses Chlorhexidine oral rinses/mouthwashes on a regular basis.
- •Patients treated with medications that may influence the outcome of the study.
- •Presence of any of the following conditions: Type 1 diabetes, un-controlled type II diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
- •The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
- •Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
研究组 & 干预措施
Arm 1
Experimental
Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®.
干预措施: PerioChip ® (Drug)
Arm 2
Placebo Comparator
Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment.
干预措施: PerioChip ® (Drug)
研究者
研究点 (1)
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