The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
研究概览
简要总结
To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums characterized by red, swollen, bleeding gums. And to determine if applying chlorhexidine via dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.
详细描述
Purpose of study: To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Trial design: The study will consist of a double-blinded, placebo-controlled parallel three-month clinical trial.
Randomization of subjects into study groups: Subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects.
Trial schedule:
- Screening for potential subjects & consent obtained. Calibration of examiner.
- Week -1: Professional prophylaxis consisting of scaling and polishing.
- Week 0: Baseline data (GI, SI, PI, BOP, PD) collected on subjects enrolled into the study. OHI - flossing. Subject randomized into a study group.
- Week 6: Subjects reassessed for GI, SI, PI, BOP, PD. Compliance check. Replenish floss supply. Subject concerns or questions addressed.
- Week 12: Subjects reassessed for GI, SI, PI, BOP, PD. All floss boxes and logbook returned. Subject concerns or questions addressed. Subject exited from study and returned to the care of his or her regular dental professional.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be considered for inclusion into the study, subjects must fulfill the following conditions:
- •18 years and older
- •Have gingivitis (i.e., have pocket depths of 4 mm or less), but not periodontitis
- •Willing to floss every day and have the necessary dexterity to floss
- •Have a minimum of 20 natural teeth, including 4 molars
- •Have at least 10 bleeding sites
- •Be a non-smoker
排除标准
- •Subjects will be excluded from the study, if they have any of the following conditions:
- •Pregnant or plan to be pregnant within the next 3 months
- •Allergic to chlorhexidine or quinine sulphate
- •Require pre-medication with antibiotics for dental treatment
- •Currently taking antibiotics
- •Currently taking Dilantin, Cyclosporin A, Nifedipine or other calcium channel blockers, aspirin or anti-coagulants
- •Currently using chlorhexidine or whitening products
- •Have active carious lesions
- •Have orthodontic braces
- •Have more than 2 crowns or bridges
- •Have more than 2 implants
- •Have full or partial dentures
- •Have periodontitis, i.e., pocket depths of 5 mm or more in more than 2 sites in the mouth
结局指标
主要结局
To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
时间窗: 3 months
次要结局
未报告次要终点