Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Rosenberg Score at Indicated Time Points
研究概览
简要总结
Medical center personnel were screened organoleptically for bad breath by 2 investigators using Rosenberg scale 0-5, and measurement of breath sample in portable gas chromatograph. With a threshold score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial of the mechanical effect of daily tongue scraping with the adjunctive use of 0.12% chlorhexidine gluconate mouthwash or 0.1% stabilized chlorine dioxide mouthwash. Subjects randomly assigned in double-blind trial for one week. The null hypothesis is there will be no difference between the two rinses as adjuncts to tongue scraping.
详细描述
Subjects in trial had oral and periodontal exam and scored the Ramfjord teeth(#3, 9, 12, 19, 25, 28) for Plaque Index(PlI), Gingival Index(GI), probing depth (PD), recession. A tongue coating index is scored and sample of coating on dorsum taken for culture of total viable count and percentage of black sulfide-producing colonies on anaerobe agar with lead acetate added. Subjects given hygiene instruction and instruction on use of scraper, then rinse with 20ml assigned mouthwash 30sec. Breath assessed by organoleptic means and mouth air sample concentration of hydrogen sulfide, methyl mercaptan in portable gas chromatograph at 0, 1, 2, and 4 hours. Subjects use scraper and mouthwash twice daily for one week and return for final exam.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult with threshold score of 2 on organoleptic halitosis evaluation
排除标准
- •Taking another experimental drug, or antibiotic.
研究组 & 干预措施
Chlorhexidine gluconate and scraper
The intervention was accomplished by subject after instructions from investigator: twice a day a tongue scraper was used with 4 or more strokes, followed by 20ml of 0.12% chlorhexidine gluconate mouthwash used for 30 sec, for one week.
干预措施: Chlorhexidine gluconate and scraper (Drug)
Chlorine dioxide and scraper
The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.1% stabilized chlor8ine dioxide rinse for 30sec, for one week.
干预措施: Chlorine dioxide and scraper (Drug)
结局指标
主要结局
Percentage of Participants With Rosenberg Score at Indicated Time Points
时间窗: baseline, 1 hour, 2 hours, 4 hours, 1 week
2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.
次要结局
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour(1hr)
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours(2hr)
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours(4 hours)
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week(1 week)
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour(1 hour)
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours(2 hours)
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours(4 hours)
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week(1 week)
- Number of Bacteria on Tongue at 1 Week(1 week)
- Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate(1 week)