Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change from baseline organoleptic score of breath (OLS)
研究概览
简要总结
Bad breath or halitosis is caused by specific gases originating from the mouth or the expired air. In most cases the pathology lies within the mouth and in this case receives the name pathologic halitosis of oral cause or oral malodor. The aim of this study is to evaluate the immediate (masking) and long term (therapeutic) effect of commercially available mouth rinses in the treatment of oral malodor. For this volunteers with oral malodor detected by organoleptic evaluation and confirmed by the increase level of sulphur compounds in their breath (VSC) will be asked to use a designated mouthwash. The breath parameters will be assessed at baseline and 15' after the first rinse (15 ml, during 1 minute) and over night at the end of a period of 3 weeks during which the volunteers rinsed twice a day (15 ml, 1 minute) with the assigned mouthwash. The short and long term effect of a stannous fluoride/amine fluoride/zinc rinse; a chlorhexidine/cetylpyridinium chloride/zinc product and a negative control(fluoride rinse and/or water) will be compared.
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
- •Caucasian
- •Age ≥ 18 years
- •Organoleptic score of breath ≥ 2
- •VSC readings (sum of H2S and CH3SH by OralChroma) ≥ 120 ppb*
- •Intra-oral cause of bad breath
- •Non-smokers
- •Willing to participate and able to give written informed consent
排除标准
- •Ongoing dental treatment or any other medical treatment of the oral cavity
- •Any known allergy to previously used oral hygiene products or any known allergy to any of the ingredients of the study products, which are used during the study
- •Any pathological change of the oral mucosa
- •Use of prohibited treatments / therapies and/or abuse of drugs, alcohol, etc
- •Pregnancy or breastfeeding
- •Active caries
- •Acute sinusitis
- •Severe oro-pharyngeal infections
- •On medications which can cause malodour
- •Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
- •Situation considered not compatible with the study according to the investigator's opinion; the latter includes: patients eating very spicy food, persons under homeopathic therapy, patients who used antibiotics during the 2 months before the study, patients frequently using chewing gum, patients under corticosteroids or other serious medications.
- •Patients unwilling to abstain from additional oral hygiene (only toothbrushing allowed) particularly mouthrinse, chewing gums, breath strips, etc
结局指标
主要结局
Change from baseline organoleptic score of breath (OLS)
时间窗: after15' and after 3 weeks
A trained and calibrated "judge" sniffs the expired air of the volunteer and assesses whether it is unpleasant by using an intensity rating, normally from 0 to 5, with 0 = no odor present, 1 = barely noticeable odor, 2 = slight but clearly noticeable odor, 3 = moderate odor, 4 = strong offensive odor, and 5 = extremely foul odor (proposed by Rosenberg and McCulloch.
Change from baseline in H2S and CH3SH level in breath
时间窗: after 15' and after 3 weeks
A portable gas chromatograph (OralChroma™, Abilit Corporation, Kanagawa, Japan) will be used to measures the concentration of hydrogen sulphur (H2S) and methyl mercaptan (CH3SH) in mouth air. The device has been calibrated and validated for its use by the manufacturer.
次要结局
- Change from baseline global level of volatile sulphur compounds (VSC)(after 15' and after 3 weeks)
- Change from baseline microbial load of saliva(after 3 weeks)
- Change from baseline microbial load of tongue coating(after 3 weeks)
研究者
Marc Quirynen
PhD DDS
Universitaire Ziekenhuizen KU Leuven