New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Colour evaluation of the new chair side test
研究概览
简要总结
This study will assess the ability of a first prototype (strip) of a new chair side test to detect oral malodour. The strip is based on a new enzymatic reaction able to detect amines in saliva. Previous studies already showed significant correlations between oral malodor and the levels of amines in saliva. The limitation in their use as markers of oral malodour is the fact that the detection is usually carried out by complex techniques (High Performance Liquid Chromatography(HPLC)and Solid-Phase Micro Extraction-Gas Chromatography/Mass Spectrometry (SPME-GC/MS)). The results of the new enzymatic reaction can be evaluated by means of a colorimetric scale without necessity of extra apparatus.
The study will be carried out with volunteers recruited at a multidisciplinary consultation for bad breath, organized at the University Hospital Leuven, Belgium.
The paper strip will be used before the routine evaluation (organoleptic score (OS), the gold standard method for the diagnosis of halitosis and the level of volatile sulphur compounds (VSC), the most used adjunct tool to diagnose halitosis).
The results of the new chair side test (strip) will be correlated with the OS and VSC measurements (OralChroma™, Halimeter®). The sensitivity, specificity and positive and negative predicted values of the new chair side test will be calculated. The cut-off values for a yes/no test will be determined. The meaning of color scores will be analyzed to assign a meaningful outcome to each score with relation to odor intensity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥18 years
- •With no evidence of bad breath or bad breath of intra-oral cause (oral malodour)
- •Non-smokers or smokers from whom the organoleptic evaluation can be performed (no interference from smoke odour)
排除标准
- •Smokers from whom the organoleptic evaluation can not be performed because of interference from smoke odour
- •Presence of active caries
- •Presence of sinusitis or any other Oro-pharyngeal problem
- •On medications which can cause malodour
- •Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
- •Any oral pathophysiological condition or any oral disease (e.g. oral cancer, mucositis)
- •Pregnancy and nursing
- •Situation considered not compatible with the study according to the investigator's opinion; the latter includes: 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.
结局指标
主要结局
Colour evaluation of the new chair side test
时间窗: Once (during the first consult to the clinic)
The colour will be assessed before all the other test and after 4 minutes of contact between the strip and the saliva of the volunteer.
次要结局
- Specific VSC readings(Once (during the first consult to the clinic))
- Organoleptic evaluation (OS)(Once (during the first consult to the clinic))
- Total VSC reading(Once (during the first consult to the clinic))
研究者
Marc Quirynen
PhD DDS
Universitaire Ziekenhuizen KU Leuven