A Randomized, Double-Blind, Crossover, Clinical Study to Investigate the Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Immediate Total Volatile Sulphur Compounds (T-VSC)
研究概览
简要总结
This study is designed to evaluate the effect of an investigational lozenge with the enzyme polyphenol oxidase and green coffee extract in reducing and controlling intra-oral halitosis following immediate use and daily use of the lozenge over a one-week period.
详细描述
This randomized, placebo controlled, double-blind, crossover study will use gas chromatography (GC) and oral microbial measurements to evaluate the reduction and control of intra-oral halitosis by an investigational lozenge containing the enzyme polyphenol oxidase and green coffee extract compared to a placebo control lozenge. A one-week washout period will precede the first crossover period and a one-week washout period will be implemented between periods 1 and 2. The study will consist of five study visits: Screening Visit, Period 1 Baseline Visit, Crossover Period 1 Day 8 Visit, Period 2 Baseline Visit, Crossover Period 2 Day 8 Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •To be eligible for study participation, subjects must meet the following criteria:
- •Inclusion criteria:
- •Generally healthy males and females ≥18 years of age.
- •Able to read, sign and receive a copy of the signed informed consent form.
- •Have an average OralChroma™ reading ≥ 125 ppb hydrogen sulfide (H2S gas), volatile sulfur compound (VSC), based on 2 VSC measurements at Screening (Visit 1) and Baseline (Visit each 2 and 4), at least 12 hours after eating or drinking or oral hygiene.
- •Difference of the hydrogen sulfide gas readings is ≤ 500 ppb following the two mouth air samples for each VSC measurement for Screening (Visit 1) and Baseline (Visits 2 and 4).
- •Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam.
- •Have at least 18 natural teeth.
- •Agree to abstain from eating, drinking, breath mints, chewing gum, and any oral hygiene for at least 12 hours prior to evaluation of oral malodor at Screening, Baseline and Day 8 visits.
- •Agree to avoid drinking alcohol beverages and eating spicy foods, garlic and onions, cabbage, spices, cauliflower, and radishes (sulfur compounds) 48 hours prior to each study visit.
- •Agree to refrain from tongue brushing/cleaning for the duration of the study.
- •Adequate oral hygiene and no signs of oral neglect.
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •History of allergy or significant adverse effects following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
- •History of allergies to ingredients in the test product.
- •Self-reported as pregnant or nursing.
- •Self-reported serious medical conditions.
- •Based on history and clinical exam: advanced and/or untreated periodontitis, frank caries, and mucosal diseases.
- •Antibiotic or anti-inflammatory medication within 30 days of screening visit.
研究组 & 干预措施
Investigational lozenge
Lozenge containing the enzyme polyphenol oxidase and green coffee extract
干预措施: Biofresh® 4plus (Dietary Supplement)
Placebo lozenge
Lozenge equal to active comparator but without active ingredients
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Immediate Total Volatile Sulphur Compounds (T-VSC)
时间窗: The change in T-VSCs from baseline to 5-minutes post-product assessment
The primary efficacy endpoint is the immediate (no later than 5 minutes after dissolution of the lozenge) T-VSCs at Day 1 based on OralChroma™ measurement.
次要结局
- Questionnaire(Day 1 and Day 8)
- T-VSCs over time(The change in T-VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments)
- Specific VSCs over time(The change in specific VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments)
- Oral microbiome composition(Day 1 (pre and immediate post-product use, 5 minutes) and Day 8)