Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (In… (NCT05413382) | Clinical Trial Compass
CompletedNot Applicable
Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)
United States53 participantsStarted 2021-09-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. 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.
What they're measuring
1
Immediate Total Volatile Sulphur Compounds (T-VSC)
Timeframe: The change in T-VSCs from baseline to 5-minutes post-product assessment