Effect of a Probiotic Water on Oral Health in Adults (NCT04473404) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Probiotic Water on Oral Health in Adults
United States48 participantsStarted 2020-07-20
Plain-language summary
The purpose of this study is to evaluate the effects of consuming a probiotic on salivary, plaque, and tongue bacteria, as well as oral malodor (bad breath). Healthy volunteers will consume a probiotic powder, or a placebo powder, that is dissolved in water for 4 weeks.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults, 18 to 65 years of age and in good general health and good oral health (no active or uncontrolled diseases or conditions).
✓. Presence of at least 20 natural teeth, excluding third molars.
✓. Read and sign the Research Subject Information and Consent Form.
✓. Have an OralChroma reading ≥ 125 ppb hydrogen sulfide (H2S) gas, volatile sulfur compound (VSC) (at least 8-12 hours after eating or drinking or oral hygiene) at Baseline.
✓. Willingness to use the assigned products according to instructions, attend scheduled appointments, and likelihood of completing the study.
✓. Males and females with reproductive potential agree to use medically acceptable contraception, as determined by the investigator, for the duration of the study and 30 days after study completion and attest to having used it for three months prior to screening.
✓. Females of child-bearing potential agree to submit to a urine pregnancy test at screening and at the end of the study.
Exclusion criteria
✕. Fewer than 20 natural, uncrowned teeth.
✕. Active or chronic dental disease.
✕. Self-reported dry mouth (xerostomia) by questionnaire.
✕. Have had or used any of the following in the past three months: antibiotic treatment, a dental cleaning, mouthrinse.