Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)

Novozymes A/S53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Halitosis

Interventions

Biofresh® 4plusDIETARY_SUPPLEMENT

Participants will be instructed to use their assigned lozenge three times per day for seven days, preferably after breakfast, lunch, and dinner meals and to avoid eating and drinking for 30 minutes after consuming the lozenge.

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

To be eligible for study participation, subjects must meet the following criteria: Inclusion criteria: 1. Generally healthy males and females ≥18 years of age. 2. Able to read, sign and receive a copy of the signed informed consent form. 3. 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. 4. 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). 5. Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam. 6. Have at least 18 natural teeth. 7. 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. 8. 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. 9. Agree to refrain from tongue brushing/cleaning for the duration of the study. 10. Adequate oral hygiene and no signs of oral neglect. Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: 1. 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. 2. History of allergies to ingredients in the test product. 3. Self-reported as pregnant or nursing. 4. Self-reported serious medical conditions. 5. Based on history and clinical exam: advanced and/or untreated periodontitis, frank caries, and mucosal diseases. 6. Antibiotic or anti-inflammatory medication within 30 days of screening visit.

Locations (1)

Salus Research

Fort Wayne, Indiana, United States

Outcomes

Primary Outcomes

Immediate Total Volatile Sulphur Compounds (T-VSC)

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.

Time frame: The change in T-VSCs from baseline to 5-minutes post-product assessment

Secondary Outcomes

T-VSCs over time

T-VSCs over time, based on OralChroma™ following daily product use

Time frame: 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

VSCs components \[Hydrogen Sulfide (H2S), Methyl Mercaptan (CH3SH), and Dimethyl Sulfide (CH3SCH3) gases\] over time following daily product use

Time frame: The change in specific VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments

Questionnaire

Post-product use questionnaire

Time frame: Day 1 and Day 8

Oral microbiome composition

Microbiome profile by 16S rRNA sequencing, saliva and tongue biofilm samples collected

Time frame: Day 1 (pre and immediate post-product use, 5 minutes) and Day 8

Data from ClinicalTrials.gov

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