Clinical trial NCT05413382: Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Lead sponsor: Novozymes A/S
Sponsor class: INDUSTRY
First posted: 2022-06-10
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immediate Total Volatile Sulphur Compounds (T-VSC)
timeFrame: The change in T-VSCs from baseline to 5-minutes post-product assessment
Secondary outcomes:
measure: T-VSCs over time
timeFrame: The change in T-VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments
measure: Specific VSCs over time
timeFrame: The change in specific VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments
measure: Questionnaire
timeFrame: Day 1 and Day 8
measure: Oral microbiome composition
timeFrame: Day 1 (pre and immediate post-product use, 5 minutes) and Day 8
Other outcomes:
measure: Incidence of adverse events
timeFrame: Day 1 (4 hours) and Day 8
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
affiliation: Novozymes A/S
name: Caterina Holz, PhD
role: STUDY_DIRECTOR
References: