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

Not Applicable

Completed

• Conditions: Halitosis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Biofresh® 4plus

• Registration Number: NCT05413382
• Lead Sponsor: Novozymes A/S

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.

Study Timeline

• Study Start: 2021-09-28
• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Primary Completion: 2021-11-04
• Study Completion: 2021-12-22
• Study First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Study First Posted: 2022-06-10
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo lozenge	Placebo	Lozenge equal to active comparator but without active ingredients
Investigational lozenge	Biofresh® 4plus	Lozenge containing the enzyme polyphenol oxidase and green coffee extract

Primary Outcome Measures

Name	Time	Method
Immediate Total Volatile Sulphur Compounds (T-VSC)	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.

Secondary Outcome Measures

Name	Time	Method
Questionnaire	Day 1 and Day 8	Post-product use questionnaire
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	T-VSCs over time, based on OralChroma™ following daily product use
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	VSCs components \[Hydrogen Sulfide (H2S), Methyl Mercaptan (CH3SH), and Dimethyl Sulfide (CH3SCH3) gases\] over time following daily product use
Oral microbiome composition	Day 1 (pre and immediate post-product use, 5 minutes) and Day 8	Microbiome profile by 16S rRNA sequencing, saliva and tongue biofilm samples collected

Trial Locations

Locations (1)

Salus Research; 🇺🇸 Fort Wayne, Indiana, United States