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

Halitosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413382
• Other study ID #: NZ-OHBF-2021-02
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: December 22, 2021

Study information

• Verified date: October 2021
• Source: Novozymes A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 22, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Halitosis

Intervention

Dietary Supplement:
• Biofresh® 4plus
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Salus Research	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Novozymes A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	Interviews to determine adverse events	Day 1 (4 hours) and Day 8
Primary	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.	The change in T-VSCs from baseline to 5-minutes post-product assessment
Secondary	T-VSCs over time	T-VSCs over time, based on OralChroma™ following daily product use	The change in T-VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments
Secondary	Specific VSCs over time	VSCs components [Hydrogen Sulfide (H2S), Methyl Mercaptan (CH3SH), and Dimethyl Sulfide (CH3SCH3) gases] over time following daily product use	The change in specific VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments
Secondary	Questionnaire	Post-product use questionnaire	Day 1 and Day 8
Secondary	Oral microbiome composition	Microbiome profile by 16S rRNA sequencing, saliva and tongue biofilm samples collected	Day 1 (pre and immediate post-product use, 5 minutes) and Day 8