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

NCT05413382 | Completed

• 1 other identifier: NZ-OHBF-2021-02
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• Questionnaire

  Day 1 and Day 8

• Oral microbiome composition

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

Other Outcomes (1)

• Incidence of adverse events

  Day 1 (4 hours) and Day 8

Study Arms (2)

Investigational lozenge

ACTIVE COMPARATOR

Lozenge containing the enzyme polyphenol oxidase and green coffee extract

Dietary Supplement: Biofresh® 4plus

Placebo lozenge

PLACEBO COMPARATOR

Lozenge equal to active comparator but without active ingredients

Dietary Supplement: Placebo

Interventions

Biofresh® 4plus DIETARY_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.

Investigational lozenge

Placebo DIETARY_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.

Placebo lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy males and females ≥18 years of age.
• Able to read, sign and receive a copy of the signed informed consent form.
• 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.
• 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).
• Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam.
• Have at least 18 natural teeth.
• 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.
• 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.
• Agree to refrain from tongue brushing/cleaning for the duration of the study.
• Adequate oral hygiene and no signs of oral neglect.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• 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.
• History of allergies to ingredients in the test product.
• Self-reported as pregnant or nursing.
• Self-reported serious medical conditions.
• Based on history and clinical exam: advanced and/or untreated periodontitis, frank caries, and mucosal diseases.
• Antibiotic or anti-inflammatory medication within 30 days of screening visit.

Sponsors & Collaborators

• Novozymes A/S: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caterina Holz, PhD

  Novozymes A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: June 10, 2022
• Study Start: September 28, 2021
• Primary Completion: November 4, 2021
• Study Completion: December 22, 2021
• Last Updated: June 10, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)