- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413382
Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)
June 7, 2022 updated by: Novozymes A/S
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46825
- Salus Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
To be eligible for study participation, subjects must meet the following criteria:
Inclusion criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Investigational lozenge
Lozenge containing the enzyme polyphenol oxidase and green coffee extract
|
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 Comparator: Placebo lozenge
Lozenge equal to active comparator but without active ingredients
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate Total Volatile Sulphur Compounds (T-VSC)
Time Frame: 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.
|
The change in T-VSCs from baseline to 5-minutes post-product assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T-VSCs over time
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
|
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
|
Specific VSCs over time
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
|
VSCs components [Hydrogen Sulfide (H2S), Methyl Mercaptan (CH3SH), and Dimethyl Sulfide (CH3SCH3) gases] over time following daily product use
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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
Time Frame: Day 1 and Day 8
|
Post-product use questionnaire
|
Day 1 and Day 8
|
Oral microbiome composition
Time Frame: 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
|
Day 1 (pre and immediate post-product use, 5 minutes) and Day 8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Day 1 (4 hours) and Day 8
|
Interviews to determine adverse events
|
Day 1 (4 hours) and Day 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Caterina Holz, PhD, Novozymes A/S
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2021
Primary Completion (Actual)
November 4, 2021
Study Completion (Actual)
December 22, 2021
Study Registration Dates
First Submitted
October 5, 2021
First Submitted That Met QC Criteria
June 7, 2022
First Posted (Actual)
June 10, 2022
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NZ-OHBF-2021-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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