Back to resultsEffect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)
Primary Purpose
Halitosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofresh® 4plus
Placebo
Sponsored by
About this trial
This is an interventional other trial for Halitosis
Eligibility Criteria
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.
Sites / Locations
- Salus Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Investigational lozenge
Placebo lozenge
Arm Description
Lozenge containing the enzyme polyphenol oxidase and green coffee extract
Lozenge equal to active comparator but without active ingredients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
T-VSCs over time
T-VSCs over time, based on OralChroma™ following daily product use
Specific VSCs over time
VSCs components [Hydrogen Sulfide (H2S), Methyl Mercaptan (CH3SH), and Dimethyl Sulfide (CH3SCH3) gases] over time following daily product use
Questionnaire
Post-product use questionnaire
Oral microbiome composition
Microbiome profile by 16S rRNA sequencing, saliva and tongue biofilm samples collected
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05413382
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novozymes A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational lozenge
Arm Type
Active Comparator
Arm Description
Lozenge containing the enzyme polyphenol oxidase and green coffee extract
Arm Title
Placebo lozenge
Arm Type
Placebo Comparator
Arm Description
Lozenge equal to active comparator but without active ingredients
Intervention Type
Dietary Supplement
Intervention Name(s)
Biofresh® 4plus
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immediate Total Volatile Sulphur Compounds (T-VSC)
Description
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.
Time Frame
The change in T-VSCs from baseline to 5-minutes post-product assessment
Secondary Outcome Measure Information:
Title
T-VSCs over time
Description
T-VSCs over time, based on OralChroma™ following daily product use
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
Title
Specific VSCs over time
Description
VSCs components [Hydrogen Sulfide (H2S), Methyl Mercaptan (CH3SH), and Dimethyl Sulfide (CH3SCH3) gases] over time following daily product use
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
Title
Questionnaire
Description
Post-product use questionnaire
Time Frame
Day 1 and Day 8
Title
Oral microbiome composition
Description
Microbiome profile by 16S rRNA sequencing, saliva and tongue biofilm samples collected
Time Frame
Day 1 (pre and immediate post-product use, 5 minutes) and Day 8
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events
Description
Interviews to determine adverse events
Time Frame
Day 1 (4 hours) and Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caterina Holz, PhD
Organizational Affiliation
Novozymes A/S
Official's Role
Study Director
Facility Information:
Facility Name
Salus Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)
We'll reach out to this number within 24 hrs