An interventional study of Biofresh® 4plus and Placebo in Halitosis, sponsored by Novozymes A/S. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by Novozymes A/S · Not applicable, Interventional, and Other
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.
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.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's enrollment of 53 is above the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →Novozymes A/S is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for study participation, subjects must meet the following criteria:
Inclusion criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lozenge containing the enzyme polyphenol oxidase and green coffee extract
Dietary Supplement: Biofresh® 4plus
Lozenge equal to active comparator but without active ingredients
Dietary Supplement: 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.
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.
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.
Time frame: The change in T-VSCs from baseline to 5-minutes post-product assessment
T-VSCs over time
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
Specific VSCs over time
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
Questionnaire
Post-product use questionnaire
Time frame: Day 1 and Day 8
Oral microbiome composition
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
Incidence of adverse events
Interviews to determine adverse events
Time frame: Day 1 (4 hours) and Day 8
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Nov 2021, 1 month.
Of 43 interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Novozymes A/S