Status:
COMPLETED
Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)
Lead Sponsor:
Novozymes A/S
Conditions:
Halitosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 immed...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05413382
Start Date
September 28 2021
End Date
December 22 2021
Last Update
June 10 2022
Active Locations (1)
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1
Salus Research
Fort Wayne, Indiana, United States, 46825