Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals. (NCT05070507) | Clinical Trial Compass
CompletedNot Applicable
Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.
Denmark24 participantsStarted 2021-01-08
Plain-language summary
The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.
Who can participate
Age range18 Years
SexALL
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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 at least 20 natural teeth.
Exclusion Criteria:
* Clinically visible active caries lesions and/or periodontitis.
* Significant oral soft tissue pathology based on a visual examination.
* History of allergy or significant adverse events 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.
* History of allergies towards enzymes.
* Self-reported as pregnant or nursing.
* Self-reported serious medical conditions.
* Antibiotic or anti-inflammatory medication within 30 days of screening visit.
* Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures.
* Acute sinusitis or severe oral-pharyngeal infections.
What they're measuring
1
Accumulation of dental plaque after 24 hours
Timeframe: Change in dental plaque score from baseline to 24 hours' follow-up