Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial

The purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.

The purpose of the study is to examine the clinical effects of lozenges containing three extracellular matrix-degrading enzymes on dental plaque accumulation and removal, prevention of gingivitis, and oral microbiome composition after professional tooth cleaning, as compared to a placebo lozenge without enzymes. Two different concentrations of the enzymes will be tested, to investigate a potential dose-dependent effect of the enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral mucosa. The null hypothesis is that treatment with enzyme-containing lozenges does not affect plaque accumulation as compared to a placebo control.

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.
• 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.