Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.

Novozymes

Status: Completed

Conditions: Dental Plaque; Microbial Colonization; Gingivitis

Treatments: Dietary Supplement: Placebo lozenge; Dietary Supplement: Enzyme containing lozenge

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05070507

NZ-OHBFC-2020-04

Details and patient eligibility

About

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

Full description

The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Enzyme containing lozenge

Experimental group

Treatment:

Dietary Supplement: Enzyme containing lozenge

Placebo lozenge

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo lozenge