Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

Novozymes

Status: Terminated

Conditions: Dental Plaque

Treatments: Other: Enzyme lozenge 2; Other: Placebo lozenge; Other: Enzyme lozenge 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05082103

NZ-OHBFC-2021-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 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.
• 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: Quadruple Blind

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80 participants in 3 patient groups, including a placebo group

Enzyme lozenge 1

Active Comparator group

Description:

The lozenge contains three plaque extracellular matrix degrading enzymes

Treatment:

Other: Enzyme lozenge 1

Enzyme lozenge 2

Active Comparator group

Description:

The concentration of the three enzymes in the "Enzyme lozenge 2" is threefold the enzyme concentration than in the "Enzyme lozenge 1"

Treatment:

Other: Enzyme lozenge 2

Placebo lozenge

Placebo Comparator group

Description:

The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture

Treatment:

Other: Placebo lozenge