Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

Novozymes A/S80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Dental Plaque

Interventions

Enzyme lozenge 1OTHER

Participants are instructed to take one enzyme containing lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.

Enzyme lozenge 2OTHER

Participants are instructed to take one lozenge with 3x higher enzyme concentration three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.

Placebo lozengeOTHER

Participants are instructed to take one placebo lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Aarhus University, Department of Dentistry and Oral Health

Aarhus, Denmark

Outcomes

Primary Outcomes

Plaque amount

Dental plaque accumulation after 1-day use of either a test or placebo investigational lozenge assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)

Time frame: Change in QHPI score from baseline to 24 hours' follow-up

Secondary Outcomes

Plaque amount

Dental plaque accumulation after 7 and 14 days assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque)

Time frame: Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up

Gingivitis

Development of gingivitis after 14 days assessed by the Gingival Index of Löe and Silness (GI) (score 0-3, 0 being no gingivitis, 3 being excessive gingivitis)

Time frame: Change in GI from baseline to Day 14 follow-up

Plaque removal

Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator.

Time frame: Day 14 visit

Oral microbiome

Oral microbiome composition

Time frame: Change in microbiome composition from baseline to Day 14 follow-up

Plaque fluorescence intensity measurement

Dental plaque accumulation assessed by fluorescence intensity measurements, to provide information on the individual level of plaque formation. Soft biofilm on the teeth is calculated using an appropriate software program, compatible with the device used.

Time frame: Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up

Data from ClinicalTrials.gov

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