Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals

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

Detailed Description
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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.

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

Conditions
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Dental Plaque

Intervention / Treatment
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* Other: Enzyme lozenge 1
* Other: Enzyme lozenge 2
* Other: Placebo lozenge


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enzyme lozenge 1<br>The lozenge contains three plaque extracellular matrix degrading enzymes | Other: Enzyme lozenge 1<br>* 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.<br>|
| Active Comparator: Enzyme lozenge 2<br>The concentration of the three enzymes in the Enzyme lozenge 2 is threefold the enzyme concentration than in the Enzyme lozenge 1 | Other: Enzyme lozenge 2<br>* 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.<br>|
| Placebo Comparator: Placebo lozenge<br>The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture | Other: Placebo lozenge<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Change in QHPI score from baseline to 24 hours' follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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. | Day 14 visit | 
| Oral microbiome | Oral microbiome composition | 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. | Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enzymes, Dental plaque, Gingivitis, Oral microbiome