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

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

Detailed 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.

Official Title
-----------------
Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.

Conditions
-----------------
Dental Plaque, Gingivitis, Microbial Colonization

Intervention / Treatment
-----------------
* Dietary Supplement: Enzyme containing lozenge
* Dietary Supplement: Placebo lozenge


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enzyme containing lozenge<br> | Dietary Supplement: Enzyme containing lozenge<br>* Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.<br>|
| Placebo Comparator: Placebo lozenge<br> | Dietary Supplement: Placebo lozenge<br>* Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulation of dental plaque after 24 hours | Dental plaque assessed by the modified Quigley-Hein Plaque Index | Change in dental plaque score from baseline to 24 hours' follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulation of dental plaque after 7 days | Dental plaque assessed by the modified Quigley-Hein Plaque Index | Change in dental plaque score from baseline to 7 days' follow-up | 
| Development of gingivitis after 7 days | Gingivitis assessed by the Silness-Löe Plaque Index | Change in gingivitis score from baseline to 7 days' follow-up | 
| Microbial characterization of the oral microbiome from plaque and saliva samples | Assessed by 16S rRNA sequencing | 7 days' follow-up |