Clinical trial NCT05082103: Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals
Official title: Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dental Plaque
Keywords: Enzymes
Dental plaque
Gingivitis
Oral microbiome
Lead sponsor: Novozymes A/S
Sponsor class: INDUSTRY
Collaborators: name: University of Aarhus
First posted: 2021-10-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

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.
* 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.

Primary outcomes:
measure: Plaque amount
timeFrame: Change in QHPI score from baseline to 24 hours' follow-up
Secondary outcomes:
measure: Plaque amount
timeFrame: Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up
measure: Gingivitis
timeFrame: Change in GI from baseline to Day 14 follow-up
measure: Plaque removal
timeFrame: Day 14 visit
measure: Oral microbiome
timeFrame: Change in microbiome composition from baseline to Day 14 follow-up
measure: Plaque fluorescence intensity measurement
timeFrame: Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department of Dentistry and Oral Health
Study officials:
affiliation: Novozymes A/S
name: Mette Rose Jørgensen, DDS, PhD
role: STUDY_DIRECTOR
affiliation: Aarhus University, Department of Dentistry and Oral Health
name: Sebastian Schlafer, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: