NCT05070507

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novozymes A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Plaque
• Gingivitis
• Microbial Colonization

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Enzyme containing lozenge	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.
DIETARY_SUPPLEMENT	Placebo lozenge	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.

Timeline

• Start date: 2021-01-08
• Primary completion: 2021-02-26
• Completion: 2021-05-10
• First posted: 2021-10-07
• Last updated: 2021-10-07

Locations

1 site across 1 country: Denmark