Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 11:19 PM
Study NCT ID:
NCT05082103
Status:
TERMINATED
Last Update Posted:
2022-06-09
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals
Sponsor:
Novozymes A/S
Organization:
Study Overview
Official Title:
Effect of Enzyme-containing Lozenges on Dental Biofilm Accumulation in Healthy Individuals: A Randomized Placebo-controlled Clinical Trial
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated after interim data analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: