Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142409
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-16
Brief Title:
Effect of Enzyme-containing Lozenge on Dental Biofilm Formation Composition and Functionality
Sponsor:
Novozymes AS
Organization:
Novozymes AS
Study Overview
Official Title:
The Effect of Non-biocidal Adjuncts on the Formation Composition Functionality and Microscale Architecture of Dental Biofilms a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blind placebo-controlled randomized cross-over trial evaluating the effect of enzyme-containing lozenge on in vivo and in situ grown dental biofilm accumulation The study includes two phases one each for the investigation of in-vivo and in-situ grown dental biofilm
Detailed Description:
Up to 50 subjects aged 18 years old with 3 or more active caries lesion will be randomized to receive
Phase 1 The effect of multiple-enzyme treatment on plaque accumulation in vivo
Phase 1 includes two experimental periods lasting for one day each with a washout period of two weeks in between Each experimental period will include two visits at day 0 and day 1
At day 0 the participants will receive a professional tooth cleaning and be randomized to receive Sequence 1 or Sequence 2 in a double-blind randomized cross-over design
Sequence 1 3 active enzyme-containing lozenges per day for one day app 24h followed by a washout period of two weeks followed by 3 identical placebo lozenges per day for one day app 24h
Sequence 2 3 placebo lozenges per day for one day app 24h followed by a washout period of two weeks followed by 3 identical active enzyme lozenges per day for one day app 24h
The participants will be instructed to take one lozenge three times morning noon evening for one day No normal oral hygiene procedures will be allowed during the intervention periods of one day At the end of both experimental phases plaque is assessed using planimetric recordings obtained with an intraoral camera and TM-QHPI to provide information on the individual level of plaque formation
Phase 2 The effect of multiple-enzyme treatment on in situ-grown biofilms
The phase is designed in a double-blind randomized cross-over design including two experimental periods lasting for 2 days with a washout period of 5 days in between Each experimental period will include two visits on day 0 and day 2 Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 48 hours The glass slabs will be mounted on the individual lower-jaw splints
At day 0 the participants will be randomized to receive Sequence 1 or Sequence 2
Sequence 1 3 active enzyme-containing lozenges per day for 2 days followed by a washout period of 5 days followed by 3 identical placebo lozenges per day for 2 days
Sequence 2 3 placebo lozenges per day for 2 days followed by a washout period of 5 days followed by 3 identical active enzyme lozenges per day for 2 days
Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 2-4 experimental periods of 48 hours After each experimental period the in situ-grown biofilms will be collected and stored in a research biobank
Phase 1 The effect of multiple-enzyme treatment on plaque accumulation in vivo
Phase 1 includes two experimental periods lasting for one day each with a washout period of two weeks in between Each experimental period will include two visits at day 0 and day 1
At day 0 the participants will receive a professional tooth cleaning and be randomized to receive Sequence 1 or Sequence 2 in a double-blind randomized cross-over design
Sequence 1 3 active enzyme-containing lozenges per day for one day app 24h followed by a washout period of two weeks followed by 3 identical placebo lozenges per day for one day app 24h
Sequence 2 3 placebo lozenges per day for one day app 24h followed by a washout period of two weeks followed by 3 identical active enzyme lozenges per day for one day app 24h
The participants will be instructed to take one lozenge three times morning noon evening for one day No normal oral hygiene procedures will be allowed during the intervention periods of one day At the end of both experimental phases plaque is assessed using planimetric recordings obtained with an intraoral camera and TM-QHPI to provide information on the individual level of plaque formation
Phase 2 The effect of multiple-enzyme treatment on in situ-grown biofilms
The phase is designed in a double-blind randomized cross-over design including two experimental periods lasting for 2 days with a washout period of 5 days in between Each experimental period will include two visits on day 0 and day 2 Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 48 hours The glass slabs will be mounted on the individual lower-jaw splints
At day 0 the participants will be randomized to receive Sequence 1 or Sequence 2
Sequence 1 3 active enzyme-containing lozenges per day for 2 days followed by a washout period of 5 days followed by 3 identical placebo lozenges per day for 2 days
Sequence 2 3 placebo lozenges per day for 2 days followed by a washout period of 5 days followed by 3 identical active enzyme lozenges per day for 2 days
Oral biofilms will be grown in situ on prefabricated non-fluorescent glass slabs for 2-4 experimental periods of 48 hours After each experimental period the in situ-grown biofilms will be collected and stored in a research biobank
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?:
None