Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
Primary Purpose
Healthy, Dental Plaque
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Placebo Mouthwash
Cymenol mouthwash
Sponsored by
About this trial
This is an interventional prevention trial for Healthy
Eligibility Criteria
Inclusion criteria were as follows:
- Systemically healthy volunteers
- Age between 20-45 years
- Presence of minimum of 24 permanent teeth
- No evidence of gingivitis or periodontitis (CPITN= 0)
- No presence of untreated caries at the start of the study.
Exclusion criteria were as follows:
- Smoker or ex-smoker
- Presence of dentures or orthodontic appliances
- Antibiotic treatment in the last 3 months or routine use of oral antiseptics
Sites / Locations
- University of Santiago de Compostela
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Cymenol (test)
Arm Description
Participants rinsed 10 ml of placebo mouthwash for a period of 60 seconds, three times a day with an interval of 7-9 hours in between, for 4 days (period 1)
Participants applied a 10 ml rinse of 0.1% cymenol mouthwash for a period of 60 seconds, three times a day with a 7-9 hour interval in between, for 4 days (period 1) and 4 days more (period 2)
Outcomes
Primary Outcome Measures
Change in the plaque area: baseline vs 4 days
Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days
Change in the plaque area: baseline vs 8 days
Change in the percentage of the tooth surface with dental plaque: baseline vs 8 days
Change in the plaque area: 4 days vs 8 days
Change in the percentage of the tooth surface with dental plaque: 4 days vs 8 days
Change in the growth rate of dental plaque area: baseline vs 4 days
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 4 days
Change in the growth rate of dental plaque area: baseline vs 8 days
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 8 days
Change in the growth rate of dental plaque area: 4 days vs 8 days
Change in the growth rate of dental plaque area (percentage area/hour): 4 days vs 8 days
Secondary Outcome Measures
Full Information
NCT ID
NCT05521230
First Posted
July 25, 2022
Last Updated
August 29, 2022
Sponsor
University of Santiago de Compostela
Collaborators
Lacer, S.A.
1. Study Identification
Unique Protocol Identification Number
NCT05521230
Brief Title
Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
Official Title
Randomised Clinical Trial on the Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela
Collaborators
Lacer, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Dental Plaque
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants rinsed 10 ml of placebo mouthwash for a period of 60 seconds, three times a day with an interval of 7-9 hours in between, for 4 days (period 1)
Arm Title
Cymenol (test)
Arm Type
Experimental
Arm Description
Participants applied a 10 ml rinse of 0.1% cymenol mouthwash for a period of 60 seconds, three times a day with a 7-9 hour interval in between, for 4 days (period 1) and 4 days more (period 2)
Intervention Type
Drug
Intervention Name(s)
Placebo Mouthwash
Intervention Description
Application of mouthwashes
Intervention Type
Drug
Intervention Name(s)
Cymenol mouthwash
Intervention Description
Application of mouthwashes
Primary Outcome Measure Information:
Title
Change in the plaque area: baseline vs 4 days
Description
Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days
Time Frame
Baseline, 4 days
Title
Change in the plaque area: baseline vs 8 days
Description
Change in the percentage of the tooth surface with dental plaque: baseline vs 8 days
Time Frame
Baseline, 8 days
Title
Change in the plaque area: 4 days vs 8 days
Description
Change in the percentage of the tooth surface with dental plaque: 4 days vs 8 days
Time Frame
4 days, 8 days
Title
Change in the growth rate of dental plaque area: baseline vs 4 days
Description
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 4 days
Time Frame
Baseline, 4 days
Title
Change in the growth rate of dental plaque area: baseline vs 8 days
Description
Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 8 days
Time Frame
Baseline, 8 days
Title
Change in the growth rate of dental plaque area: 4 days vs 8 days
Description
Change in the growth rate of dental plaque area (percentage area/hour): 4 days vs 8 days
Time Frame
4 days vs 8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria were as follows:
Systemically healthy volunteers
Age between 20-45 years
Presence of minimum of 24 permanent teeth
No evidence of gingivitis or periodontitis (CPITN= 0)
No presence of untreated caries at the start of the study.
Exclusion criteria were as follows:
Smoker or ex-smoker
Presence of dentures or orthodontic appliances
Antibiotic treatment in the last 3 months or routine use of oral antiseptics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inmaculada Tomás, Prof.
Organizational Affiliation
University of Santiago de Compostela, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15782
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
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