Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
Randomised Clinical Trial on the Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2021
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFirst Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedAugust 30, 2022
August 1, 2022
7 months
July 25, 2022
August 29, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Change in the plaque area: baseline vs 4 days
Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days
Baseline, 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
Baseline, 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
4 days, 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
Baseline, 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
Baseline, 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
4 days vs 8 days
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants 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)
Cymenol (test)
EXPERIMENTALParticipants 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Smoker or ex-smoker
- Presence of dentures or orthodontic appliances
- Antibiotic treatment in the last 3 months or routine use of oral antiseptics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Santiago de Compostelalead
- Lacer S.A.collaborator
Study Sites (1)
University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782, Spain
Related Publications (1)
Suarez-Rodriguez B, Regueira-Iglesias A, Blanco-Pintos T, Balsa-Castro C, Vila-Blanco N, Carreira MJ, Tomas I. Short-term anti-plaque effect of a cymenol mouthwash analysed using the DenTiUS Deep Plaque software: a randomised clinical trial. BMC Oral Health. 2023 Aug 12;23(1):560. doi: 10.1186/s12903-023-03256-9.
PMID: 37573292DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inmaculada Tomás, Prof.
University of Santiago de Compostela, Spain
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 25, 2022
First Posted
August 30, 2022
Study Start
September 1, 2021
Primary Completion
March 31, 2022
Study Completion
April 30, 2022
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share