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

The objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the Dentius Deep Plaque software

Study Overview

• Status: Completed
• Conditions: Healthy; Dental Plaque
• Intervention / Treatment: Drug: Placebo Mouthwash; Drug: Cymenol mouthwash

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15782
      • University of Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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)	Drug: Placebo Mouthwash; Application of mouthwashes
Experimental: Cymenol (test); 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)	Drug: Cymenol mouthwash; Application of mouthwashes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Lacer, S.A.
• Investigators: Principal Investigator: Inmaculada Tomás, Prof., University of Santiago de Compostela, Spain

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: 2021_CE112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No