Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software

Phase 1

Completed

• Conditions: Healthy; Dental Plaque
• Interventions: Drug: Placebo Mouthwash; Drug: Cymenol mouthwash

• Registration Number: NCT05521230
• Lead Sponsor: University of Santiago de Compostela

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-04-30
• Study First Submitted: 2022-07-25
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-29
• Last Update Submitted: 2022-08-29
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Mouthwash	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)
Cymenol (test)	Cymenol mouthwash	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)

Primary Outcome Measures

Name	Time	Method
Change in the plaque area: 4 days vs 8 days	4 days, 8 days	Change in the percentage of the tooth surface with dental plaque: 4 days vs 8 days
Change in the plaque area: baseline vs 8 days	Baseline, 8 days	Change in the percentage of the tooth surface with dental plaque: baseline vs 8 days
Change in the plaque area: baseline vs 4 days	Baseline, 4 days	Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days
Change in the growth rate of dental plaque area: baseline vs 4 days	Baseline, 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	Baseline, 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	4 days vs 8 days	Change in the growth rate of dental plaque area (percentage area/hour): 4 days vs 8 days

Trial Locations

Locations (1)

University of Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain