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

Healthy Clinical Trial

Official title:

Randomised Clinical Trial on the Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521230
• Other study ID #: 2021_CE112
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2022
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque
• Healthy

Intervention

Drug:
• Placebo Mouthwash
Application of mouthwashes
• Cymenol mouthwash
Application of mouthwashes

Locations

Country	Name	City	State
Spain	University of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Lacer, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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