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

U

University of Santiago de Compostela

Status and phase

Completed
Phase 1

Conditions

Dental Plaque
Healthy

Treatments

Drug: Cymenol mouthwash
Drug: Placebo Mouthwash

Study type

Interventional

Funder types

Other

Identifiers

NCT05521230
2021_CE112

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
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)
Treatment:
Drug: Placebo Mouthwash
Cymenol (test)
Experimental group
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)
Treatment:
Drug: Cymenol mouthwash

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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