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Completed

NCT Number: NCT05521230

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

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Key information

Conditions

Healthy Dental Deposits Dental Plaque Stomatognathic Diseases Tooth Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Mouthwash

Drug

Application of mouthwashes

Cymenol mouthwash

Drug

Application of mouthwashes

Primary outcomes

  1. Change in the plaque area: baseline vs 4 days

    Time frame: Baseline, 4 days

    Change in the percentage of the tooth surface with dental plaque:baseline vs 4 days

  2. Change in the plaque area: baseline vs 8 days

    Time frame: Baseline, 8 days

    Change in the percentage of the tooth surface with dental plaque: baseline vs 8 days

  3. Change in the plaque area: 4 days vs 8 days

    Time frame: 4 days, 8 days

    Change in the percentage of the tooth surface with dental plaque: 4 days vs 8 days

  4. Change in the growth rate of dental plaque area: baseline vs 4 days

    Time frame: Baseline, 4 days

    Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 4 days

  5. Change in the growth rate of dental plaque area: baseline vs 8 days

    Time frame: Baseline, 8 days

    Change in the growth rate of dental plaque area (percentage area/hour): baseline vs 8 days

  6. Change in the growth rate of dental plaque area: 4 days vs 8 days

    Time frame: 4 days vs 8 days

    Change in the growth rate of dental plaque area (percentage area/hour): 4 days vs 8 days

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Collaborators

  • Lacer S.A.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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