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Completed

NCT Number: NCT06437262

Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva

The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.

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Key information

Conditions

Healthy Biofilms Saliva

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

  • Systemically healthy volunteers
  • Age between 20-45 years
  • Presence of minimum 24 permanent teeth
  • No evidence of gingivitis or periodontitis (CPITN= 0)
  • No presence of untreated caries at the start of the study

Exclusion criteria

  • Smoker or ex-smoker
  • Presence of dental protheses or orthodontic appliances
  • Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
  • Presence of any systemic disease that could alter saliva production or composition

Treatment and study plan

0.20% CHX gel on saliva

Drug

In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.

0.20% CHX and Cymenol gel on saliva

Drug

In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.

0.20% CHX gel on oral biofilm

Drug

Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.

0.20% CHX and Cymenol gel on oral biofilm

Drug

Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.

Primary outcomes

  1. Intragel bacterial viability: baseline vs 5 minutes

    Time frame: Baseline, 5 minutes

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 minutes

  2. Intragel bacterial viability: baseline vs 1 hour

    Time frame: Baseline, 1 hour

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 1 hour

  3. Intragel bacterial viability: baseline vs 3 hours

    Time frame: Baseline, 3 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 3 hours

  4. Intragel bacterial viability: baseline vs 5 hours

    Time frame: Baseline, 5 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 hours

  5. Intragel bacterial viability: baseline vs 7 hours

    Time frame: Baseline, 7 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 7 hours

  6. Intragel bacterial viability: 5 minutes vs 1 hour

    Time frame: 5 minutes, 1 hour

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 1 hour

  7. Intragel bacterial viability: 5 minutes vs 3 hours

    Time frame: 5 minutes, 3 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 3 hours

  8. Intragel bacterial viability: 5 minutes vs 5 hours

    Time frame: 5 minutes, 5 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 5 hours

  9. Intragel bacterial viability: 5 minutes vs 7 hours

    Time frame: 5 minutes, 7 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 7 hours

  10. Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel

    Time frame: Baseline

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

  11. Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel

    Time frame: 5 minutes

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 minutes: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

  12. Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel

    Time frame: 1 hour

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

  13. Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel

    Time frame: 3 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

  14. Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel

    Time frame: 5 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

  15. Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel

    Time frame: 7 hours

    Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Collaborators

  • Lacer S.A.

Registry information

Official study title

Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2024
Registry last updated
Jul 29, 2024

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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