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

Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine 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.

Study Overview

• Status: Completed
• Conditions: Healthy; Saliva; Biofilms
• Intervention / Treatment: Drug: 0.20% CHX gel on saliva; Drug: 0.20% CHX gel on oral biofilm; Drug: 0.20% CHX and Cymenol gel on saliva; Drug: 0.20% CHX and Cymenol gel on oral biofilm

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15782
      • University of Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.20% CHX gel; Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.	Drug: 0.20% CHX gel on saliva; 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.; Drug: 0.20% CHX gel on oral biofilm; 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.
Experimental: 0.20% CHX and Cymenol gel; Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.	Drug: 0.20% CHX and Cymenol gel on saliva; 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.; Drug: 0.20% CHX and Cymenol gel on oral biofilm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.	Baseline
Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.	5 minutes
Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.	1 hour
Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.	3 hours
Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.	5 hours
Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.	7 hours
Intragel bacterial viability: baseline vs 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	Baseline, 5 minutes
Intragel bacterial viability: baseline vs 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	Baseline, 1 hour
Intragel bacterial viability: baseline vs 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	Baseline, 3 hours
Intragel bacterial viability: baseline vs 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	Baseline, 5 hours
Intragel bacterial viability: baseline vs 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	Baseline, 7 hours
Intragel bacterial viability: 5 minutes vs 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	5 minutes, 1 hour
Intragel bacterial viability: 5 minutes vs 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	5 minutes, 3 hours
Intragel bacterial viability: 5 minutes vs 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	5 minutes, 5 hours
Intragel bacterial viability: 5 minutes vs 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	5 minutes, 7 hours

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Lacer, S.A.
• Investigators: Principal Investigator: Inmaculada Tomás, Prof, University of Santiago de Compostela, Spain

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: May 25, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021-CE161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No