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

Phase 1

Completed

• Conditions: Healthy; Saliva; Biofilms
• Interventions: Drug: 0.20% CHX gel on saliva; Drug: 0.20% CHX and Cymenol gel on saliva; Drug: 0.20% CHX gel on oral biofilm; Drug: 0.20% CHX and Cymenol gel on oral biofilm

• Registration Number: NCT06437262
• Lead Sponsor: University of Santiago de Compostela

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31
• Study First Submitted: 2024-05-25
• Study First Submitted QC: 2024-05-25
• Study First Posted: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.20% CHX gel	0.20% CHX gel on saliva	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.
0.20% CHX gel	0.20% CHX gel on oral biofilm	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.
0.20% CHX and Cymenol gel	0.20% CHX and Cymenol gel on saliva	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.
0.20% CHX and Cymenol gel	0.20% CHX and Cymenol gel on oral biofilm	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.

Primary Outcome Measures

Name	Time	Method
Intragel bacterial viability: baseline vs 5 minutes	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
Intragel bacterial viability: baseline vs 5 hours	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
Intragel bacterial viability: 5 minutes vs 7 hours	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
Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.
Intragel bacterial viability: baseline vs 3 hours	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
Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.
Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.
Intragel bacterial viability: baseline vs 1 hour	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
Intragel bacterial viability: baseline vs 7 hours	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
Intragel bacterial viability: 5 minutes vs 5 hours	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
Intragel bacterial viability: 5 minutes vs 1 hour	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
Intragel bacterial viability: 5 minutes vs 3 hours	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
Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.
Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.
Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel	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.

Trial Locations

Locations (1)

University of Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain