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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06437262
• Other study ID #: 2021-CE161
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2024
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Biofilms
• Healthy
• Saliva

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	University of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Lacer, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 vs 5 minutes
Primary	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 vs 1 hour
Primary	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 vs 3 hours
Primary	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 vs 5 hours
Primary	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 vs 7 hours
Primary	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 vs 1 hour
Primary	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 vs 3 hours
Primary	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 vs 5 hours
Primary	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 vs 7 hours
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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