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

NCT06437262 | Completed Phase 1

• 1 other identifier: 2021-CE161
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Saliva; Biofilms

Outcome Measures

Primary Outcomes (15)

• 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

• 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

Study Arms (2)

0.20% CHX gel

ACTIVE COMPARATOR

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; Drug: 0.20% CHX gel on oral biofilm

0.20% CHX and Cymenol gel

EXPERIMENTAL

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; Drug: 0.20% CHX and Cymenol gel on oral biofilm

Interventions

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 gel

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 and Cymenol gel

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 gel

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.

0.20% CHX and Cymenol gel

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Lacer S.A.: collaborator

Study Sites (1)

University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

Location

Study Officials

• Inmaculada Tomás, Prof

  University of Santiago de Compostela, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: September 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)