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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06437262

Enrollment

Registered

2024-05-31

Start date

2022-09-01

Completion date

2023-07-31

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biofilms, Healthy, Saliva

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.

Interventions

DRUG0.20% 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.

DRUG0.20% 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.

DRUG0.20% 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.

DRUG0.20% 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
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 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 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
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: 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 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 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 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.
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.
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.
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026