Clinical trial NCT06437262: Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Saliva
Biofilms
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Lacer, S.A.
First posted: 2024-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intragel bacterial viability: baseline vs 5 minutes
timeFrame: Baseline, 5 minutes
measure: Intragel bacterial viability: baseline vs 1 hour
timeFrame: Baseline, 1 hour
measure: Intragel bacterial viability: baseline vs 3 hours
timeFrame: Baseline, 3 hours
measure: Intragel bacterial viability: baseline vs 5 hours
timeFrame: Baseline, 5 hours
measure: Intragel bacterial viability: baseline vs 7 hours
timeFrame: Baseline, 7 hours
measure: Intragel bacterial viability: 5 minutes vs 1 hour
timeFrame: 5 minutes, 1 hour
measure: Intragel bacterial viability: 5 minutes vs 3 hours
timeFrame: 5 minutes, 3 hours
measure: Intragel bacterial viability: 5 minutes vs 5 hours
timeFrame: 5 minutes, 5 hours
measure: Intragel bacterial viability: 5 minutes vs 7 hours
timeFrame: 5 minutes, 7 hours
measure: Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel
timeFrame: Baseline
measure: Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel
timeFrame: 5 minutes
measure: Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel
timeFrame: 1 hour
measure: Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
timeFrame: 3 hours
measure: Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
timeFrame: 5 hours
measure: Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel
timeFrame: 7 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela, Spain
name: Inmaculada Tomás, Prof
role: PRINCIPAL_INVESTIGATOR
References: