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
Verified date | May 2024 |
Source | University of Santiago de Compostela |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | University of Santiago de Compostela | Santiago de Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
University of Santiago de Compostela | Lacer, S.A. |
Spain,
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 |
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