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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06437262
Other study ID # 2021-CE161
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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