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NCT06135792 Clinical Trial

The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

Dental Caries Clinical Trial

Official title:
The Effect of Arginine on Biofilm Composition, Architecture and Metabolism in Caries-active Patients: a Split-mouth in Situ Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06135792
Other study ID # 97473
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 19, 2023
Est. completion date December 2024

Study information
Verified date November 2023
Source University of Aarhus
Contact Yumi Chokyu Del Rey
Phone 87167400
Email yumi@dent.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Arginine is an adjunct to oral health care that has the potential to modulate the composition and activity of the microbial community of dental biofilms towards a health-related status without harmful effects for the resident oral microbiota. The aim of the study is to investigate the effects of arginine treatment compared to placebo on the composition, metabolism, and microarchitecture of biofilms grown in situ in the oral cavity of caries-active participants.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males and females = 18 years old. - Three or more active carious lesions. - Anatomically possible to manufacture an intraoral lower-jaw splint. - Able to understand and follow instructions, as well as to read and sign the informed consent form. Exclusion Criteria: - History of allergies towards any of the ingredients in the test products - Self-reported pregnant or nursing - Antibiotic or anti-inflammatory medication within 90 days of the screening visit. - Orthodontic appliances, including retainers, or removable partial dentures. - Self-reported serious medical conditions.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Arginine
See arm description
• Placebo
See arm description

Locations
Country Name City State
Denmark Aarhus University Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biofilm pH Extracellular biofilm pH measured after sucrose challenge using pH ratiometry Measured after in situ biofilm growth
Secondary Biofilm microbial composition Microbial community of dental biofilms determined by 16S rRNA gene sequencing. Distribution of specific microbial targets in the biofilms is visualized by fluorescence in situ hybridization. Analyzed after in situ biofilm growth
Secondary Biofilm matrix architecture Matrix components are visualized in the dental biofilms by confocal microscopy. Analyzed after of in situ biofilm growth
Secondary Biofilm thickness Measured using confocal laser scanning microscopy and/or optical coherence tomography. Measured after in situ biofilm growth
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