The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

Not Applicable

Completed

• Conditions: Dental Plaque; Dental Caries; Microbial Colonization
• Interventions: Other: Arginine; Other: Placebo

• Registration Number: NCT06135792
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-19
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Primary Completion: 2024-02-13
• Study Completion: 2024-02-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arginine solution	Arginine	Arginine treatment is performed outside the oral cavity (ex vivo) by immersing one side of a splint into a solution of arginine 1.5% (w/v). Treatment is performed 3 times a day for 30 min.
Placebo	Placebo	Placebo treatment is performed outside the oral cavity (ex vivo) by immersing one side of a splint into distilled water. Treatment is performed 3 times a day for 30 min.

Primary Outcome Measures

Name	Time	Method
Biofilm pH	Measured after in situ biofilm growth	Extracellular biofilm pH measured after sucrose challenge using pH ratiometry

Secondary Outcome Measures

Name	Time	Method
Biofilm microbial composition	Analyzed after in situ biofilm growth	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.
Biofilm thickness	Measured after in situ biofilm growth	Measured using confocal laser scanning microscopy and/or optical coherence tomography.
Biofilm matrix architecture	Analyzed after of in situ biofilm growth	Matrix components are visualized in the dental biofilms by confocal microscopy.

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus, Denmark