The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

University of Aarhus12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Dental Caries Dental Plaque Microbial Colonization

Interventions

ArginineOTHER

See arm description

PlaceboOTHER

See arm description

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Aarhus University

Aarhus, Denmark

Outcomes

Primary Outcomes

Biofilm pH

Extracellular biofilm pH measured after sucrose challenge using pH ratiometry

Time frame: Measured after in situ biofilm growth

Secondary Outcomes

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.

Time frame: Analyzed after in situ biofilm growth

Biofilm matrix architecture

Matrix components are visualized in the dental biofilms by confocal microscopy.

Time frame: Analyzed after of in situ biofilm growth

Biofilm thickness

Measured using confocal laser scanning microscopy and/or optical coherence tomography.

Time frame: Measured after in situ biofilm growth

Data from ClinicalTrials.gov

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