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OpenTrials
Completed

NCT Number: NCT06135792

The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

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.

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Key information

Conditions

Dental Caries Communicable Diseases Dental Deposits Dental Plaque Disease Attributes Infections Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arginine

Other

See arm description

Placebo

Other

See arm description

Primary outcomes

  1. Biofilm pH

    Time frame: Measured after in situ biofilm growth

    Extracellular biofilm pH measured after sucrose challenge using pH ratiometry

Secondary outcomes

  1. Biofilm microbial composition

    Time frame: 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.

  2. Biofilm matrix architecture

    Time frame: Analyzed after of in situ biofilm growth

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

  3. Biofilm thickness

    Time frame: Measured after in situ biofilm growth

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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