The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

NCT06135792 | Completed

• 1 other identifier: 97473
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Dental Plaque; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• Biofilm pH

  Extracellular biofilm pH measured after sucrose challenge using pH ratiometry

  Measured after in situ biofilm growth

Secondary Outcomes (3)

• Biofilm microbial composition

  Analyzed after in situ biofilm growth

• Biofilm matrix architecture

  Analyzed after of in situ biofilm growth

• Biofilm thickness

  Measured after in situ biofilm growth

Study Arms (2)

Arginine solution

EXPERIMENTAL

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.

Other: Arginine

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Arginine OTHER

See arm description

Arginine solution

Placebo OTHER

See arm description

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Dental Caries; Dental Plaque; Communicable Diseases

Interventions

Arginine

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Sebastian Schlafer

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth design

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: October 19, 2023
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)