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The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

NCT ID: NCT06135792

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2024-02-13

Brief Summary

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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

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Conditions

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Dental Caries Dental Plaque Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split-mouth design
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arginine solution

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.

Group Type EXPERIMENTAL

Arginine

Intervention Type OTHER

See arm description

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

See arm description

Interventions

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Arginine

See arm description

Intervention Type OTHER

Placebo

See arm description

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Schlafer

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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97473

Identifier Type: -

Identifier Source: org_study_id