The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT06135792

Collaborator

(none)

Enrollment

Location

Arms

13.4

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Dental Plaque Microbial Colonization	Other: Arginine Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Split-mouth designSplit-mouth design

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 19, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Arginine See arm description
Placebo Comparator: 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.	Other: Placebo See arm description

Arm

Intervention/Treatment

Experimental: 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.

Other: Arginine

See arm description

Placebo Comparator: 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.

Other: Placebo

See arm description

Outcome Measures

Primary Outcome Measures

Biofilm pH [Measured after in situ biofilm growth]
Extracellular biofilm pH measured after sucrose challenge using pH ratiometry

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University	Aarhus		Denmark	8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator: Sebastian Schlafer, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT06135792

Other Study ID Numbers:

97473

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Communicable Diseases

Infections

Dental Caries

Dental Plaque

Study Results

No Results Posted as of Nov 18, 2023