CompletedNot Applicable

The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

Denmark12 participantsStarted 2023-10-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Biofilm pH

Timeframe: Measured after in situ biofilm growth

Trial details

NCT IDNCT06135792

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-13

View on ClinicalTrials.gov More Dental Caries trials