Dental CariesNCT06135792
The Effect of Arginine on Biofilm Composition, Architecture and Metabolism
A study testing Arginine in people with Dental Caries and Dental Plaque, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries, Dental Plaque, Microbial Colonization
- What is being tested?
- Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Oct 2023to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Arginine on Biofilm Composition, Architecture and Metabolism in Caries-active Patients: a Split-mouth in Situ Trial
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
- Being tested
- Arginine, Placebo
- Medical subject headings
- Dental Caries, Dental Plaque, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineOther
See arm description
PlaceboOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biofilm pH
Extracellular biofilm pH measured after sucrose challenge using pH ratiometry
Measured: Measured after in situ biofilm growth
Secondary outcomes (3)
Biofilm microbial composition
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.
Measured: Analyzed after in situ biofilm growth
Biofilm matrix architecture
Matrix components are visualized in the dental biofilms by confocal microscopy.
Measured: Analyzed after of in situ biofilm growth
Biofilm thickness
Measured using confocal laser scanning microscopy and/or optical coherence tomography.
Measured: Measured after in situ biofilm growth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Oct 2023
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split-mouth design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Schlafer, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135792
- Sponsor's protocol ID
- 97473
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.
Publications
Del Rey YC, Rikvold PD, Lund MB, Raittio EJ, Schramm A, Meyer RL, Schlafer S. Arginine modulates the pH, microbial composition, and matrix architecture of biofilms from caries-active patients. Int J Oral Sci. 2025 Nov 20;17(1):70. doi: 10.1038/s41368-025-00404-5.
PubMed 41261098
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Arginine on Biofilm Composition, Architecture and Metabolism in Caries-active Patients: a Split-mouth in Situ Trial
- ClinicalTrials.gov ID
- NCT06135792
- Acronym / sponsor ID
- 97473
- Conditions
- Dental Caries, Dental Plaque, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Arginine solution | Experimental | Other: ArginineArginine 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArginineSee arm description | Other | Arginine solution |
| PlaceboSee arm description | Other | Placebo |
Primary outcome
Biofilm pH
Time frame: Measured after in situ biofilm growth
Extracellular biofilm pH measured after sucrose challenge using pH ratiometry
3 secondary outcomes
Biofilm microbial composition
Time frame: Analyzed after in situ biofilm growth
Biofilm matrix architecture
Time frame: Analyzed after of in situ biofilm growth
Biofilm thickness
Time frame: Measured after in situ biofilm growth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 41261098Del Rey YC, Rikvold PD, Lund MB, Raittio EJ, Schramm A, Meyer RL, Schlafer S. Arginine modulates the pH, microbial composition, and matrix architecture of biofilms from caries-active patients. Int J Oral Sci. 2025 Nov 20;17(1):70. doi: 10.1038/s41368-025-00404-5.
- Individual participant dataSharing planned: No. Due to general data protection regulations, individual participant data will not be made available publicly. Summary data will be made available upon publication of the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Schlafer principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine in people with Dental Caries and Dental Plaque, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm pH (time frame: Measured after in situ biofilm growth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.