Dental Caries, Dental Plaque, Microbial Colonization
Conditions
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.
Interventions
OTHERArginine
See arm description
OTHERPlacebo
See arm description
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Split-mouth design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biofilm pH | Measured after in situ biofilm growth | Extracellular biofilm pH measured after sucrose challenge using pH ratiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed