Orthodontic Varnish Microbiology Study
Dental Caries, Dental Plaque, Dental White Spot
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Orthodontics
Eligibility Criteria
Inclusion Criteria:
- Males and females, 12-19 years of age, inclusive, at the time the Assent and Informed Consent Form is signed
- Systemically healthy, as determined by the investigator (in consultation with the Medical Monitor, as needed), based on medical history, concurrent illnesses, laboratory results, concomitant medications, oral cavity assessment, and targeted physical examination (extraoral, head and neck) during screening
- Is approaching the end of their orthodontic treatment using metal fixed oral appliances (brackets) on at least the maxillary arch
- Subject has at least two visible white spot lesions at the time of recruitment on teeth treated with fixed oral appliances
- Subject is willing to use only oral care products that fall within the standard of care (manual toothbrush and sodium fluoride toothpaste) for the duration of the study.
- Subject is willing to postpone dental cleanings between the baseline and final visit (since subjects will receive cleanings 6 months apart at both the baseline and final visit, the standard of care will be maintained).
- Subject is willing and able to comply with oral hygiene and diet instructions.
- Subject is able to understand and sign the Assent and/or Informed Consent Form prior to initiation of study procedures
- Subject is able to communicate with the Investigator/study personnel, understand and comply with the study requirements, and is willing to return for protocol-specified visits at the appointed times.
Exclusion Criteria:
- Advanced periodontal disease
- Medical condition (e.g. artificial heart valve, history of infective endocarditis, cardiac transplant with valvular dysfunction, congenital heart disease or total joint replacement) for which antibiotics are recommended prior to dental visits and/or procedures
- Pathologic lesions of the oral cavity (suspected or confirmed)
- Use of systemic antibiotics, topical oral antibiotics, or use of other drugs, which in the opinion of the investigators could influence the study outcome, within 30 days prior to screening.
- Presence of any condition or concurrent illness, which in the opinion of the investigators, would compromise normal immune function ((e.g., diabetes, rheumatoid arthritis, lupus, liver disease, organ transplant, etc.), interfere with the use of study dentifrice and oral care products, or interfere with the ability to comply with study requirements, or jeopardize the safety of the subject or the validity of the study results
Sites / Locations
- UCLA School of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Extended Contact RMGI Varnish/5% Sodium Fluoride Varnish
Placebo Varnish/Extended Contact RMGI Varnish
5% Sodium Fluoride Varnish/Placebo Varnish
This group will receive extended contact (XT) varnish on their upper left and lower right teeth, and traditional 5% sodium fluoride varnish on their upper right and lower left teeth.
This group will receive placebo varnish on their upper left and lower right teeth, and extended contact (XT) varnish on their upper right and lower left teeth.
This group will receive traditional 5% sodium fluoride varnish on their upper left and lower right teeth, and placebo varnish on their upper right and lower left teeth.