Investigating fluoride varnishes for treating white spot lesions in orthodontic patients
The Effect of Light-cured Fluoride Varnish to Remineralize Post-orthodontic White Spot Lesions and Change the Oral Microbiome: a Double-blind, Split-mouth Randomized Clinical Trial
This study is testing different fluoride varnishes to see which one works best for treating white spot lesions in young people finishing their braces treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 27 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04528134 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of different fluoride varnishes in treating white spot lesions that develop during orthodontic treatment. It will involve 120 participants aged 12-27 who are nearing the end of their orthodontic treatment with metal braces. Using a split-mouth design, each participant will receive two different treatments on opposite sides of their mouth, including a placebo varnish, traditional sodium fluoride varnish, and a resin-modified glass ionomer varnish. The study will assess oral health through questionnaires, plaque visualization, and microbiome analysis.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 12-17 who are nearing the end of orthodontic treatment and have visible white spot lesions.
Not a fit: Patients who do not have white spot lesions or are not undergoing orthodontic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatments for preventing dental caries and improving oral health in orthodontic patients.
How similar studies have performed: Previous studies have shown promising results with fluoride varnishes in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females, 12-17 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 * Presence of xerostomia (dry mouth).
Where this trial is running
Los Angeles, California
- UCLA School of Dentistry — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Tyler Brennan, DDS — University of California, Los Angeles
- Study coordinator: Tyler A Brennan, DDS
- Email: tylerabrennan@g.ucla.edu
- Phone: 2089850444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.