White Spot Lesions Treatment in Orthodontic (NCT06051981) | Clinical Trial Compass
UnknownPhase 4
White Spot Lesions Treatment in Orthodontic
88 participantsStarted 2023-10
Plain-language summary
The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic.
A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.
Who can participate
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
. Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
. Agreeing to participate in the study by singing the study informed consent.
. For younger patients parents agree to provide consent for child participation in the study.
Exclusion criteria
. Developmental defects of dental hard tissue
. Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
. Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration.
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
1
Change in mineral contents of enamel
Timeframe: Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)