Remineralization Agents for the Treatment of White Spot Lesions (NCT04827966) | Clinical Trial Compass
TerminatedNot Applicable
Remineralization Agents for the Treatment of White Spot Lesions
Stopped: Funding issues
Bahrain12 participantsStarted 2022-09-01
Plain-language summary
Clinically, formation of white spots can occur as early as 4 weeks into orthodontic treatment and very common in high caries risk individuals. When left untreated, the calcium loss continues, the enamel breaks down entirely, and a cavity appears. These can cause caries thereby leading to poor esthetics and patient dissatisfaction. The labio-gingival area of the lateral incisors is the most common site for WSL and the maxillary posterior segments are the least common site, with males affected more in comparison with females.Hence inducing remineralization of existing lesions is the key treatment to prevent cavitation.
Who can participate
Age range
18 Years
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:
* Adult patients attending the dental clinic for treatment of white spot lesions on their teeth
* using fluoride toothpaste once or twice daily for brushing
* does not use any other form of fluoride
* history of recent fixed orthodontic treatment
* presenting with white spot lesions on minimum of three anterior or posterior teeth on the labial surfaces
* provide written informed consent
Exclusion Criteria:
* Patients who do not fit into the above mentioned inclusion criteria.
* Patients who are allergic to milk or any other milk products will be excluded from the study. Milk protein allergy and lactose intolerance tests will be performed on participants belonging to active comparators Tooth Mousse and MI paste which contain casein phosphoprotein before enrolling them in the trial.
* Patients who are vegan and do not use or consume any animal products
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
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond
Timeframe: Baseline (before treatment)
2
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond
Timeframe: 3 weeks following treatment
3
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond
Timeframe: 6 weeks following treatment
4
Enamel decalcification score recorded using Enamel decalcification index (EDI) by Banker and Richmond