Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children (NCT07671651) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children
Turkey (Türkiye)80 participantsStarted 2026-06-01
Plain-language summary
Initial caries lesions can be managed using non-invasive treatment approaches that promote remineralization and prevent lesion progression. Ozone therapy has been suggested as an adjunctive treatment because of its antimicrobial properties and its potential to enhance remineralization.
This randomized controlled clinical trial aims to evaluate the effect of ozone therapy on the remineralization of initial caries lesions in children. Participants will be randomly assigned to receive either ozone therapy followed by application of a remineralizing gel or application of the remineralizing gel alone.
Changes in lesion status will be assessed over time using clinical and optical evaluation methods. The results of this study may contribute to the development of evidence-based minimally invasive approaches for the management of early caries lesions in pediatric patients.
Who can participate
Age range
6 Years – 14 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:
Children aged 6-14 years. Patients attending the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry, for routine dental examination.
Presence of initial enamel caries lesions identified during clinical examination.
Systemically healthy individuals. Written informed consent obtained from a parent or legal guardian and assent obtained from the child.
Cooperative behavior rated as Frankl Behavior Rating Scale score 3 or 4.
Exclusion Criteria:
Presence of any systemic disease. Respiratory diseases that may contraindicate ozone therapy, including severe asthma.
Refusal of participation by the child or parent/legal guardian. Frankl Behavior Rating Scale score 1 or 2. Presence of enamel hypomineralization or enamel hypoplasia in teeth with initial caries lesions.
Failure to attend scheduled follow-up visits. Non-compliance with the prescribed remineralization gel application protocol. Withdrawal of consent or decision to discontinue participation during the study.
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 Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions