Active — Not RecruitingNot Applicable

Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary Teeth: A Randomized Clinical Trial

Turkey (Türkiye)90 participantsStarted 2025-10-01

Plain-language summary

Dental caries is a highly prevalent disease in children. Contemporary caries management emphasizes minimally invasive approaches that aim to arrest or reverse non-cavitated lesions rather than remove tooth structure. This randomized clinical trial aims to evaluate the effects of different remineralization agents on the progression of non-cavitated approximal carious lesions in primary teeth. The study will be conducted in children aged 4-10 years presenting with non-cavitated approximal carious lesions in primary molars. Participants will be randomly assigned to treatment groups receiving silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and/or 5% sodium fluoride (NaF) varnish. Materials will be applied according to manufacturers' instructions. Lesion progression will be assessed using standardized bitewing radiographs obtained at baseline and follow-up visits. Radiographic evaluations will be performed by blinded investigators. In addition, potential tooth color changes associated with the treatments will be quantitatively measured using a spectrophotometer based on the CIE Lab\* system at predefined follow-up intervals. The findings of this study are expected to provide clinically relevant evidence regarding the effectiveness and aesthetic outcomes of contemporary non-invasive caries management strategies in primary teeth.

Who can participate

Age range

4 Years – 10 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 4-10 years * Presence of at least two non-cavitated proximal caries lesions in primary teeth * Radiographic detection of lesions classified as E1, E2, or D1 * Absence of systemic disease * Cooperative patients * Written informed consent obtained from parents or legal guardians Exclusion Criteria: * Presence of restorations on study teeth * Deep dentin caries (D2 or D3) * Cavitated lesions * Uncooperative patients * Inability to attend follow-up visits

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

Radiographic progression of approximal caries lesions

Timeframe: 6 months and 12 months after intervention

Trial details

NCT IDNCT07431463

SponsorIzmir Katip Celebi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Dental Caries trials