Color Stability of S-PRG Resin-Based Light-Cure Varnish and Prophylaxis Paste on White Spot Lesions (NCT07126366) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Color Stability of S-PRG Resin-Based Light-Cure Varnish and Prophylaxis Paste on White Spot Lesions
58 participantsStarted 2025-09-21
Plain-language summary
The aim of the study is to evaluate and compare the long-term color stability of two bioactive materials used in the management of white spot lesions: Surface Pre-Reacted Glass (S-PRG) containing resin-based light-cured varnish and S-PRG containing prophylaxis paste. The study will assess color changes over a 12-month period to determine which material better maintains aesthetic integrity while providing therapeutic benefits for demineralized enamel surfaces.
Who can participate
Age range
16 Years – 35 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:
* Patient consulting in the outpatient clinic.
* Enamel caries in anterior permanent teeth according to ICDAS-1 and ICDAS-2.
* Good oral hygiene.
* Provide informed consent.
* Cooperative and willing to participate in the trial.
* Male or female.
* Adult patients aged 16 to 35 years.
Exclusion Criteria:
* Spontaneous or elicited pain from caries.
* Tooth mobility.
* Signs of pulpal infection.
* Severe medical conditions that would not allow management in the clinic.
* Hereditary developmental defects such as amelogenesis imperfecta or dentinogenesis imperfecta.
* Known allergies or sensitivities to dental materials, including fluoride
* Inability to return for recall visits.
* Poor oral hygiene.
* Refusal to participate in 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
Visual assessment using ICDAS criteria at baseline, 3, 6, and 12 months
Timeframe: at baseline, 3 months, 6 months and 12 months