Actively Recruiting
Remineralization Potential of Different Agents on Initial Enamel Caries: Laboratory and Two-year Clinical Trial
Led by Mansoura University · Updated on 2025-08-13
120
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of four different remineralizing agents on early enamel caries (white spot lesions) in young patients over a two-year period. This study is designed as a double-blinded, randomized clinical trial following CONSORT guidelines, involving patients aged 14 to 26 seeking dental treatment at a university clinic. The goal is to compare how well these agents help manage initial enamel caries on permanent teeth surfaces. Participants are randomly assigned to one of four treatment groups receiving different remineralizing agents: SAP fluoride plus, 10% nano-hydroxyapatite (n-HAp), 10% nano-bioactive glass (n-BAG), or Flour Protector S varnish. Treatments vary by agent; some are applied once at baseline, others weekly for four weeks, or at baseline and six months. Teeth are prepared by cleaning and isolation before application, and patients receive instructions on oral hygiene and diet to support treatment. Throughout the study, participants are assessed at baseline and at 3, 6, 12, and 24 months using ICDAS II scores and DIAGNOdent measurements to monitor changes in enamel caries. Follow-ups include clinical exams to evaluate the enamel surface condition and caries progression. The total participation duration is two years, during which patient adherence to instructions and safety are monitored to understand the agents' remineralizing potential.
CONDITIONS
Brief Title
Clinical Evaluation of Remineralizing Potential of Remineralizing Agents on WSLs Managment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants should have at least one visible initial enamel caries in permanent teeth
- Only lesions with ICDAS II score of 1 or 2 can be included
- Patients must have good oral hygiene
You will not qualify if you...
- Patients using tetracyclines or any medication known to stain teeth
- Patients who had fluoride application less than 3 months before the study
- Teeth with microcavities or dentinal involvement due to enamel loss
- Teeth with discoloration, enamel hypoplasia, or fluorosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive one of several remineralizing agents applied to initial enamel caries on permanent teeth. Depending on the agent, treatments occur either once at baseline or weekly for four weeks, with instructions on oral hygiene and dietary restrictions.
1 to 4 treatment visits depending on assigned agent
Duration - 24 months
Participants are monitored over two years to assess the effectiveness of the remineralizing agents on enamel caries through periodic dental assessments.
Visits at 3, 6, 12, and 24 months after baseline
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Mansoura University, Egypt
Al Mansurah, Egypt
Actively Recruiting
Research Team
T
Tarek A Arisha, Ass Lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here