Not Yet RecruitingNot Applicable

Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste

20 participantsStarted 2025-08-15

Plain-language summary

This study will be conducted to Clinically evaluate Bioactive Silica Based with calcium booster (Refix technology) toothpaste and Sodium Fluoride varnish versus conventional fluoride toothpastes in management of white spot lesions of adult patients over 6m follow up and evaluating patient perception regarding the treatment provided.

Who can participate

Age range

22 Years – 55 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 with non cavitated carious WSL in at least one upper or lower tooth. * Teeth with active non cavitated white spot carious lesions on the cervical one third of the facial or lingual surfaces. Teeth with initial carious lesions with score 1 or 2 according to The International Caries Detection and Assessment System (ICDAS). • Teeth with Diagnodent values between 14-20 that refers to early enamel caries. Exclusion Criteria: Patients with known allergies or adverse reactions to any ingredient of the tested materials. • Systematic disease and/ or physical disabilities that may affect participation. • Patients with white spots due to congenital reasons e.g. enamel hypomineralization. • Pregnant females with frequent vomiting attacks. • Smokers. • Excessive dietary or environmental exposure to acids. * Presence of surface cavitation or restorations .

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

Degree of Remineralization efficacy by Diagnodent

Timeframe: change from the baseline, 1month, 3 months , 6 months after treatment

Trial details

NCT IDNCT07120243

SponsorRawda Hesham Abd ElAziz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-15

Contact for this trial

Rawda Hesham Abd ElAziz

+201001097200 rawda.hesham@dentistry.cu.edu.eg

View on ClinicalTrials.gov More Caries; Initial trials