WithdrawnNot Applicable

12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

Stopped: Organisational and regulatory challenges.

0Started 2019-12

Plain-language summary

Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.

Who can participate

Age range

10 Years – 12 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: * Questionable, Very mild, and Mild (Dean's Index) dental fluorosis as well as TF scale grades 1, 2, and 3 of the upper anterior teeth. * Parents of children who accept and commit to the informed consent letter collaborate with the study taking their children to each of the scheduled follow ups. Exclusion Criteria: * Teeth without fluorosis. * Teeth with hypoplasia. * Teeth with incipient caries lesions observed at gingival level and differentiated by the Presence of plaque. * Teeth previously restored or with aesthetic corrective treatments * Teeth with endodontic treatment. * Patients with low or questionable hygiene. * Malnourished patients or that have some underlying disease. * Teeth with less than two thirds of its visible crown. * Children that have less than six teeth in their oral cavity. * Allergic reaction to methylmethacrylate.

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

action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel

Timeframe: immediate after treatment

Trial details

NCT IDNCT02925780

SponsorDMG Dental Material Gesellschaft mbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06

View on ClinicalTrials.gov More Fluorosis trials

Who can participate

Age range

10 Years – 12 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.