Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis… (NCT01733888) | Clinical Trial Compass
CompletedNot Applicable
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
India80 participantsStarted 2013-07
Plain-language summary
Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development.
The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin infiltration is a novel method that has shown its efficacy in improving the esthetics of various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ and in-vivo studies. The Resin Infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions.
Therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and Resin infiltration therapy in children with fluorosed teeth.
Who can participate
Age range
6 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:
* Only the non-pitted Fluorosis opacities shall be included for this purpose; opacities in anterior teeth shall be classified according to Russell's criteria for differentiating fluoride and non- fluoride opacities
* Subjects classified /Teeth classified with dental fluorosis of 1-4 according to Thylstrup, Fejerskov classification of dental fluorosis 20
* Patients who will be willing to participate in the study and who will be accepting for recall visit.
Exclusion Criteria:
* History of allergy towards any dental material.
* Teeth classified as non-fluoride opacities
* Subjects with any systemic and local conditions not permitting the treatment
* Subjects who had undergone any treatment for dental fluorosis earlier
* Subjects with direct or indirect restorations in maxillary central or lateral incisors.
* Subjects not willing to participate in the study
* Subjects with fractured teeth maxillary central or lateral incisors.
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.