Color Masking Potential of Bioactive and ICON Materials (NCT06402500) | Clinical Trial Compass
UnknownNot Applicable
Color Masking Potential of Bioactive and ICON Materials
Jordan75 participantsStarted 2023-12-01
Plain-language summary
The non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. It is an efficient material in arresting WSLs and has high favorable esthetic recovery. Furthermore, biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. The hypotheses of this study are:
1. There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration.
2. There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON.
Who can participate
Age range
12 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
. Anterior and premolar maxillary and mandibular teeth.
. Teeth with no previous restorations.
. post-orthodontic white spot lesions WSL with no adjacent restorations in the same tooth.
. WSL on Labial surfaces of maxillary or mandibular anterior and premolars teeth.
Exclusion criteria
. Cavitated enamel surface that requires direct composite restorations.
. Presence of developmental enamel defects on the proposed teeth.
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
Color masking potential of ICON material in white spot lesions in permanent teeth.
Timeframe: 6 months
2
Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.