Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement (NCT04538963) | Clinical Trial Compass
UnknownNot Applicable
Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement
United States38 participantsStarted 2020-09-03
Plain-language summary
The purpose of this study is to evaluate the efficacy of using orthodontic bands with glass ionomer cement to arrest or reverse interproximal lesions as a preventive treatment compared to monitoring and oral hygiene.
The investigators hypothesize that placing orthodontic bands with glass ionomer cement will arrest and possibly remineralize incipient carious lesions compared to teeth that are being monitored without intervention.
Who can participate
Age range
5 Years – 209 Months
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:
* Healthy children
* Children or adolescents (Age 5\<17.5yrs) who have erupted permanent teeth that make interproximal contact with other teeth, either primary or permanent teeth.
* Presence of at least one pair of interproximal carious lesions (E1, E2, early D1 according to the ADA CCS), evaluated by radiographic analysis, on permanent premolars or molars that do not require surgical intervention. If multiple pairs of lesions are present, they may be included in the study as well.
Exclusion criteria
* Patients who will be undergoing orthodontic treatment in the following 12 months.
* Patients with a poor behavior rating at their dental visit, defined with a (--) designation in behavior note
* Patients noted to have severe plaque levels and generalized severe gingivitis.
* Teeth with advanced caries into dentin that require surgical intervention restoration (Mid D1-D3). Dental needs that are required will be completed by the primary dental provider in the Dental Clinic
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
Radiographic Assessment of Interproximal Carious lesions