Orthodontic Treatment in Adolescents With Crowding and Displaced Teeth (NCT05664282) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Orthodontic Treatment in Adolescents With Crowding and Displaced Teeth
131 participantsStarted 2016-05-01
Plain-language summary
The purpose is to fill knowledge gaps identified for orthodontic treatment using a novel study design that has not been implemented in the dental field or in orthodontics. The study design comprises an analysis, where outcomes of two techniques are assessed at several efficacy levels by different methods. Moreover, the project is designed to include a longtime follow-up that is unique in orthodontic treatment. The aim is to compare two techniques with buccally fixed appliance in a multicenter RCT of adolescents aged 12 to 17 years with crowding and tooth displacement. In the intervention group, patients will be treated with a self-ligating bracket system, and in the control group with a conventional bracket system. Outcomes will be assessed from the clinical, patients' and economic perspectives as:
* Tooth alignment, function and adverse side effects
* Patients' perception of pain, function and quality of life
* Cost-effectiveness.
Who can participate
Age range
12 Years – 17 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.
The eligibility criteria were set as follows:
* Age at treatment start: 12-17 years
* Crowding and displaced teeth
* Maximum one cusp width deviation from normal sagittal relation
* Overbite ≥ 0 mm
* Normal or only dentoalveolar transversal discrepancy
* No missing permanent teeth up to first molars
* Treatment needed according to IOTN or ICON index and treated in accordance with the Swedish system of free child and youth dental care
The exclusion criteria were set as:
* Skeletal anomalies
* Rheumatoid arthritis
* Previous orthodontic treatment
* Impacted teeth
* Ongoing sucking habits
* Previous trauma to teeth or jaws with subjective, clinical, or radiographic signs: periapical pathology; probing depth ≥ 5 mm at ≥ 4 surfaces of central incisors or first molars
* Visible plaque grade 3
* Treatment plan including extractions or other appliances than fixed buccal appliances
* Communication difficulties.
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
Evaluating change in treatment outcomes at the clinical level
Timeframe: 2 years
2
Evaluating longitudinal change in treatment outcomes