Active — Not RecruitingNot Applicable

Treatment of Class II Malocclusion With Excessive Overjet

Sweden96 participantsStarted 2013-12-05

Plain-language summary

Class II malocclusion with excessive overjet is one of the most common malocclusions among children and adolescents. The overall goal of the project is to analyze orthodontic treatment of Class II malocclusion with excessive overjet when the treatment is started in different ages and treated with removable and/or fixed appliance. Treatment initiated before the age of eleven is performed with a removable functional appliance, Headgear Activator (HGA). Treatment starting in early adolescence is performed with fixed orthodontic appliance (FA). The hypotheses are: * Treatment with HGA at the age of nine or eleven is effective. No spontaneous correction of the malocclusion is expected in the untreated control group. * Patient experience, treatment effect and cost-effectiveness are equivalent whether the treatment with HGA is initiated at the age of nine or eleven. * Treatment results, patient experience and treatment- and cost-effectiveness are equivalent whether treatment is initiated early with HGA or initiated in early adolescence with FA. * The treatment of Class II malocclusion with excessive overjet renders long-term treatment stability and patient satisfaction.

Who can participate

Age range

8 Years – 10 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: * Eight to ten years of age at the start of the trial * mixed dentition; * Excessive overjet (≥ 6 mm) and first maxillary permanent molars in Class II malocclusion * No sucking habits or ceased sucking habits should have been evident at least one year before the trial was started. Exclusion Criteria: * Craniofacial syndromes * Previous orthodontic treatment * Severe crowding of teeth, i.e. making the extraction of teeth necessary

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

Change in overjet; i.e change in tooth position during treatment. Assessment at follow up.

Timeframe: Through study completion (T0-T5), an average of two years between controls.

Trial details

NCT IDNCT04508322

SponsorJenny Kallunki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12

View on ClinicalTrials.gov More Class II Malocclusion, Division 1 trials