Treatment of Class II Malocclusion With Excessive Overjet

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants (children, 9 years of age) are recruited at the orthodontic specialist clinic in Norrköping, Sweden. After informed consent participants are randomized into Group 1, 2 or 3. After randomization and registration, treatment with HGA is initiated for Group 1. Group 2 and 3 serves as untreated control group. Two years after registration, Group 2 starts treatment with HGA at the age of eleven. Group 3 serves as untreated control group to treatment with HGA. Four years after registration, Group 3 starts treatment with FA (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription). The patients in group 1 and 2 in need of a second phase of orthodontic treatment are treated with FA (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription) in early adolescence. The following registrations are made: Study models, photographs (extraoral, intraoral), Lateral head radiographs (T0, T2, T5, if required T1, T3), Child perceptions questionnaire. T0: After randomization; before treatment start (Group 1), registration/control (Group 2,3). T1: Two years after T0; after finished treatment for (Group 1), before treatment start (Group 2), control/registration for (Group 3). T2: Two years after T1; follow up (Group 1), after finished treatment (Group 2), before treatment start (Group 3). T3: Approx two years after T2 for patients not undergoing treatment with FA. For patients treated with FA, when treatment is finished. T4: Approx two years after T3- follow up. T5: Approx 8-10 years after T0 (Long term follow-up)

Official Title
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Early and Late Treatment of Class II Malocclusion With Excessive Overjet- a Randomized Controlled Trial Regarding Treatment Results, Patient Experience and Treatment and Cost-effectiveness

Conditions
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Class II Malocclusion, Division 1, Orthodontic Appliances, Quality of Life, Costs and Cost Analysis

Intervention / Treatment
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* Device: HGA
* Device: FA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Early treatment HGA (9 years) | Device: HGA<br>* Headgear Activator<br>Device: FA<br>* Fixed Orthodontic Appliance<br>|
| Active Comparator: Group 2<br>Late treatment HGA (11 years) | Device: HGA<br>* Headgear Activator<br>Device: FA<br>* Fixed Orthodontic Appliance<br>|
| Active Comparator: Group 3<br>Treatment FA | Device: FA<br>* Fixed Orthodontic Appliance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overjet; i.e change in tooth position during treatment. Assessment at follow up. | Tooth movement is assessed in millimeters by measures on study models. | Through study completion (T0-T5), an average of two years between controls. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oral health related quality of life (OHRQoL) | Oral health related quality of life is assessed by the use of the Child Perceptions Questionnaire where 0 is minimal and 148 is maximum. Higher scores corresponds to poorer OHRQoL. | Through study completion (T0-T5), an average of two years between controls. | 
| Societal costs | Societal costs are the sum of indirect and direct treatment costs. Indirect treatment costs are travel costs for the patient and cost for parents when accompaning patients during treatment. Direct costs are clinical costs due to personnel and material. | During active treatment (T0-T3). | 
| Change in tooth position and skeletal growth. | Tooth movement is assessed in millimeters by measures on study models. Skeletal growth is assessed in length and angular measures by cephalometric analysis of lateral radiographs. | Through study completion (T0-T5), an average of two years between controls. |