An interventional study of HGA and FA in Class II Malocclusion, Division 1, Orthodontic Appliances and Quality of Life, sponsored by Jenny Kallunki. Active, not recruiting at 1 site in Sweden. Open to participants aged 8 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Jenny Kallunki · Not applicable, Interventional, and Treatment
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:
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)
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's enrollment of 96 is above the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →This is the only study on the registry with Jenny Kallunki as lead sponsor.
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Exclusion Criteria:
Early treatment HGA (9 years)
Device: HGA · Device: FA
Late treatment HGA (11 years)
Device: HGA · Device: FA
Treatment FA
Device: FA
Headgear Activator
Fixed Orthodontic Appliance
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.
Time frame: Through study completion (T0-T5), an average of two years between controls.
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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion (T0-T5), an average of two years between controls.
Plan to share: No
Started Dec 2013 (actual). Primary completion is estimated for Dec 2030, 204 months after the start.
Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's planned 204 months is above that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class II →