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| Name | Class |
|---|---|
| Region Östergötland | OTHER |
| Malmö University | OTHER |
| Eklund foundation Malmö | UNKNOWN |
| Swedish Dental Associations Scientific Funds |
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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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Early treatment HGA (9 years) |
|
| Group 2 | Active Comparator | Late treatment HGA (11 years) |
|
| Group 3 | Active Comparator | Treatment FA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGA | Device | Headgear Activator |
| |
| FA |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny Kallunki, Orthodontist | Malmö University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Orthodontics and Pedodontics | Norrköping | Östergötland County | 60182 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29534303 | Background | Batista KB, Thiruvenkatachari B, Harrison JE, O'Brien KD. Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents. Cochrane Database Syst Rev. 2018 Mar 13;3(3):CD003452. doi: 10.1002/14651858.CD003452.pub4. | |
| 25214504 | Background | Dimberg L, Arnrup K, Bondemark L. The impact of malocclusion on the quality of life among children and adolescents: a systematic review of quantitative studies. Eur J Orthod. 2015 Jun;37(3):238-47. doi: 10.1093/ejo/cju046. Epub 2014 Sep 11. |
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| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| UNKNOWN |
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| Device |
Fixed Orthodontic Appliance |
|
| 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. |
| 14614414 | Background | O'Brien K, Wright J, Conboy F, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I, Berk NW. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 2: Psychosocial effects. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):488-94; discussion 494-5. doi: 10.1016/S0889540603006425. |
| 15646914 | Background | Jokovic A, Locker D, Tompson B, Guyatt G. Questionnaire for measuring oral health-related quality of life in eight- to ten-year-old children. Pediatr Dent. 2004 Nov-Dec;26(6):512-8. |
| 12161456 | Background | Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Validity and reliability of a questionnaire for measuring child oral-health-related quality of life. J Dent Res. 2002 Jul;81(7):459-63. doi: 10.1177/154405910208100705. |
| 29878165 | Result | Kallunki J, Sollenius O, Paulsson L, Petren S, Dimberg L, Bondemark L. Oral health-related quality of life among children with excessive overjet or unilateral posterior crossbite with functional shift compared to children with no or mild orthodontic treatment need. Eur J Orthod. 2019 Mar 29;41(2):111-116. doi: 10.1093/ejo/cjy033. |
| 33274388 | Result | Kallunki J, Bondemark L, Paulsson L. Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial. Eur J Orthod. 2021 Dec 1;43(6):639-647. doi: 10.1093/ejo/cjaa073. |
| 34041527 | Result | Kallunki J, Bondemark L, Paulsson L. Comparisons of costs and treatment effects-an RCT on headgear activator treatment of excessive overjet in the mixed and late mixed dentition. Eur J Orthod. 2022 Jan 25;44(1):86-94. doi: 10.1093/ejo/cjab026. |