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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Change in overjet; i.e change in tooth position during treatment. Assessment at follow up.
Study Overview
Brief 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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 3
Treatment FA
Intervention: FA (Device)
Group 1
Early treatment HGA (9 years)
Intervention: HGA (Device)
Group 1
Early treatment HGA (9 years)
Intervention: FA (Device)
Group 2
Late treatment HGA (11 years)
Intervention: FA (Device)
Group 2
Late treatment HGA (11 years)
Intervention: HGA (Device)
Outcomes
Primary Outcomes
Change in overjet; i.e change in tooth position during treatment. Assessment at follow up.
Time Frame: Through study completion (T0-T5), an average of two years between controls.
Tooth movement is assessed in millimeters by measures on study models.
Secondary Outcomes
- Change in Oral health related quality of life (OHRQoL)(Through study completion (T0-T5), an average of two years between controls.)
- Change in tooth position and skeletal growth.(Through study completion (T0-T5), an average of two years between controls.)
- Societal costs(During active treatment (T0-T3).)
Investigators
Jenny Kallunki
Senior Consultant Orthodontist. PhD-student
Region Östergötland