Compliance, Patient, Treatment Adherence
Conditions
Keywords
Orthodontic, Removable, Compliance, Adherence, Twin Block
Brief summary
To compare the effect of two control intervals (once every 4th week or once every 6th week) on the wear time of a Twin Block removable appliance.
Detailed description
If the patient fulfill the inclusion criteria, they will be asked to participate in the study. After being informed about the study and the planned treatment, participants and their guardians will give their written consent to participate in the study. Therafter they will be consecutively randomized into one of two groups with different control intervals, Group 1 (every 4th week) and Group 2 (every 6th week). They will recieve a clinical and radiological examination and then start treatment with a Twin Block appliance. The Twin Block appliance will be fitted with a digital timer module to measure the wear time of the appliance objectively.
Interventions
DEVICETwin block
Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure
Sponsors
Region Jönköping County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor will check outcome on blinded study models.
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Healthy patients (ASA 1 and 2) * Overjet of 6 mm or more * Incomplete lip closure
Exclusion criteria
* Severe chronic conditions such as asthma or allergies * Neuroopsychiatric disorders * Craniofacial syndromes * Previous orthodontic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals | From randomization to 12 months of treatment | To measure if the wear time of the Twin Block appliance would increase if the control interval increased from once every 6th week to once every 4th week. The wear time was registered using the TheraMon system, and was measured in hours per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in overjet, compared between participants randomized into two groups with different check up intervals | From randomization to treatment completion, up to 24 months. | To see if change in overjet would differ between or within the groups before and after treatment was finished. Horizontal overjet was measured in millimetres on study casts before and after treatment was finished. |
| Change in overbite, compared between participants randomized into two groups with different check up intervals | From randomization to treatment completion, up to 24 months. | To see if change in overbite would differ between or within the groups before and after treatment. Overbite was measured in millimetres on study casts taken before and after treatment. |
| Change in molar relationship, compared between participants randomized into two groups with different check up intervals | From randomization to treatment completion, up to 24 months. | To see how molar relationship would be differ between or within the two groups before and after treatment, measured in Angle classification on study casts before and after treatment completion. |
Countries
Sweden
Outcome results
None listed