Malocclusion, Maxillary Expansion, Pain Children
Conditions
Brief summary
Rapid maxillary expansion and quad-helix are two well established appliances in dentistry used for posterior cross bite treatment. This study aims to compare this two different appliances in patients in their early mixed dentition, regarding treatment effects of the extra oral soft tissue but also dental and skeletal effects, if the children experience any pain and discomfort during treatment and the study also aims to make a cost minimization analysis. Comparison of these different treatments are barely made and no randomized controlled trial is yet published. No study has evaluated the difference of subjective experience during these two treatments. After this study we will know which one of these two appliances are the most effective, regarding cost minimization and treatment result but we are also able to put it in relation to the patients subjective experience
Interventions
PROCEDUREMaxillary expansion
Correction of the unilateral posterior cross bite in children
Sponsors
Region Jönköping County
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Children in the early mixed dentition * Unilateral posterior cross bite including the first permanent molar
Exclusion criteria
* No ongoing sucking habits * Craniofacial syndroms * Earlier Orthodontic treatments * Not able to independently understand and answer the questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal expansion at the level of the palatal median suture - the change fram Baseline | At baseline, directly after expansion and one year after expansion | Skeletal expansion evaluated by computed tomography at three time points in both arms. The change in width of the palatal median suture is going to be evaluated and compared to the Baseline values, in both arms. |
| The change of inclination of teeth and alveolar bone and side effects between the time points | At baseline, directly after expansion and one year after expansion | Dental effects and side effects evaluated by computed tomography at three time points in both arms.The change in degree of angulation and inclination of the dental structures (e.g. tooth inclinations) is going to be evaluated and compared to the Baseline values, in both arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the soft tissue changes | At baseline, directly after expansion, six months and one year after expansion | 3D assessment of the soft tissue changes during and after treatment by 3D -photography |
| Evaluation of pain and discomfort | Three times during the first week after inserting the appliances | Questionnaire The Questionnaire has some questions with Visual Analogue Scale. With the minimum value of 0 and maximum value of 10. Higher values mean worse outcome. Other questions in the questionnaire have a yes and No nature. |
| Evaluation of Temporomandibular Disorder (TMD) | Baseline and one year after expansion | Questionnaire The questionnaire has no scale and the questions have a Yes och No nature. |
| Cost-effectiveness of two treatment modalities in treatment of posterior cross bite | Through study completion, an average of 18 months | Evaluation of both the direct and indirect costs of the treatment, number of emergency visits, treatment duration (in total) etc are going to be evaluated. |
Countries
Sweden
Outcome results
None listed