Treatment of Unilateral Posterior Cross Bite in Children

Study Overview
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Brief Summary
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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

Official Title
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Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial

Conditions
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Malocclusion, Maxillary Expansion, Pain Children

Intervention / Treatment
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* Procedure: Maxillary expansion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid Maxillary Expander (RME)<br>36 patients will be treated with RME in order to correct their unilateral posterior cross bite | Procedure: Maxillary expansion<br>* Correction of the unilateral posterior cross bite in children<br>|
| Active Comparator: Quad Helix (QH)<br>36 patients will be treated with QH in order to correct their unilateral posterior cross bite | Procedure: Maxillary expansion<br>* Correction of the unilateral posterior cross bite in children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal expansion at the level of the palatal median suture - the change fram Baseline | 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. | At baseline, directly after expansion and one year after expansion | 
| The change of inclination of teeth and alveolar bone and side effects between the time points | 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. | At baseline, directly after expansion and one year after expansion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the soft tissue changes | 3D assessment of the soft tissue changes during and after treatment by 3D -photography | At baseline, directly after expansion, six months and one year after expansion | 
| Evaluation of pain and discomfort | 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. | Three times during the first week after inserting the appliances | 
| Evaluation of Temporomandibular Disorder (TMD) | Questionnaire The questionnaire has no scale and the questions have a Yes och No nature. | Baseline and one year after expansion | 
| Cost-effectiveness of two treatment modalities in treatment of posterior cross bite | 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. | Through study completion, an average of 18 months |