An interventional study of Maxillary expansion in Malocclusion, Maxillary Expansion and Pain Children, sponsored by Region Örebro County. Completed at 1 site in Sweden. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Region Örebro County · Not applicable, Interventional, and Treatment
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
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 72 is above the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Region Örebro County is the lead sponsor of 123 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
36 patients will be treated with RME in order to correct their unilateral posterior cross bite
Procedure: Maxillary expansion
36 patients will be treated with QH in order to correct their unilateral posterior cross bite
Procedure: Maxillary expansion
Correction of the unilateral posterior cross bite in children
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.
Time frame: 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.
Time frame: At baseline, directly after expansion and one year after expansion
Assessment of the soft tissue changes
3D assessment of the soft tissue changes during and after treatment by 3D -photography
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 18 months
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Region Örebro County