Clinical trial NCT04458506: Treatment of Unilateral Posterior Cross Bite in Children
Official title: Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Maxillary Expansion
Pain Children
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Region Jönköping County
First posted: 2020-07-07
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Skeletal expansion at the level of the palatal median suture - the change fram Baseline
timeFrame: At baseline, directly after expansion and one year after expansion
measure: The change of inclination of teeth and alveolar bone and side effects between the time points
timeFrame: At baseline, directly after expansion and one year after expansion
Secondary outcomes:
measure: Assessment of the soft tissue changes
timeFrame: At baseline, directly after expansion, six months and one year after expansion
measure: Evaluation of pain and discomfort
timeFrame: Three times during the first week after inserting the appliances
measure: Evaluation of Temporomandibular Disorder (TMD)
timeFrame: Baseline and one year after expansion
measure: Cost-effectiveness of two treatment modalities in treatment of posterior cross bite
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Postgraduate Dental Education Center
Study officials:
affiliation: Örebro University, Sweden
name: Farhan Bazargani, DDS, PhD
role: STUDY_DIRECTOR
References:
citation: Petren S, Bondemark L, Soderfeldt B. A systematic review concerning early orthodontic treatment of unilateral posterior crossbite. Angle Orthod. 2003 Oct;73(5):588-96. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
citation: Hansson S, Josefsson E, Lindsten R, Magnuson A, Bazargani F. Pain and discomfort during the first week of maxillary expansion using two different expanders: patient-reported outcomes in a randomized controlled trial. Eur J Orthod. 2023 May 31;45(3):271-280. doi: 10.1093/ejo/cjac067.