Treatment of Unilateral Posterior Cross Bite in Children

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458506
• Other study ID #: 260581
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2022
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Maxillary Expansion
• Pain Children

Intervention

Procedure:
• Maxillary expansion
Correction of the unilateral posterior cross bite in children

Locations

Country	Name	City	State
Sweden	Postgraduate Dental Education Center	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	Region Jönköping County

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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