Treatment of Unilateral Posterior Cross Bite in Children

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

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

Study Overview

• Status: Completed
• Conditions: Malocclusion; Maxillary Expansion; Pain Children
• Intervention / Treatment: Procedure: Maxillary expansion

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, SE-70111
    • Postgraduate Dental Education Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: Region Jönköping County
• Investigators: Study Director: Farhan Bazargani, DDS, PhD, Örebro University, Sweden

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 260581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No