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Treatment of Unilateral Posterior Cross Bite in Children

Primary Purpose

Malocclusion, Maxillary Expansion, Pain Children

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Maxillary expansion
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Postgraduate Dental Education Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rapid Maxillary Expander (RME)

Quad Helix (QH)

Arm Description

36 patients will be treated with RME in order to correct their unilateral posterior cross bite

36 patients will be treated with QH in order to correct their unilateral posterior cross bite

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Assessment of the soft tissue changes
3D assessment of the soft tissue changes during and after treatment by 3D -photography
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.
Evaluation of Temporomandibular Disorder (TMD)
Questionnaire The questionnaire has no scale and the questions have a "Yes" och "No" nature.
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.

Full Information

First Posted
June 23, 2020
Last Updated
October 25, 2022
Sponsor
Region Örebro County
Collaborators
Region Jönköping County
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1. Study Identification

Unique Protocol Identification Number
NCT04458506
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
Collaborators
Region Jönköping County

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Maxillary Expansion, Pain Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapid Maxillary Expander (RME)
Arm Type
Experimental
Arm Description
36 patients will be treated with RME in order to correct their unilateral posterior cross bite
Arm Title
Quad Helix (QH)
Arm Type
Active Comparator
Arm Description
36 patients will be treated with QH in order to correct their unilateral posterior cross bite
Intervention Type
Procedure
Intervention Name(s)
Maxillary expansion
Intervention Description
Correction of the unilateral posterior cross bite in children
Primary Outcome Measure Information:
Title
Skeletal expansion at the level of the palatal median suture - the change fram Baseline
Description
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
Title
The change of inclination of teeth and alveolar bone and side effects between the time points
Description
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
Secondary Outcome Measure Information:
Title
Assessment of the soft tissue changes
Description
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
Title
Evaluation of pain and discomfort
Description
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
Title
Evaluation of Temporomandibular Disorder (TMD)
Description
Questionnaire The questionnaire has no scale and the questions have a "Yes" och "No" nature.
Time Frame
Baseline and one year after expansion
Title
Cost-effectiveness of two treatment modalities in treatment of posterior cross bite
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhan Bazargani, DDS, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Postgraduate Dental Education Center
City
Örebro
ZIP/Postal Code
SE-70111
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14580028
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.
Results Reference
background
PubMed Identifier
36331513
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.
Results Reference
derived

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Treatment of Unilateral Posterior Cross Bite in Children

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