Treatment of Unilateral Posterior Cross Bite in Children

NCT ID: NCT04458506

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2022-11-01

Brief Summary

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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

Detailed Description

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Conditions

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Malocclusion Maxillary Expansion Pain Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rapid Maxillary Expander (RME)

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

Group Type EXPERIMENTAL

Maxillary expansion

Intervention Type PROCEDURE

Correction of the unilateral posterior cross bite in children

Quad Helix (QH)

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

Group Type ACTIVE_COMPARATOR

Maxillary expansion

Intervention Type PROCEDURE

Correction of the unilateral posterior cross bite in children

Interventions

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Maxillary expansion

Correction of the unilateral posterior cross bite in children

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Jönköping County

OTHER_GOV

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farhan Bazargani, DDS, PhD

Role: STUDY_DIRECTOR

Örebro University, Sweden

Locations

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Postgraduate Dental Education Center

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 14580028 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36331513 (View on PubMed)

Other Identifiers

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260581

Identifier Type: -

Identifier Source: org_study_id

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