Treatment of Unilateral Posterior Cross Bite in Children

NCT04458506 | Completed

• 1 other identifier: 260581
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Malocclusion; Maxillary Expansion; Pain Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Assessment of the soft tissue changes

  At baseline, directly after expansion, six months and one year after expansion

• Evaluation of pain and discomfort

  Three times during the first week after inserting the appliances

• Evaluation of Temporomandibular Disorder (TMD)

  Baseline and one year after expansion

• Cost-effectiveness of two treatment modalities in treatment of posterior cross bite

  Through study completion, an average of 18 months

Study Arms (2)

Rapid Maxillary Expander (RME)

EXPERIMENTAL

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

Procedure: Maxillary expansion

Quad Helix (QH)

ACTIVE COMPARATOR

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

Procedure: Maxillary expansion

Interventions

Maxillary expansion PROCEDURE

Correction of the unilateral posterior cross bite in children

Quad Helix (QH); Rapid Maxillary Expander (RME)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children in the early mixed dentition
• Unilateral posterior cross bite including the first permanent molar

You may not qualify if:

• No ongoing sucking habits
• Craniofacial syndroms
• Earlier Orthodontic treatments
• Not able to independently understand and answer the questionnaires

Sponsors & Collaborators

• Region Örebro County: lead
• Region Jönköping County: collaborator

Study Sites (1)

Postgraduate Dental Education Center

Örebro, SE-70111, Sweden

Location

Related Publications (3)

• 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.

  PMID: 14580028 BACKGROUND

• Hansson S, Lindsten R, Josefsson E, Birk L, Ovsenik M, Petren S, Magnuson A, Bazargani F. Three-dimensional evaluation of palatal vault changes after unilateral posterior crossbite correction with quad helix or rapid maxillary expansion: A randomized controlled trial with 1-year follow-up. Int Orthod. 2026 Jan 12;24(2S):101136. doi: 10.1016/j.ortho.2025.101136. Online ahead of print.

  PMID: 41529457 DERIVED

• 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.

  PMID: 36331513 DERIVED

MeSH Terms

Conditions

Malocclusion

Interventions

Palatal Expansion Technique

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Study Officials

• Farhan Bazargani, DDS, PhD

  Örebro University, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 7, 2020
• Study Start: May 13, 2019
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 18, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)