MalocclusionNCT04458506
Treatment of Unilateral Posterior Cross Bite in Children
A study testing Maxillary expansion in people with Malocclusion and Maxillary Expansion, run by Region Örebro County at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Maxillary Expansion, Pain Children
- What is being tested?
- Maxillary expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- 13 May 2019to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in the early mixed dentition
- Unilateral posterior cross bite including the first permanent molar
Who cannot join
- No ongoing sucking habits
- Craniofacial syndroms
- Earlier Orthodontic treatments
- Not able to independently understand and answer the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Malocclusion, Maxillary Expansion, Pain Children
- Being tested
- Maxillary expansion
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary expansionProcedure or surgery
Correction of the unilateral posterior cross bite in children
| Study group | Role | What they receive |
|---|---|---|
| Rapid Maxillary Expander (RME) | Experimental | 36 patients will be treated with RME in order to correct their unilateral posterior cross bite Receives: Procedure: Maxillary expansion |
| Quad Helix (QH) | Active comparator | 36 patients will be treated with QH in order to correct their unilateral posterior cross bite Receives: Procedure: Maxillary expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline, directly after expansion and one year after expansion
Secondary outcomes (4)
Assessment of the soft tissue changes
3D assessment of the soft tissue changes during and after treatment by 3D -photography
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start13 May 2019
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jönköping County
- Responsible party
- Sponsor
- Investigators
- Farhan Bazargani, DDS, PhD, Study director, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458506
- Sponsor's protocol ID
- 260581
- Status last verified
- Apr 2022
- First submitted
- 23 Jun 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 14580028Hansson 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 Jun;24(2S):101136. doi: 10.1016/j.ortho.2025.101136. Epub 2026 Jan 12.
PubMed 41529457Hansson 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.
PubMed 36331513
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04458506
- Acronym / sponsor ID
- 260581
- Conditions
- Malocclusion, Maxillary Expansion, Pain Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Region Jönköping County
- Study start
- 13 May 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid Maxillary Expander (RME) | Experimental | Procedure: Maxillary expansion36 patients will be treated with RME in order to correct their unilateral posterior cross bite |
| Quad Helix (QH) | Active comparator | Procedure: Maxillary expansion36 patients will be treated with QH in order to correct their unilateral posterior cross bite |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children in the early mixed dentition
- Unilateral posterior cross bite including the first permanent molar
Key exclusion criteria (4 listed)
- No ongoing sucking habits
- Craniofacial syndroms
- Earlier Orthodontic treatments
- Not able to independently understand and answer the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillary expansionCorrection of the unilateral posterior cross bite in children | Procedure or surgery | Quad Helix (QH), Rapid Maxillary Expander (RME) |
Primary outcome
Skeletal expansion at the level of the palatal median suture - the change fram Baseline
Time frame: At baseline, directly after expansion and one year after expansion
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
Time frame: At baseline, directly after expansion and one year after expansion
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.
4 secondary outcomes
Assessment of the soft tissue changes
Time frame: At baseline, directly after expansion, six months and one year after expansion
Evaluation of pain and discomfort
Time frame: Three times during the first week after inserting the appliances
Evaluation of Temporomandibular Disorder (TMD)
Time frame: Baseline and one year after expansion
Cost-effectiveness of two treatment modalities in treatment of posterior cross bite
Time frame: Through study completion, an average of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 14580028Petren 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.
- Derived from this study: PubMed 41529457Hansson 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 Jun;24(2S):101136. doi: 10.1016/j.ortho.2025.101136. Epub 2026 Jan 12.
- Derived from this study: PubMed 36331513Hansson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhan Bazargani, DDS, PhD study director
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary expansion in people with Malocclusion and Maxillary Expansion, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal expansion at the level of the palatal median suture - the change fram Baseline (time frame: At baseline, directly after expansion and one year after expansion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04458506, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.