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NCT04458506
Treatment of Unilateral Posterior Cross Bite in Children
NA trial testing Maxillary expansion in Malocclusion in 72 participants. Completed in 1 November 2022.
1 October 2022
Quick facts
| Lead sponsor | Region Örebro County |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 13 May 2019 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 November 2022 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Maxillary expansion
Conditions studied
- Malocclusion — all drugs for Malocclusion →
- Maxillary Expansion — all drugs for Maxillary Expansion →
- Pain Children — all drugs for Pain Children →
Sponsor
Region Örebro County — full company profile →
Who can join
Adults 8 to 13, any sex, with Malocclusion or Maxillary Expansion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pain and discomfort during the first week of maxillary expansion using two different expanders: patient-reported outcomes in a randomized controlled trial.
Hansson S, Josefsson E, Lindsten R, Magnuson A, et al · · 2023 · cited 9× · PMID 36331513 · DOI 10.1093/ejo/cjac067 -
Posterior crossbite corrections in the early mixed dentition with quad helix or rapid maxillary expander: a cost-effectiveness analysis of a randomized controlled trial.
Hansson S, Johansson N, Lindsten R, Petrén S, et al · · 2024 · cited 2× · PMID 38808562 · DOI 10.1093/ejo/cjae028 -
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.
Hansson S, Lindsten R, Josefsson E, Birk L, et al · · 2026 · PMID 41529457 · DOI 10.1016/j.ortho.2025.101136 -
Skeletal effects of posterior crossbite treatment with either quad helix or rapid maxillary expansion: a randomized controlled trial with 1-year follow-up.
Hansson S, Josefsson E, Lund H, Miranda-Bazargani S, et al · · 2024 · PMID 39230018 · DOI 10.2319/010424-9.1
Verify or expand the search:
- PubMed search for NCT04458506
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Maxillary expansion
Trials testing the same drug.
- NCT05629312 — Effect of Interceptive Strategies on the Clinical Outcome of Maxillary Impacted Canines · NA · completed
Other recruiting trials for Malocclusion
Currently open trials in the same condition.
- NCT05684510 — Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy · NA · recruiting
- NCT07290790 — A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSm · NA · recruiting
- NCT06858670 — Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars · NA · recruiting
- NCT06536335 — Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings · NA · recruiting
- NCT07094581 — Evaluation of the Effect of Adenoid Hypertrophy on the Masseter Muscle in Children: A Comparative Ultrasonographic Study · recruiting
Other Region Örebro County trials
Trials by the same sponsor.
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- NCT07206147 — Physical Exercise as Treatment Post-stroke Fatigue - a Feasibilty Study. · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04458506 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Region Örebro County
- Last refreshed: 18 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04458506.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing