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Evaluation of the Effect of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid and MSE)
NA trial testing CH 4 band in Maxillary Retrusion in 54 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Al-Azhar University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 30 April 2022 |
| Primary completion | 19 November 2023 |
| Estimated completion | 20 June 2025 |
| Sites | 1 location across Egypt |
Al-Azhar University
Adults 11 to 18, any sex, with Maxillary Retrusion or Nasal Airway Obstruction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
distance in milimeter from mesiolingual cusp of upper first molar in one side to mesiolingual cusp of upper first molar in the other CBCT Measurements software
| Group | Value | 95% CI |
|---|---|---|
| Conventional Hyrax | 43.55 | ± 1.97 |
| Hybrid Hyrax | 44.79 | ± 4.27 |
| Maxillary Skeletal Expander | 42.14 | ± 3.25 |
amount of degree of Molar inclination change before and after maxillary expansion which measured from the long axis of upper first molar to palatal plane by CBCT Evaluation
| Group | Value | 95% CI |
|---|---|---|
| Conventional Hyrax | 5.66 | ± 1.52 |
| Hybrid Hyrax | 4.85 | ± 2.10 |
| Maxillary Skeletal Expander | 2.08 | ± 1.30 |
Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Conventional Hyrax | Hybrid Hyrax | Maxillary Skeletal Expander |
|---|---|---|---|---|
| metabolism | Metabolism and nutrition disorders | — | — | — |
| Reaction | System | Conventional Hyrax | Hybrid Hyrax | Maxillary Skeletal Expander |
|---|---|---|---|---|
| cardiac | Cardiac disorders | — | — | — |
Most-reported serious reactions: metabolism.
Data from ClinicalTrials.gov NCT05446714 adverse events section.
Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).
No peer-reviewed publications indexed yet for this trial.
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