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NCT04884022
Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients
NA trial testing Miniplates in mandibular symphysis & infrazygomatic in Malocclusion in 39 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | Alexandria University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 8 March 2021 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Miniplates in mandibular symphysis & infrazygomatic
- Miniplates in external oblique ridge & anterior maxillary region
Conditions studied
- Malocclusion — all drugs for Malocclusion →
Sponsor
Alexandria University
Who can join
Adults 11 to 13, any sex, with Malocclusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups. first group will be treated by pushing orthopedic force mechanics, second group will be treated by pulling orthopedic force mechanics, and third group will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated and the treatment changes will be compared with the natural growth changes. The study hypothesis is that use of direct bimaxillary miniplate anchorage in conjunction with fixed functional appliance (pushing orthopedic force) or closed coil spring (pulling orthopedic force) will induce statistically significant skeletal mandibular growth in comparison to natural mandibular growth changes.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparison between two bone anchored force systems for correction of skeletal Class II malocclusion in growing patients: a randomized controlled clinical trial, part 1: short-term skeletal changes.
Mahmoud YM, Abdel-Haffiez SH, Marzouk ES, El Ashwah AA, et al · · 2025 · cited 1× · PMID 41015417 · DOI 10.2319/111324-934.1 -
Comparison between two bone anchored force systems for correction of skeletal Class II malocclusion in growing patients: a randomized controlled clinical trial, part 2: short-term dentoalveolar changes.
Mahmoud YM, Marzouk ES, El Ashwah AA, Ismail HA, et al · · 2025 · PMID 41412156 · DOI 10.2319/111324-935.1
Verify or expand the search:
- PubMed search for NCT04884022
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04884022 (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 Alexandria University
- Last refreshed: 27 July 2022
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/NCT04884022.
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