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NCT04884022

Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients

Status unknown NA Last updated 27 July 2022
What this trial tests

NA trial testing Miniplates in mandibular symphysis & infrazygomatic in Malocclusion in 39 participants. Status unknown.

Timeline
8 March 2021
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorAlexandria University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment39
Start date8 March 2021
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Malocclusion

Currently open trials in the same condition.

Other Alexandria University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing