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NCT05466344

the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One

Completed Phase 2, PHASE3 Last updated 21 July 2022
What this trial tests

Phase 2, PHASE3 trial testing Herbst Group in Class II Malocclusion in 20 participants. Completed in 15 April 2022.

Timeline
15 June 2020
Primary endpoint
10 March 2022
15 April 2022

Quick facts

Lead sponsorAl-Azhar University
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment20
Start date15 June 2020
Primary completion10 March 2022
Estimated completion15 April 2022
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Al-Azhar University

Who can join

Adults 18 to 20, any sex, with Class II Malocclusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be directed to evaluate The effect of two different types of fixed functional appliances on the temporomandibular joint. Study design: Prospective randomized clinical study. Study setting and population: This study will be conducted on twenty orthodontic patients. The number of patients was dependent on a power study. Sample size calculation was based on the observed average effect size derived from previous article addressing "the effect of skeletally anchored Forsus FRD using miniplates for the treatment of Class II malocclusion

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Assessment of the condylar response of two differently anchored fixed functional appliances in class II malocclusion in young adult orthodontic patients: A randomized clinical trial.
    Abo-Elmahasen MMF, Elsaharty M, Abotaha NF, Mohamed AAS. · · 2024 · PMID 38516116 · DOI 10.4103/jos.jos_112_23

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Other trials of Herbst Group

Trials testing the same drug.

Other recruiting trials for Class II Malocclusion

Currently open trials in the same condition.

Other Al-Azhar University trials

Trials by the same sponsor.

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Data sources for this page

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