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Clinical Trials/NCT04518865
NCT04518865
Completed
Not Applicable

Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods: A Cone Beam Computed Tomographic Study

Al-Azhar University1 site in 1 country36 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Class II Malocclusion, Division 1
Sponsor
Al-Azhar University
Enrollment
36
Locations
1
Primary Endpoint
Skeletal and dental changes
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty.

Detailed Description

Thirty-six Class II patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were treated with metallic splint supported Herbst IV appliance. Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
April 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

khaled farouk

lecturer

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • Skeletal Class II malocclusion with retrognathic mandible (ANB \>5°, SNB\<76°)
  • Normal growth pattern (SN/MP angle was in 25°- 35° range)
  • Unilateral or bilateral Class II molar relationship greater than or equal to one-half a cusp width.
  • Minimal or no crowding in the mandibular arch (0-5mm).
  • Average inclination or slight retroclination of the lower incisor.
  • An overjet greater than 5 mm.

Exclusion Criteria

  • Skletal Class I
  • Craniofacial syndrome.

Outcomes

Primary Outcomes

Skeletal and dental changes

Time Frame: 8 months

The DICOM (Digital Imaging and Communications in Medicine) files from the pre and post CBCT scans were imported to Mimics software (Version 10.1, Materialise NV, Leuven, Belgium); and the cephalometric landmarks and planes were defined . Linear sagittal measurements of point A, point B, glenoid fossa, upper incisor, lower incisor, upper molars, and lower molars were recorded in relation to orbital perpendicular plane.

Secondary Outcomes

  • Condylar head position(8 months)

Study Sites (1)

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