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Clinical Trials/NCT04518865
NCT04518865CompletedNot 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 enrollmentStarted: October 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Skeletal and dental changes

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
8 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

khaled farouk

lecturer

Al-Azhar University

Study Sites (1)

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