Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods

NCT04518865 | Completed DMC

• 1 other identifier: Herbst azhar
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Malocclusion, Division 1

Keywords

Class II malocclusion.; prepubertal patients.; postpubertal patients.; Herbst appliance.

Outcome Measures

Primary Outcomes (1)

• Skeletal and dental changes

  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.

  8 months

Secondary Outcomes (1)

• Condylar head position

  8 months

Study Arms (2)

pre-pubertal group.

EXPERIMENTAL

The patients were allocated into the pre-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS II and CVMS III

Device: Herbst appliance

post-pubertal group

EXPERIMENTAL

The patients were allocated into the post-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS V and CVMS IV

Device: Herbst appliance

Interventions

Herbst appliance DEVICE

The bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT.

post-pubertal group; pre-pubertal group.

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Skletal Class I
• Craniofacial syndrome.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II; Overbite

Interventions

Orthodontic Appliances, Functional

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• khaled Farouk, lecturer

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start: October 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

EG (1)