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

Not Applicable

Completed

• Conditions: Class II Malocclusion, Division 1
• Interventions: Device: Herbst appliance

• Registration Number: NCT04518865
• Lead Sponsor: Al-Azhar University

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 Timeline

• Study Start: 2017-10-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-04-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-16
• Last Update Submitted: 2020-08-16
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

1. Skletal Class I
2. Craniofacial syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-pubertal group.	Herbst appliance	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
post-pubertal group	Herbst appliance	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

Primary Outcome Measures

Name	Time	Method
Skeletal and dental changes	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 Outcome Measures

Name	Time	Method
Condylar head position	8 months	The Most middle-superior point of the mandibular condyle was determined in sagittal, axial and coronal views. In the sagittal slice of the middle condylar head, a line was drowned through the widest measurement of the condylar heads visible on the slice, from this line, three lines were raised crossing the glenoid fossa at 45°, 90°, and 135° . Four linear measurements representing the anterosuperior, superior, posterosuperior, and posterior distance were taken from the glenoid fossa wall to the surface of the condyle

Trial Locations

Locations (1)

Al-Azhar university; 🇪🇬 Cairo, Egypt