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

Class II Malocclusion, Division 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518865
• Other study ID #: Herbst azhar
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: August 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Malocclusion, Division 1
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• Herbst appliance
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.

Locations

Country	Name	City	State
Egypt	Al-Azhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Condylar head position	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	8 months