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

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

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.

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion, Division 1
• Intervention / Treatment: Device: Herbst appliance

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pre-pubertal group.; 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; 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.
Experimental: post-pubertal group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: khaled Farouk, lecturer, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Class II malocclusion.; prepubertal patients.; postpubertal patients.; Herbst appliance.
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: Herbst azhar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No