Back to resultsTreatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods
Primary Purpose
Class II Malocclusion, Division 1
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Herbst appliance
Sponsored by
About this trial
This is an interventional treatment trial for Class II Malocclusion, Division 1 focused on measuring Class II malocclusion., prepubertal patients., postpubertal patients., Herbst appliance.
Eligibility Criteria
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.
Sites / Locations
- Al-Azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
pre-pubertal group.
post-pubertal group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04518865
Brief Title
Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods
Official Title
Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods: A Cone Beam Computed Tomographic Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion, Division 1
Keywords
Class II malocclusion., prepubertal patients., postpubertal patients., Herbst appliance.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pre-pubertal group.
Arm Type
Experimental
Arm Description
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
Arm Title
post-pubertal group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Herbst appliance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skeletal and dental changes
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Condylar head position
Description
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
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khaled Farouk, lecturer
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods
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