An interventional study of Herbst appliance in Class II Malocclusion, Division 1, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-19.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
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.
455 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 36 is close to the median of 36 across 371 interventional studies indexed under Malocclusion.
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Exclusion Criteria:
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 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.
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.
Time frame: 8 months
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
Time frame: 8 months
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Al-Azhar University