An interventional study of high pull headgear + OBA and OBA (control group) in Anterior Openbite, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-01-03.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
This prospective clinical study will evaluate the effect of high pull headgear for molar intrusion, compared with the control group, in adolescent patients with open bite malocclusion.
The study sample will consist of 24 patients with anterior open bite divided equally in two groups. The sample will be collected consecutively from patients attending the Orthodontic Department at Damascus university.
A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied for all patients. High pull headgears will be used in the first group, while, in the second (control) group, Open Bite Appliances will be used only.
The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be assessed by using posteroanterior and lateral cephalometric radiographs; pre- and post- treatment changes for each group will be evaluated.
Open bite malocclusion is considered one of the most difficult malocclusion to correct in orthodontic treatment because it appears as a result of different etiological factors such as genetic, dental, skeletal, functional, soft tissue, and habits that play roles in its development. Different treatment modalities used for the treatment of an anterior open bite. Multiloop edgewise archwires, miniscrews, high-pull headgear, and bite blocks have been used for anterior open bite patients, most open bite patients characterized by increased facial height, class II skeletal pattern, and vertical excess in maxillary posterior teeth.
Functional appliances, magnets, posterior bite blocks, and high pull headgear are used for posterior teeth intrusion. It is possible to generate intrusive force by using high pull headgear. Furthermore, direction of force can be changed according to the center of resistance of the dental units to achieve a better tooth movement control. The intrusion of posterior teeth will lead to decreased lower facial height by a counterclockwise rotation of the mandible; and improve class II skeletal relationship.
This study was the first clinical trial, that compare the effect of high pull headgear for molar intrusion with the control group in adolescent patients.
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 28 interventional studies indexed under Open Bite.
Browse Open Bite studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
A modified version of the Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied with high pull headgear for Orthoclassic ®1300 NE Alpha Drive, McMinnville, OR 97128 USA 866.752.0065.
Device: high pull headgear + OBA
A modified version of the Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied only.
Device: OBA (control group)
a modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied in compination with a high pull headgear.
A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied alone (Control group)
Overbite
The distance between the incisal edges of the upper and lower incisors, measured in mm.
Time frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be abroximately after 7 months.
Molar intrusion
The vertical distance between upper molars and the true horizontal plane (measured in mm)
Time frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
Mandibular autorotation
This variable will be measured by superimposition of the anterior cranial base
Time frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
Anterior facial height
The distance between the point "N" and the point "Me"
Time frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
Change in the anteroposterior position of the point "B"
The horizontal distance between point "B" and the true vertical plane
Time frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
Plan to share: No — The IPD will be available to all researchers in Damascus University
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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