An interventional study of OBA and Miniplates in Anterior Open Bite, 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 experimental study will evaluate the effect of different methods for the molar intrusion (compared with the control group) in adolescent and adult patients with open bite malocclusion. The study sample will consist of 45 patients with anterior open bite. The sample will be randomly allocated into two experimental groups, in addition to a control group.
The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be used in the first treatment group, while miniscrews will be used in the second treatment group. In the control group, only OBA will be used. 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, in addition to the comparison of the post-treatment skeletal and dental changes that occurs between groups.
Open bite malocclusion is considered one of the most difficult orthodontic problems to correct because it appears as a result of the interaction of numerous etiological factors (genetic, dental, skeletal, functional, soft tissue, and habit) that contribute to its development. Various therapeutic approaches have been proposed for the treatment of an anterior open bite. These approaches vary depending on the causative factors and involve myotherapy, preventive treatment, functional therapy, orthognathic surgery, and orthodontic treatment using anterior teeth extrusion or posterior teeth intrusion. Among the non-surgical orthodontic treatment methods are the temporary anchorage devices (TADs) including miniplates and miniscrew or micro-screw implants. The intrusion of posterior teeth with temporary anchorage devices was suggested to lead to decreased lower facial height by a counterclockwise rotation of the mandible; this may resemble the orthognathic surgery outcomes for any open bite patients. To the best of the investigators current knowledge, this is the first randomized controlled trial evaluating the effect of molar intrusion in adolescence and adult patients in the permanent dentition stage.
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 45 is above 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:
The intrusion of posterior teeth using Miniplates + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniplates. The miniplates are for Jeil Dual top® anchor system, Jeil medical corporation, #702,kolon science valley 2nd, 811, Guro-Dong, Guro-Gu, Seoul, 152-050, Korea. Tel: 82.2.850.3500. Fax: 82.2.850.3537. homepage: www.jeilmed.co.kr/ E-mail: mktg@jeilmed.co.kr
Device: OBA · Device: Miniplates
The intrusion of posterior teeth using Miniscrews + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniscrews. The miniscrews are for Denxy ® dental orthodontic products, Denxy technology co, limited . 404,Lihuabuilding,Furongroad, Changsha, Hunan, China. Tel: 0086-731-89717339. Fax: 0086-731-82237315. Homepage: www.denxy-orthodontic.com/email: DENXYDENTALBOSS@126.COM
Device: OBA · Device: Miniscrews
The intrusion of posterior teeth using OBA only will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth only.
Device: OBA
The intrusion of posterior teeth using removable appliance "OBA".
The intrusion of posterior teeth using temporary anchorage "Miniplates".
The intrusion of posterior teeth using temporary anchorage "Miniscrews".
Overbite
The distance between the incisal edges of upper incisors and the incisal edges of the 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 approximately 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 — No Individual participant data will be only available to the researchers in the department of Orthodontics, 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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