Molar Intrusion in Open Bite Treatment
Assessment of Skeletal and Dentoalveolar Changes Resulting From Posterior Teeth Intrusion in Treatment of the Anterior Open Bite - a Randomized Controlled Trial
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJanuary 3, 2018
December 1, 2017
1.6 years
July 22, 2016
December 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overbite
The distance between the incisal edges of upper incisors and the incisal edges of the lower incisors, measured in mm
This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
Secondary Outcomes (4)
Molar intrusion
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 evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
Anterior facial height
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"
This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
Study Arms (3)
Miniplates + OBA
EXPERIMENTALThe 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
Miniscrews + OBA
EXPERIMENTALThe 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
Only OBA
EXPERIMENTALThe 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.
Interventions
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".
Eligibility Criteria
You may qualify if:
- Patients with skeletal open bite determined by an increased B angle (angle between the maxillary plane and mandibular plane), the Sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane).
- Patients between 12 and 18 years old in permanent dentition stage.
- Negative over-bite of more than a mm
- Class I or Class II skeletal anteroposterior relationship.
You may not qualify if:
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Class III skeletal anteroposterior relationship.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Damascus University
Damascus, 00963, Syria
Related Publications (8)
Ng J, Major PW, Flores-Mir C. True molar intrusion attained during orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2006 Dec;130(6):709-14. doi: 10.1016/j.ajodo.2005.05.049.
PMID: 17169732BACKGROUNDSugawara J, Baik UB, Umemori M, Takahashi I, Nagasaka H, Kawamura H, Mitani H. Treatment and posttreatment dentoalveolar changes following intrusion of mandibular molars with application of a skeletal anchorage system (SAS) for open bite correction. Int J Adult Orthodon Orthognath Surg. 2002;17(4):243-53.
PMID: 12592995BACKGROUNDDeguchi T, Kurosaka H, Oikawa H, Kuroda S, Takahashi I, Yamashiro T, Takano-Yamamoto T. Comparison of orthodontic treatment outcomes in adults with skeletal open bite between conventional edgewise treatment and implant-anchored orthodontics. Am J Orthod Dentofacial Orthop. 2011 Apr;139(4 Suppl):S60-8. doi: 10.1016/j.ajodo.2009.04.029.
PMID: 21435540BACKGROUNDAkan S, Kocadereli I, Aktas A, Tasar F. Effects of maxillary molar intrusion with zygomatic anchorage on the stomatognathic system in anterior open bite patients. Eur J Orthod. 2013 Feb;35(1):93-102. doi: 10.1093/ejo/cjr081. Epub 2011 Aug 9.
PMID: 21828357BACKGROUNDXun C, Zeng X, Wang X. Microscrew anchorage in skeletal anterior open-bite treatment. Angle Orthod. 2007 Jan;77(1):47-56. doi: 10.2319/010906-14R.1.
PMID: 17029531BACKGROUNDErverdi N, Keles A, Nanda R. The use of skeletal anchorage in open bite treatment: a cephalometric evaluation. Angle Orthod. 2004 Jun;74(3):381-90. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
PMID: 15264651BACKGROUNDHart TR, Cousley RR, Fishman LS, Tallents RH. Dentoskeletal changes following mini-implant molar intrusion in anterior open bite patients. Angle Orthod. 2015 Nov;85(6):941-8. doi: 10.2319/090514-625.1. Epub 2014 Dec 22.
PMID: 25531420BACKGROUNDKuroda S, Katayama A, Takano-Yamamoto T. Severe anterior open-bite case treated using titanium screw anchorage. Angle Orthod. 2004 Aug;74(4):558-67. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
PMID: 15387036BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohamad Yousef, DDS MSc PhD
Damascus University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2016
First Posted
August 12, 2016
Study Start
January 1, 2016
Primary Completion
August 1, 2017
Study Completion
November 1, 2017
Last Updated
January 3, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share
No Individual participant data will be only available to the researchers in the department of Orthodontics, Damascus University