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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Open Bite
• Intervention / Treatment: Device: OBA; Device: Miniplates; Device: Miniscrews

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, 00963
    • Damascus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Previous orthodontic treatment.
• Patients with syndromes, clefts, or craniofacial abnormalities.
• Class III skeletal anteroposterior relationship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Miniplates + OBA; 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; The intrusion of posterior teeth using removable appliance "OBA".; Device: Miniplates; The intrusion of posterior teeth using temporary anchorage "Miniplates".
Experimental: Miniscrews + OBA; 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; The intrusion of posterior teeth using removable appliance "OBA".; Device: Miniscrews; The intrusion of posterior teeth using temporary anchorage "Miniscrews".
Experimental: Only OBA; 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molar intrusion	The vertical distance between upper molars and the true horizontal plane (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
Mandibular autorotation	This variable will be measured by superimposition of the anterior cranial base.	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"	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.	This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Chair: Mohamad Yousef, DDS MSc PhD, Damascus University

Publications and helpful links

General Publications

• 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.
• Sugawara 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.
• Deguchi 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.
• Akan 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.
• Xun 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.
• Erverdi 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.
• Hart 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.
• Kuroda 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 31, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Temporary anchorage devices; Open bite; Molar intrusion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Open Bite
• Other Study ID Numbers: UDDS-Ortho-01-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

No

Individual participant data will be only available to the researchers in the department of Orthodontics, Damascus University