Molar Intrusion in Open Bite Treatment

NCT ID: NCT02865213

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-11-30

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.

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.

Conditions

Anterior Open Bite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

OBA

Intervention Type: DEVICE

The intrusion of posterior teeth using removable appliance "OBA".

Miniplates

Intervention Type: DEVICE

The intrusion of posterior teeth using temporary anchorage "Miniplates".

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

Group Type: EXPERIMENTAL

OBA

Intervention Type: DEVICE

The intrusion of posterior teeth using removable appliance "OBA".

Miniscrews

Intervention Type: DEVICE

The intrusion of posterior teeth using temporary anchorage "Miniscrews".

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.

Group Type: EXPERIMENTAL

OBA

Intervention Type: DEVICE

The intrusion of posterior teeth using removable appliance "OBA".

Interventions

OBA

The intrusion of posterior teeth using removable appliance "OBA".

Intervention Type: DEVICE

Miniplates

The intrusion of posterior teeth using temporary anchorage "Miniplates".

Intervention Type: DEVICE

Miniscrews

The intrusion of posterior teeth using temporary anchorage "Miniscrews".

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamad Yousef, DDS MSc PhD

Role: STUDY_CHAIR

Damascus University

Locations

Damascus University

Damascus, , Syria

Countries

Syria

References

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.

Reference Type: BACKGROUND

PMID: 17169732 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12592995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21435540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21828357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17029531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15264651 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25531420 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15387036 (View on PubMed)

Other Identifiers

UDDS-Ortho-01-2016

Identifier Type: -

Identifier Source: org_study_id