Molar Intrusion Using High Pull Headgear

NCT ID: NCT02951286

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Anterior Openbite

Study Design

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

Study Groups

high pull headgear + OBA

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.

Group Type: EXPERIMENTAL

high pull headgear + OBA

Intervention Type: DEVICE

a modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied in compination with a high pull headgear.

OBA (control group)

A modified version of the Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied only.

Group Type: EXPERIMENTAL

OBA (control group)

Intervention Type: DEVICE

A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied alone (Control group)

Interventions

high pull headgear + OBA

a modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied in compination with a high pull headgear.

Intervention Type: DEVICE

OBA (control group)

A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied alone (Control group)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with skeletal open bite determined by an increased B angle (angle between maxillary plane and mandibular plane), sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane).
• patients between 12 and 18 years old with permanent dentition stage.
• Negative over bite of more than a mm
• Class I and 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_DIRECTOR

Damascus University

Locations

Damascus University

Damascus, , Syria

Countries

Syria

References

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: RESULT

PMID: 21435540 (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: RESULT

PMID: 25531420 (View on PubMed)

Lee J, Miyazawa K, Tabuchi M, Kawaguchi M, Shibata M, Goto S. Midpalatal miniscrews and high-pull headgear for anteroposterior and vertical anchorage control: cephalometric comparisons of treatment changes. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):238-50. doi: 10.1016/j.ajodo.2013.03.020.

Reference Type: RESULT

PMID: 23910205 (View on PubMed)

Other Identifiers

UDDS-Ortho-02-2016

Identifier Type: -

Identifier Source: org_study_id