Molar Intrusion Using High Pull Headgear

NCT02951286 | Completed DMC

• 1 other identifier: UDDS-Ortho-02-2016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Openbite

Keywords

Skeletal openbite; Molar intrusion; high pull headgear

Outcome Measures

Primary Outcomes (1)

• Overbite

  The distance between the incisal edges of the upper and 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 abroximately 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 (2)

high pull headgear + OBA

EXPERIMENTAL

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.

Device: high pull headgear + OBA

OBA (control group)

EXPERIMENTAL

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

Device: OBA (control group)

Interventions

high pull headgear + OBA 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.

high pull headgear + OBA

OBA (control group) DEVICE

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

OBA (control group)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related Publications (3)

• 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.

  PMID: 21435540 RESULT

• 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.

  PMID: 25531420 RESULT

• 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.

  PMID: 23910205 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mohamad Yousef, DDS MSc PhD

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)