Molar Intrusion Using High Pull Headgear

December 31, 2017 updated by: Damascus University

Skeletal and Dentoalveolar Changes Following Posterior Teeth Intrusion With High Pull Headgear in The Treatment of Patients With Anterior Open Bite

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
a modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied in compination with a high pull headgear.
Experimental: OBA (control group)
A modified version of the Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied only.
A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied alone (Control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overbite
Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be abroximately after 7 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior facial height
Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
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
Molar intrusion
Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
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
Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
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
Change in the anteroposterior position of the point "B"
Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mohamad Yousef, DDS MSc PhD, Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

November 1, 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

Other Study ID Numbers

  • UDDS-Ortho-02-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will be available to all researchers in Damascus University

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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