Skip to main content
OpenTrials
Completed

NCT Number: NCT02951286

Molar Intrusion Using High Pull Headgear

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Openbite

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00963, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

OBA (control group)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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"

  4. 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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.