Clinical Trial: Molar Intrusion Using High Pull Headgear

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Damascus University

Current Primary Outcome: 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.


Original Primary Outcome: 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 9 months. ]

The distance between the incisal edges of the upper and lower incisors, measured in mm.


Current Secondary Outcome:

  • 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)
  • 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
  • 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"
  • 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


Original Secondary Outcome:

  • 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 9 months ]
    The vertical distance between upper molars and the true horizontal plane (measured in mm)
  • 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 9 months ]
    This variable will be measured by superimposition of the anterior cranial base
  • 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 9 months ]
    The distance between the point "N" and the point "Me"
  • 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 9 months ]
    The horizontal distance between point "B" and the true vertical plane


Information By: Damascus University

Dates:
Date Received: October 28, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: February 17, 2017
Last Verified: February 2017