Clinical Trial: Molar Intrusion in Open Bite Treatment

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

Official Title: Assessment of Skeletal and Dentoalveolar Changes Resulting From Posterior Teeth Intrusion in Treatment of the Anterior Open Bite - a Randomized Controlled Trial

Brief Summary:

This experimental study will evaluate the effect of different methods for the molar intrusion (compared with the control group) in adolescent and adult patients with open bite malocclusion. The study sample will consist of 45 patients with anterior open bite. The sample will be randomly allocated into two experimental groups, in addition to a control group.

The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be used in the first treatment group, while miniscrews will be used in the second treatment group. In the control group, only OBA will be used. 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, in addition to the comparison of the post-treatment skeletal and dental changes that occurs between groups.


Detailed Summary: Open bite malocclusion is considered one of the most difficult orthodontic problems to correct because it appears as a result of the interaction of numerous etiological factors (genetic, dental, skeletal, functional, soft tissue, and habit) that contribute to its development. Various therapeutic approaches have been proposed for the treatment of an anterior open bite. These approaches vary depending on the causative factors and involve myotherapy, preventive treatment, functional therapy, orthognathic surgery, and orthodontic treatment using anterior teeth extrusion or posterior teeth intrusion. Among the non-surgical orthodontic treatment methods are the temporary anchorage devices (TADs) including miniplates and miniscrew or micro-screw implants. The intrusion of posterior teeth with temporary anchorage devices was suggested to lead to decreased lower facial height by a counterclockwise rotation of the mandible; this may resemble the orthognathic surgery outcomes for any open bite patients. To the best of the investigators current knowledge, this is the first randomized controlled trial evaluating the effect of molar intrusion in adolescence and adult patients in the permanent dentition stage.
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 approximately after 7 months ]

The distance between the incisal edges of upper incisors and the incisal edges of the 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 approximately after 9 months ]

The distance between the incisal edges of upper incisors and the incisal edges of the 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: July 22, 2016
Date Started: January 2016
Date Completion: November 2017
Last Updated: February 17, 2017
Last Verified: February 2017