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Molar Intrusion Using High Pull Headgear

Primary Purpose

Anterior Openbite

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
high pull headgear + OBA
OBA (control group)
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Openbite focused on measuring Skeletal openbite, Molar intrusion, high pull headgear

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

high pull headgear + OBA

OBA (control group)

Arm Description

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 Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Molar intrusion
The vertical distance between upper molars and the true horizontal plane (measured in mm)
Mandibular autorotation
This variable will be measured by superimposition of the anterior cranial base
Anterior facial height
The distance between the point "N" and the point "Me"
Change in the anteroposterior position of the point "B"
The horizontal distance between point "B" and the true vertical plane

Full Information

First Posted
October 28, 2016
Last Updated
December 31, 2017
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02951286
Brief Title
Molar Intrusion Using High Pull Headgear
Official Title
Skeletal and Dentoalveolar Changes Following Posterior Teeth Intrusion With High Pull Headgear in The Treatment of Patients With Anterior Open Bite
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Openbite
Keywords
Skeletal openbite, Molar intrusion, high pull headgear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high pull headgear + OBA
Arm Type
Experimental
Arm Description
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.
Arm Title
OBA (control group)
Arm Type
Experimental
Arm Description
A modified version of the Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied only.
Intervention Type
Device
Intervention Name(s)
high pull headgear + OBA
Intervention Description
a modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied in compination with a high pull headgear.
Intervention Type
Device
Intervention Name(s)
OBA (control group)
Intervention Description
A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied alone (Control group)
Primary Outcome Measure Information:
Title
Overbite
Description
The distance between the incisal edges of the upper and lower incisors, measured in mm.
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.
Secondary Outcome Measure Information:
Title
Molar intrusion
Description
The vertical distance between upper molars and the true horizontal plane (measured in mm)
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
Title
Mandibular autorotation
Description
This variable will be measured by superimposition of the anterior cranial base
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
Title
Anterior facial height
Description
The distance between the point "N" and the point "Me"
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
Title
Change in the anteroposterior position of the point "B"
Description
The horizontal distance between point "B" and the true vertical plane
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Yousef, DDS MSc PhD
Organizational Affiliation
Damascus University
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will be available to all researchers in Damascus University
Citations:
PubMed Identifier
21435540
Citation
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.
Results Reference
result
PubMed Identifier
25531420
Citation
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.
Results Reference
result
PubMed Identifier
23910205
Citation
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.
Results Reference
result

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Molar Intrusion Using High Pull Headgear

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