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Molar Intrusion in Open Bite Treatment

Primary Purpose

Anterior Open Bite

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
OBA
Miniplates
Miniscrews
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Open Bite focused on measuring Open bite, Molar intrusion, Temporary anchorage devices

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 the maxillary plane and mandibular plane), the Sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane).
  • Patients between 12 and 18 years old in permanent dentition stage.
  • Negative over-bite of more than a mm
  • Class I or 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 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Miniplates + OBA

Miniscrews + OBA

Only OBA

Arm Description

The intrusion of posterior teeth using Miniplates + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniplates. The miniplates are for Jeil Dual top® anchor system, Jeil medical corporation, #702,kolon science valley 2nd, 811, Guro-Dong, Guro-Gu, Seoul, 152-050, Korea. Tel: 82.2.850.3500. Fax: 82.2.850.3537. homepage: www.jeilmed.co.kr/ E-mail: mktg@jeilmed.co.kr

The intrusion of posterior teeth using Miniscrews + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniscrews. The miniscrews are for Denxy ® dental orthodontic products, Denxy technology co, limited . 404,Lihuabuilding,Furongroad, Changsha, Hunan, China. Tel: 0086-731-89717339. Fax: 0086-731-82237315. Homepage: www.denxy-orthodontic.com/email: DENXYDENTALBOSS@126.COM

The intrusion of posterior teeth using OBA only will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth only.

Outcomes

Primary Outcome Measures

Overbite
The distance between the incisal edges of upper incisors and the incisal edges of the 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
July 22, 2016
Last Updated
December 31, 2017
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02865213
Brief Title
Molar Intrusion in Open Bite Treatment
Official Title
Assessment of Skeletal and Dentoalveolar Changes Resulting From Posterior Teeth Intrusion in Treatment of the Anterior Open Bite - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 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 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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Open Bite
Keywords
Open bite, Molar intrusion, Temporary anchorage devices

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Miniplates + OBA
Arm Type
Experimental
Arm Description
The intrusion of posterior teeth using Miniplates + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniplates. The miniplates are for Jeil Dual top® anchor system, Jeil medical corporation, #702,kolon science valley 2nd, 811, Guro-Dong, Guro-Gu, Seoul, 152-050, Korea. Tel: 82.2.850.3500. Fax: 82.2.850.3537. homepage: www.jeilmed.co.kr/ E-mail: mktg@jeilmed.co.kr
Arm Title
Miniscrews + OBA
Arm Type
Experimental
Arm Description
The intrusion of posterior teeth using Miniscrews + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniscrews. The miniscrews are for Denxy ® dental orthodontic products, Denxy technology co, limited . 404,Lihuabuilding,Furongroad, Changsha, Hunan, China. Tel: 0086-731-89717339. Fax: 0086-731-82237315. Homepage: www.denxy-orthodontic.com/email: DENXYDENTALBOSS@126.COM
Arm Title
Only OBA
Arm Type
Experimental
Arm Description
The intrusion of posterior teeth using OBA only will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth only.
Intervention Type
Device
Intervention Name(s)
OBA
Intervention Description
The intrusion of posterior teeth using removable appliance "OBA".
Intervention Type
Device
Intervention Name(s)
Miniplates
Intervention Description
The intrusion of posterior teeth using temporary anchorage "Miniplates".
Intervention Type
Device
Intervention Name(s)
Miniscrews
Intervention Description
The intrusion of posterior teeth using temporary anchorage "Miniscrews".
Primary Outcome Measure Information:
Title
Overbite
Description
The distance between the incisal edges of upper incisors and the incisal edges of the 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 approximately 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 the maxillary plane and mandibular plane), the Sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane). Patients between 12 and 18 years old in permanent dentition stage. Negative over-bite of more than a mm Class I or 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 Chair
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
No Individual participant data will be only available to the researchers in the department of Orthodontics, Damascus University
Citations:
PubMed Identifier
17169732
Citation
Ng J, Major PW, Flores-Mir C. True molar intrusion attained during orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2006 Dec;130(6):709-14. doi: 10.1016/j.ajodo.2005.05.049.
Results Reference
background
PubMed Identifier
12592995
Citation
Sugawara J, Baik UB, Umemori M, Takahashi I, Nagasaka H, Kawamura H, Mitani H. Treatment and posttreatment dentoalveolar changes following intrusion of mandibular molars with application of a skeletal anchorage system (SAS) for open bite correction. Int J Adult Orthodon Orthognath Surg. 2002;17(4):243-53.
Results Reference
background
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
background
PubMed Identifier
21828357
Citation
Akan S, Kocadereli I, Aktas A, Tasar F. Effects of maxillary molar intrusion with zygomatic anchorage on the stomatognathic system in anterior open bite patients. Eur J Orthod. 2013 Feb;35(1):93-102. doi: 10.1093/ejo/cjr081. Epub 2011 Aug 9.
Results Reference
background
PubMed Identifier
17029531
Citation
Xun C, Zeng X, Wang X. Microscrew anchorage in skeletal anterior open-bite treatment. Angle Orthod. 2007 Jan;77(1):47-56. doi: 10.2319/010906-14R.1.
Results Reference
background
PubMed Identifier
15264651
Citation
Erverdi N, Keles A, Nanda R. The use of skeletal anchorage in open bite treatment: a cephalometric evaluation. Angle Orthod. 2004 Jun;74(3):381-90. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
Results Reference
background
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
background
PubMed Identifier
15387036
Citation
Kuroda S, Katayama A, Takano-Yamamoto T. Severe anterior open-bite case treated using titanium screw anchorage. Angle Orthod. 2004 Aug;74(4):558-67. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
Results Reference
background

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Molar Intrusion in Open Bite Treatment

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