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Early Treatment of Skeletal Anterior Open Bite by Two Appliances

Primary Purpose

Open Bite

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Bionator
Removable Appliance with Posterior Bite Planes
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Bite

Eligibility Criteria

7 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anterior open bite (2-10) mm.
  • Skeletal Class I or II malocclusion.
  • MP-SN angle ranged between (33-45) degrees.
  • MM angle ranged between (27-37) degrees.
  • Age between 7.5-10.5 years.

Exclusion Criteria:

  • Patients who had an old orthodontic treatment
  • People with a syndrome or congenital deformity

Sites / Locations

  • Orthodontic Department, University of Al-Baath Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bionator

Removable Appliance with Posterior Bite Planes

Arm Description

The modified Bionator was used to correct the open bite malocclusion. Patients were asked to wear the appliance every day.

A removable appliance with poster bite planes was used to correct the open bite malocclusion. Patients were asked to wear this appliance full time expect eating times.

Outcomes

Primary Outcome Measures

Change in the SNA angle
This angle represents the position of upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and A.
Change in the SNB angle
This anglrepresents the position of lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and B.
Change in the ANB angle
This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between A, N, and B.
Changes in the MM angle
This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the maxillary plane and mandibular plane.
Changes in the SN-OCP angle
This angle represents the relationship between the occlusion plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the SN plane (anterior cranial base plane) and the OCP (occlusal) plane.
Changes in the SN-MP angle
This angle represents the relationship between the lower jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the mandibular plane (MP plane).
Changes in the SN-SPP angle
This angle represents the relationship between the upper jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the maxillary plane (SPP plane).
Changes in the overbite (Ovb)
This is a vertical measurement done on the cephalometric tracings in millimeters. It is the vertical overlap between the upper incisors and the lower incisors.
Changes in the overjet (Ovj)
This is a horizontal measurement done on the cephalometric tracings in millimeters. It is the amount of protrusion of upper incisors in relation to the lower incisors.
Changes in the Bjork sum
Lateral cephalograms will be taken twice and this measurement is the sum of three different angles: (N-S-Ar + S-Ar-Go +Ar-Go-Me). These angles are well-known to orthodontists.
Changes in the N-A-Pog angle
Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between three points: N, A, and Pogonion (Pog). N is located on the nasal bone. A is located at the maximum concavity of the anterior upper alveolus between the central incisors. Pog is the located at the most prominent point on the chin contour.
Changes in the UI- LI angle
This angle represents the relationship between the upper and the lower incisor axes in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the long axis of the upper incisor and the long axis of the lower incisor.
Changes in the NS-GN angle
This angle represents the growth pattern of the mandible in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (NS plane) and the the Y-axis plane (i.e. the facial axis plane defined by two points: Sella Point and Gnathion 'Gn' Point).
Changes in the posterior facial height (S-Go)
This will be vertically measured in millimeters from S point to Go point. 'S' point referes to Sella Turcica point. 'Go' point refers to the gonial angle point (located at the corner of the mandibular ramus).
Changes in the anterior facial height (N-Me)
This will be vertically measured in millimeters from N point to Me point. 'N' point refers to the Nasion point. 'Me' point refers to the Menton point (located at the lower border of the chin).
Changes in the 'NasoLab' angle
This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the lower nasal tangent (i.e. the plane that touches the lower border of the columella), and the upper lip plane (i.e. the plane that goes through points Subnasale and Labrale Superius).
Changes in the 'MentoLab' angle
This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between two planes: the lower lip tangent plane (from 'Labrale inferius' to mentolabial point) and upper anterior chin plane (from mentolabial point to Pogonion point).

Secondary Outcome Measures

Full Information

First Posted
April 4, 2020
Last Updated
April 7, 2020
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT04338217
Brief Title
Early Treatment of Skeletal Anterior Open Bite by Two Appliances
Official Title
Evaluation of the Open-bite Bionator Versus the Removable Posterior Bite Plane With a Tongue Crib in the Early Treatment of Skeletal Anterior Open Bite: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open bite is a common dentoalveolar component of the facial pattern of the excessive vertical dimension patients that is also known as the gaping angle face pattern.It is a deformation in the vertical relationship between the upper and the lower dental arches that is characterized by the loss of contact between the opposite dental segments.
Detailed Description
An open bite develops as a result of the interaction of many etiologic factors, both hereditary and environmental. Prolonged sucking habits and hyper-divergent facial characteristics are significant risk factors for an anterior open bite in the mixed dentition. Abnormal tongue posture (frequently associated with enlarged adenoids or tonsils) and tongue thrust also can be involved in the establishment of alveolar and skeletal discrepancies concurrent with vertical problems Two types of an open bite are recognized in this profession: (1) dentoalveolar open bite: the abnormality formalities aspects limiting in the dental and alveolar region, usually associated with abnormal function habits as the thumb sucking and (2) Skeletal open bite: that's associated with an over high of the lower facial vertical dimension and a large plane angle of the lower jaw. open bites associated with excessive vertical skeletal dimensions are difficult to treat and tend to relapse The investigators must be recognized between the dentoalveolar open bite and the open bite caused by formalities disorders and the position disorders of the upper or the lower jaw or both. Dental an open bite can be corrected by itself if the treatment was beginning early and it's responding Easley to the mechanical treatment methods and the functional treatment approaches that depending on the muscular activity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Bite

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bionator
Arm Type
Experimental
Arm Description
The modified Bionator was used to correct the open bite malocclusion. Patients were asked to wear the appliance every day.
Arm Title
Removable Appliance with Posterior Bite Planes
Arm Type
Active Comparator
Arm Description
A removable appliance with poster bite planes was used to correct the open bite malocclusion. Patients were asked to wear this appliance full time expect eating times.
Intervention Type
Device
Intervention Name(s)
Bionator
Intervention Description
This is a functional appliance that is used to overcome the functional problems and to correct the open bite deformity
Intervention Type
Device
Intervention Name(s)
Removable Appliance with Posterior Bite Planes
Intervention Description
This is a one-jaw appliance that is used in conjunction with a tongue crib to control the faulty positions of the tongue and to help in closing the open bite through the use of posterior bite planes.
Primary Outcome Measure Information:
Title
Change in the SNA angle
Description
This angle represents the position of upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and A.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Change in the SNB angle
Description
This anglrepresents the position of lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and B.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Change in the ANB angle
Description
This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between A, N, and B.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the MM angle
Description
This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the maxillary plane and mandibular plane.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the SN-OCP angle
Description
This angle represents the relationship between the occlusion plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the SN plane (anterior cranial base plane) and the OCP (occlusal) plane.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the SN-MP angle
Description
This angle represents the relationship between the lower jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the mandibular plane (MP plane).
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the SN-SPP angle
Description
This angle represents the relationship between the upper jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the maxillary plane (SPP plane).
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the overbite (Ovb)
Description
This is a vertical measurement done on the cephalometric tracings in millimeters. It is the vertical overlap between the upper incisors and the lower incisors.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the overjet (Ovj)
Description
This is a horizontal measurement done on the cephalometric tracings in millimeters. It is the amount of protrusion of upper incisors in relation to the lower incisors.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the Bjork sum
Description
Lateral cephalograms will be taken twice and this measurement is the sum of three different angles: (N-S-Ar + S-Ar-Go +Ar-Go-Me). These angles are well-known to orthodontists.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the N-A-Pog angle
Description
Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between three points: N, A, and Pogonion (Pog). N is located on the nasal bone. A is located at the maximum concavity of the anterior upper alveolus between the central incisors. Pog is the located at the most prominent point on the chin contour.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the UI- LI angle
Description
This angle represents the relationship between the upper and the lower incisor axes in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the long axis of the upper incisor and the long axis of the lower incisor.
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the NS-GN angle
Description
This angle represents the growth pattern of the mandible in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (NS plane) and the the Y-axis plane (i.e. the facial axis plane defined by two points: Sella Point and Gnathion 'Gn' Point).
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the posterior facial height (S-Go)
Description
This will be vertically measured in millimeters from S point to Go point. 'S' point referes to Sella Turcica point. 'Go' point refers to the gonial angle point (located at the corner of the mandibular ramus).
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the anterior facial height (N-Me)
Description
This will be vertically measured in millimeters from N point to Me point. 'N' point refers to the Nasion point. 'Me' point refers to the Menton point (located at the lower border of the chin).
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the 'NasoLab' angle
Description
This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the lower nasal tangent (i.e. the plane that touches the lower border of the columella), and the upper lip plane (i.e. the plane that goes through points Subnasale and Labrale Superius).
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Title
Changes in the 'MentoLab' angle
Description
This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between two planes: the lower lip tangent plane (from 'Labrale inferius' to mentolabial point) and upper anterior chin plane (from mentolabial point to Pogonion point).
Time Frame
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anterior open bite (2-10) mm. Skeletal Class I or II malocclusion. MP-SN angle ranged between (33-45) degrees. MM angle ranged between (27-37) degrees. Age between 7.5-10.5 years. Exclusion Criteria: Patients who had an old orthodontic treatment People with a syndrome or congenital deformity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahran Raheel Mousa, DDS MSc
Organizational Affiliation
PhD student, Orthodontics Department, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hassan Farah, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, University of Hama, Hama, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Orthodontic Department, University of Al-Baath Dental School
City
Hama
State/Province
Hamah
ZIP/Postal Code
12JO76WH
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17101701
Citation
Torres F, Almeida RR, de Almeida MR, Almeida-Pedrin RR, Pedrin F, Henriques JF. Anterior open bite treated with a palatal crib and high-pull chin cup therapy. A prospective randomized study. Eur J Orthod. 2006 Dec;28(6):610-7. doi: 10.1093/ejo/cjl053. Epub 2006 Nov 13.
Results Reference
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PubMed Identifier
18005832
Citation
Defraia E, Marinelli A, Baroni G, Franchi L, Baccetti T. Early orthodontic treatment of skeletal open-bite malocclusion with the open-bite bionator: a cephalometric study. Am J Orthod Dentofacial Orthop. 2007 Nov;132(5):595-8. doi: 10.1016/j.ajodo.2005.12.035.
Results Reference
background
PubMed Identifier
19915269
Citation
Meibodi SE, Fatahi Meybodi S, Samadi AH. The effect of posterior bite-plane on dentoskeletal changes in skeletal open-bite malocclusion. J Indian Soc Pedod Prev Dent. 2009 Oct-Dec;27(4):202-4. doi: 10.4103/0970-4388.57653.
Results Reference
background
PubMed Identifier
18068591
Citation
Cozza P, Baccetti T, Franchi L, Mucedero M. Comparison of 2 early treatment protocols for open-bite malocclusions. Am J Orthod Dentofacial Orthop. 2007 Dec;132(6):743-7. doi: 10.1016/j.ajodo.2005.11.045.
Results Reference
background
PubMed Identifier
27141934
Citation
Mucedero M, Vitale M, Franchi L, Cozza P, Perillo L. Comparisons of two protocols for early treatment of anterior open bite. Eur J Orthod. 2017 Jun 1;39(3):270-276. doi: 10.1093/ejo/cjw039.
Results Reference
background
PubMed Identifier
16769491
Citation
Cozza P, Baccetti T, Franchi L, McNamara JA Jr. Treatment effects of a modified quad-helix in patients with dentoskeletal open bites. Am J Orthod Dentofacial Orthop. 2006 Jun;129(6):734-9. doi: 10.1016/j.ajodo.2006.02.004.
Results Reference
background
PubMed Identifier
29911909
Citation
Rossato PH, Fernandes TMF, Urnau FDA, de Castro AC, Conti F, de Almeida RR, Oltramari-Navarro PVP. Dentoalveolar effects produced by different appliances on early treatment of anterior open bite: A randomized clinical trial. Angle Orthod. 2018 Nov;88(6):684-691. doi: 10.2319/101317-691.1. Epub 2018 Jun 18.
Results Reference
background
PubMed Identifier
18174075
Citation
Giuntini V, Franchi L, Baccetti T, Mucedero M, Cozza P. Dentoskeletal changes associated with fixed and removable appliances with a crib in open-bite patients in the mixed dentition. Am J Orthod Dentofacial Orthop. 2008 Jan;133(1):77-80. doi: 10.1016/j.ajodo.2007.07.012.
Results Reference
background
PubMed Identifier
34462242
Citation
Mousa MR, Hajeer MY, Farah H. Evaluation of the open-bite Bionator versus the removable posterior bite plane with a tongue crib in the early treatment of skeletal anterior open bite: A randomized controlled trial. J World Fed Orthod. 2021 Dec;10(4):163-171. doi: 10.1016/j.ejwf.2021.08.001. Epub 2021 Aug 27.
Results Reference
derived

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Early Treatment of Skeletal Anterior Open Bite by Two Appliances

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