The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements
Primary Purpose
Malocclusion, Angle Class II, Retrognathism, TMJ
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Activator
Twin Block
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion, Angle Class II
Eligibility Criteria
Inclusion Criteria:
Class II malocclusion Skeletal class II with retruded mandibles. Old between 10-13 years Healthy TMJ Horizontal or normal growth pattern
Exclusion Criteria:
Patients who have been treated previously Patients with syndromes or congenital deformities Signs or symptoms of temporomandibular disorders.
Sites / Locations
- Orthodontic Department, University of Damascus Dental School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Activator
Twin Block
Control
Arm Description
Patients will be treated using the Activator appliance for one and a half year
Patients will be treated using the Twin Block appliance for 18 months on average
Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group
Outcomes
Primary Outcome Measures
Change in Glenoid Fossa Height
Glenoid fossa height: the vertical space between the roof and lowest edge of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in Glenoid Fossa Width
Glenoid fossa width: the horizontal space between the anterior and posterior wall of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in Articular Eminence Inclination
Articular Eminence inclination: the angle between a horizontal plane and the posterior slope of the articular eminence. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in Condylar Height
Condylar Height: the vertical height of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in Condylar Width
Condylar Width: the horizontal width of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in Condylar Length
Condylar Length: the mesio-distal length of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in Condylar Circumference
Condyle circumference: the outer circumference of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in the Anterior Joint Space
Anterior Joint Space: the space between the anterior edge of condyle and the posterior slope of the articular eminence.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in the Superior Joint Space
Superior Joint Space: the space between the superior edge of the condyle and the roof of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in the Posterior Joint Space
Posterior joint space: the space between the posterior edge of the condyle and the posterior board of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Change in Border Mandibular Movements
Border mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)).
Change in the Discrepancy between CO and CR
CO-CR discrepancy: we will measure distance between centric relation and centric occlusion in three dimensions (sagittal, coronal and axial ). These measurements will be done by an electronic axiograph (Arcosdigma(R))
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03645343
Brief Title
The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements
Official Title
The Effect of Functional Treatment Using the Activator Versus the Twin Block on the Temporomandibular Joint and the Mandibular Movements in Skeletal Class II Patients: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
November 19, 2019 (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
Patients with class II malocclusion and retrognathic mandibles will be treated using functional appliances and asses the remodeling that is expected to occur in the temporomandibular joint (TMJ) using cone-beam computed tomography (CBCT) images and we will register mandibular movements using electronic axiograph ( a specific apparatus used to record jaw movements in three dimensions).
There are three groups :
Activator Group
Twin block Group
Control Group with no treatment.
Patients will be allocated to the three groups randomly.
Data will be collected using three different approaches:
CBCT images before treatment and 12 months after treatment
Axiograph registrations before treatment and 12 months after treatment
Detailed Description
The main purposes of this project are:
to evaluate the remodeling effects that would take place in the bone structures of the temporomandibular joint (TMJ) during functional treatment.
to evaluate the possible change that may occur in mandibular movements following functional treatment.
to evaluate the possible change in the spatial relationship between centric occlusion (CO) and centric relation (CR) following functional treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II, Retrognathism, TMJ
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activator
Arm Type
Active Comparator
Arm Description
Patients will be treated using the Activator appliance for one and a half year
Arm Title
Twin Block
Arm Type
Experimental
Arm Description
Patients will be treated using the Twin Block appliance for 18 months on average
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group
Intervention Type
Device
Intervention Name(s)
Activator
Other Intervention Name(s)
Andresen Appliance
Intervention Description
This appliance is constructed in one piece to guide the position of the mandible on closure
Intervention Type
Device
Intervention Name(s)
Twin Block
Other Intervention Name(s)
Clark's appliance
Intervention Description
This appliance is constructed in two pieces to guide the position of the mandible on closure
Primary Outcome Measure Information:
Title
Change in Glenoid Fossa Height
Description
Glenoid fossa height: the vertical space between the roof and lowest edge of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in Glenoid Fossa Width
Description
Glenoid fossa width: the horizontal space between the anterior and posterior wall of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in Articular Eminence Inclination
Description
Articular Eminence inclination: the angle between a horizontal plane and the posterior slope of the articular eminence. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in Condylar Height
Description
Condylar Height: the vertical height of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in Condylar Width
Description
Condylar Width: the horizontal width of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in Condylar Length
Description
Condylar Length: the mesio-distal length of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in Condylar Circumference
Description
Condyle circumference: the outer circumference of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in the Anterior Joint Space
Description
Anterior Joint Space: the space between the anterior edge of condyle and the posterior slope of the articular eminence.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in the Superior Joint Space
Description
Superior Joint Space: the space between the superior edge of the condyle and the roof of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in the Posterior Joint Space
Description
Posterior joint space: the space between the posterior edge of the condyle and the posterior board of the fossa.
This measurement will be done on the 3D software (3D OnDemand) using CBCT images
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in Border Mandibular Movements
Description
Border mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)).
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Title
Change in the Discrepancy between CO and CR
Description
CO-CR discrepancy: we will measure distance between centric relation and centric occlusion in three dimensions (sagittal, coronal and axial ). These measurements will be done by an electronic axiograph (Arcosdigma(R))
Time Frame
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Class II malocclusion Skeletal class II with retruded mandibles. Old between 10-13 years Healthy TMJ Horizontal or normal growth pattern
Exclusion Criteria:
Patients who have been treated previously Patients with syndromes or congenital deformities Signs or symptoms of temporomandibular disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdulmalek Majanni, DDS MSc
Organizational Affiliation
PhD Student in Orthodontics, University of Damascus Dental School, Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Issam Khoury, DDS MSc PhD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, SYRIA
Official's Role
Study Director
Facility Information:
Facility Name
Orthodontic Department, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20578854
Citation
Aidar LA, Dominguez GC, Yamashita HK, Abrahao M. Changes in temporomandibular joint disc position and form following Herbst and fixed orthodontic treatment. Angle Orthod. 2010 Sep;80(5):843-52. doi: 10.2319/093009-545.1.
Results Reference
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PubMed Identifier
25564505
Citation
Cacho A, Ono T, Kuboki T, Martin C. Changes in joint space dimension after the correction of Class II division 1 malocclusion. Eur J Orthod. 2015 Oct;37(5):467-73. doi: 10.1093/ejo/cju091. Epub 2015 Jan 6.
Results Reference
background
PubMed Identifier
11244427
Citation
Arat ZM, Gokalp H, Erdem D, Erden I. Changes in the TMJ disc-condyle-fossa relationship following functional treatment of skeletal Class II Division 1 malocclusion: a magnetic resonance imaging study. Am J Orthod Dentofacial Orthop. 2001 Mar;119(3):316-9. doi: 10.1067/mod.2001.110245.
Results Reference
background
PubMed Identifier
25329768
Citation
Chavan SJ, Bhad WA, Doshi UH. Comparison of temporomandibular joint changes in Twin Block and Bionator appliance therapy: a magnetic resonance imaging study. Prog Orthod. 2014 Oct 1;15(1):57. doi: 10.1186/s40510-014-0057-6.
Results Reference
background
PubMed Identifier
26434757
Citation
Cimic S, Badel T, Simunkovic SK, Pavicin IS, Catic A. Centric slide in different Angle's classes of occlusion. Ann Anat. 2016 Jan;203:47-51. doi: 10.1016/j.aanat.2015.09.001. Epub 2015 Sep 30.
Results Reference
background
PubMed Identifier
3422118
Citation
Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.
Results Reference
background
PubMed Identifier
27152081
Citation
Costea CM, Badea ME, Vasilache S, Mesaros M. Effects of CO-CR discrepancy in daily orthodontic treatment planning. Clujul Med. 2016;89(2):279-86. doi: 10.15386/cjmed-538. Epub 2016 Apr 15.
Results Reference
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The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements
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