Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03645343
Other study ID # UDDS-Ortho-09-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2018
Est. completion date November 19, 2019

Study information

Verified date January 2020
Source Damascus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 :

1. Activator Group

2. Twin block Group

3. 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


Description:

The main purposes of this project are:

1. to evaluate the remodeling effects that would take place in the bone structures of the temporomandibular joint (TMJ) during functional treatment.

2. to evaluate the possible change that may occur in mandibular movements following functional treatment.

3. to evaluate the possible change in the spatial relationship between centric occlusion (CO) and centric relation (CR) following functional treatment


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date November 19, 2019
Est. primary completion date March 19, 2019
Accepts healthy volunteers No
Gender All
Age group 10 Years to 13 Years
Eligibility 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.

Study Design


Intervention

Device:
Activator
This appliance is constructed in one piece to guide the position of the mandible on closure
Twin Block
This appliance is constructed in two pieces to guide the position of the mandible on closure

Locations

Country Name City State
Syrian Arab Republic Orthodontic Department, University of Damascus Dental School Damascus

Sponsors (1)

Lead Sponsor Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

Aidar LA, Dominguez GC, Yamashita HK, Abrahão 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. — View Citation

Arat ZM, Gökalp 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. — View 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. — View 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;15:57. doi: 10.1186/s40510-014-0057-6. — View Citation

Cimic S, Badel T, Šimunkovic 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. — View Citation

Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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 T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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 T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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 T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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 T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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 T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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
T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary Change in Border Mandibular Movements Border mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)). T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary 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)) T1: at one day before the commencement of treatment; T2: after 12 months of treatment
See also
  Status Clinical Trial Phase
Recruiting NCT06297109 - Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery N/A
Recruiting NCT05227469 - Myofunctional Therapy Twin Block N/A
Completed NCT05356780 - Predictability of Orthodontic Tooth Movement With Invisalign Aligners
Not yet recruiting NCT05467579 - Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects N/A
Completed NCT01530516 - Crossbow Versus Forsus Springs in Mild to Moderate Class II Malocclusion Cases N/A
Recruiting NCT04875104 - Upper Sequential Distalization With TADs and Aligners N/A
Not yet recruiting NCT05853211 - Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skelettal Patterns
Completed NCT04175405 - Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability. N/A
Completed NCT02456220 - Dentoskeletal Changes Associated With Herbst Appliance Therapy N/A
Recruiting NCT05950581 - Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates N/A
Completed NCT04276402 - Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants. N/A
Completed NCT03239912 - Treatment of Class II Malocclusion Combined With Low-level Laser N/A
Recruiting NCT03773783 - Study to Compare Two Functional Appliances for Class II Malocclusions N/A
Recruiting NCT05499221 - Bone Anchored Carriere Motion Appliance N/A
Completed NCT03159962 - Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects N/A
Active, not recruiting NCT02010346 - The Effect of Timing on Orthodontic Treatment N/A
Completed NCT06240923 - "Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches" N/A
Completed NCT05298280 - Vertical Effects in Class II Patients Treated With Distalization N/A
Completed NCT04556448 - RCT Comparing Invisalign and Traditional Orthodontic Treatment N/A
Completed NCT03455634 - Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success N/A