Clinical trial NCT03645343: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II
Retrognathism
TMJ
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 66
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 :

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

Detailed 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

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.

Primary outcomes:
measure: Change in Glenoid Fossa Height
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in Glenoid Fossa Width
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in Articular Eminence Inclination
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in Condylar Height
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in Condylar Width
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in Condylar Length
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in Condylar Circumference
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in the Anterior Joint Space
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in the Superior Joint Space
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in the Posterior Joint Space
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in Border Mandibular Movements
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
measure: Change in the Discrepancy between CO and CR
timeFrame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Orthodontic Department, University of Damascus Dental School
Study officials:
affiliation: PhD Student in Orthodontics, University of Damascus Dental School, Damascus
name: Abdulmalek Majanni, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_CHAIR
affiliation: Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, SYRIA
name: Issam Khoury, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.