The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements

NCT03645343 | Completed DMC

• 1 other identifier: UDDS-Ortho-09-2018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 :

• CBCT images before treatment and 12 months after treatment
• Axiograph registrations before treatment and 12 months after treatment

Conditions

Malocclusion, Angle Class II; Retrognathism; TMJ

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Activator

ACTIVE COMPARATOR

Patients will be treated using the Activator appliance for one and a half year

Device: Activator

Twin Block

EXPERIMENTAL

Patients will be treated using the Twin Block appliance for 18 months on average

Device: Twin Block

Control

NO INTERVENTION

Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group

Interventions

Activator DEVICE

This appliance is constructed in one piece to guide the position of the mandible on closure

Also known as: Andresen Appliance

Activator

Twin Block DEVICE

This appliance is constructed in two pieces to guide the position of the mandible on closure

Also known as: Clark's appliance

Twin Block

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Class II malocclusion Skeletal class II with retruded mandibles. Old between 10-13 years Healthy TMJ Horizontal or normal growth pattern

You may not qualify if:

• Patients who have been treated previously Patients with syndromes or congenital deformities Signs or symptoms of temporomandibular disorders.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontic Department, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (7)

• 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.

  PMID: 20578854 BACKGROUND

• 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.

  PMID: 25564505 BACKGROUND

• 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.

  PMID: 11244427 BACKGROUND

• 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.

  PMID: 25329768 BACKGROUND

• 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.

  PMID: 26434757 BACKGROUND

• 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.

  PMID: 3422118 BACKGROUND

• 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.

  PMID: 27152081 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II; Retrognathia

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Officials

• Abdulmalek Majanni, DDS MSc

  PhD Student in Orthodontics, University of Damascus Dental School, Damascus

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY CHAIR

• Issam Khoury, DDS MSc PhD

  Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, SYRIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: June 15, 2018
• Primary Completion: March 19, 2019
• Study Completion: November 19, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)