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

NCT ID: NCT03645343

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-11-19

Brief Summary

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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

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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

Conditions

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Malocclusion, Angle Class II Retrognathism TMJ

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Activator

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

Group Type ACTIVE_COMPARATOR

Activator

Intervention Type DEVICE

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

Twin Block

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

Group Type EXPERIMENTAL

Twin Block

Intervention Type DEVICE

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Activator

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

Intervention Type DEVICE

Twin Block

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

Intervention Type DEVICE

Other Intervention Names

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Andresen Appliance Clark's appliance

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abdulmalek Majanni, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

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

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_CHAIR

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

Issam Khoury, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Locations

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Orthodontic Department, University of Damascus Dental School

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 20578854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25564505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11244427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25329768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26434757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3422118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27152081 (View on PubMed)

Other Identifiers

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UDDS-Ortho-09-2018

Identifier Type: -

Identifier Source: org_study_id

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