Malocclusion, Angle Class IINCT03645343

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

A study testing Activator and Twin Block in people with Malocclusion, Angle Class II and Retrognathism, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 10 to 13 years
Conditions the study is for: Malocclusion, Angle Class II, Retrognathism, TMJ
What is being tested?: Activator and Twin Block
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteSyria
Study dates: 15 Jun 2018to 19 Nov 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 13 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

Orthodontic Department, University of Damascus Dental School
Damascus, DM20AM18

Other trials in Syria

About this study

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

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

Read the 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

Conditions: Malocclusion, Angle Class II, Retrognathism, TMJ
Being tested: Activator, Twin Block
Medical subject headings: Malocclusion, Angle Class II, Retrognathia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ActivatorDevice
Also called Andresen Appliance
This appliance is constructed in one piece to guide the position of the mandible on closure
Twin BlockDevice
Also called Clark's appliance
This appliance is constructed in two pieces to guide the position of the mandible on closure

Study groups in NCT03645343
Study group	Role	What they receive
Activator	Active comparator	Patients will be treated using the Activator appliance for one and a half year Receives: Device: Activator
Twin Block	Experimental	Patients will be treated using the Twin Block appliance for 18 months on average Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)).
Measured: 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))
Measured: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201819 Nov 2019

First posted24 Aug 2018
Study start15 Jun 2018
Primary completion19 Mar 2019
Study completion19 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Malocclusion, Angle Class IIStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03645343
Sponsor's protocol ID: UDDS-Ortho-09-2018
Status last verified: Jan 2020
First submitted: 22 Aug 2018
Last updated: 5 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 20578854
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.
PubMed 25564505
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.
PubMed 11244427
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.
PubMed 25329768
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.
PubMed 26434757
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.
PubMed 3422118
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.
PubMed 27152081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II

All Malocclusion, Angle Class II trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03645343
Acronym / sponsor ID: UDDS-Ortho-09-2018
Conditions: Malocclusion, Angle Class II, Retrognathism, TMJ
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Jun 2018 (actual)
Primary completion: 19 Mar 2019 (actual)
Study completion: 19 Nov 2019 (actual)
First posted: 24 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Activator	Active comparator	Device: ActivatorPatients will be treated using the Activator appliance for one and a half year
Twin Block	Experimental	Device: Twin BlockPatients will be treated using the Twin Block appliance for 18 months on average
Control	No intervention	–Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group

Who may qualify

Ages: 10 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ActivatorAlso: Andresen ApplianceThis appliance is constructed in one piece to guide the position of the mandible on closure	Device	Activator
Twin BlockAlso: Clark's applianceThis appliance is constructed in two pieces to guide the position of the mandible on closure	Device	Twin Block

Primary outcome

Change in Glenoid Fossa Height
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Border mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)).
Change in the Discrepancy between CO and CR
Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment
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))

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Background: PubMed 20578854Aidar 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.
Background: PubMed 25564505Cacho 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.
Background: PubMed 11244427Arat 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.
Background: PubMed 25329768Chavan 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.
Background: PubMed 26434757Cimic 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.
Background: PubMed 3422118Clark 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.
Background: PubMed 27152081Costea 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.
Individual participant dataSharing planned: No

Related trials for Malocclusion, Angle Class II

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abdulmalek Majanni, DDS MSc principal investigator

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

Mohammad Y Hajeer, DDS MSc PhD study chair

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

Issam Khoury, DDS MSc PhD study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Activator and Twin Block in people with Malocclusion, Angle Class II and Retrognathism, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glenoid Fossa Height (time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645343, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.