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Class II Division 2 MalocclusionNCT03481088

"Changes in TMJ by Twin Block Therapy in Skeletal Class II Div 2 Malocclusion in Adolescent Females : MRI Study"

A study testing Functional appliance therapy in people with Class II Division 2 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Completed

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

Official record
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Trial summary

It is a prospective descriptive study to evaluate TMJ disc-condyle-fossa relationship using MRI scan following functional appliance therapy in skeletal Class II Division 2 malocclusion in adolescent females. Read more about this study

Who is it for?
Ages 11 to 13 years, women onlyHealthy volunteers can take part
Conditions the study is for
Class II Division 2 Malocclusion
What is being tested?
Functional appliance therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteIndia
Study dates
9 Jan 2017to 30 Jun 2018
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 11 to 13 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patients in active growth period.
  • Skeletal Class II base with mandibular retrognathia.
  • Angle's Class II Division 2 malocclusion.
  • Low anterior facial height.
  • Patients having average to Horizontal growth pattern

Who cannot join

  • Patients with any internal derangement or pathology of TMJ.
  • History of previous orthodontic interventions or systemic diseases affecting bone metabolism.
  • Growth abnormality.
  • Patient with any endocrinal disorder
  • Bleeding disorders.
  • Patients with facial asymmetry

Trial locations and contacts

1 site in 1 country.

India1 site
  • Post Graduate Institute of Dental Science

    Rohtak, Haryana, 124001

Other trials in India

About this study

Official title: "Comparative Evaluation of the Temporomandibular Joint Disc-condyle-fossa Relationship Following Functional Appliance Therapy in Skeletal Class II Division 2 Malocclusion in Adolescent Females : A Magnetic Resonance Imaging Study"

It is a prospective descriptive study to evaluate TMJ disc-condyle-fossa relationship using MRI scan following functional appliance therapy in skeletal Class II Division 2 malocclusion in adolescent females.

All records, including MRI scans will be collected at three stages and will be traced for various angular and linear measurements to document the alterations within the condyle glenoid fossa complex

  1. Stage- I (pre-treatment),
  2. Stage- II (after pre-functional therapy)
  3. Stage-III (After 6-8 months of functional appliance therapy that is after correction to Class I molar relation
Read the detailed description

Angle's class II division 2 malocclusion is relatively rare. Its frequency lies between 1.5 and 5% of all occlusion in white western population while in north Indian population it is 5.8% Generally in Class II division 2 malocclusion mandibular denture is more distally placed in relation to maxillary denture, a compensating effect in this type of mandibular retrusion , which offsets some of the disharmony of the facial profile is that the chin point is usually very pronounced3. It has been stated that patients with skeletal class II division 2 malocclusion ,when compared with normal class I or class II division I subject have larger masticatory muscles that in addition are oriented in a more anterior direction. These characteristics results in significant differences regarding their mechanical advantage and magnitude of occlusal forces.5 Several investigators have also stated that the mandible is locked posteriorly in Angle's Class II division 2 malocclusion with deep bite and the treatment which unlocks the bite during an active growth period can allow the mandible to grow or be repositioned forward much more than if treatment of unlocking of a bite were not undertaken. In class II division 2 malocclusion the condyle is positioned posteriorly while the disk is positioned anteriorly in relation to glenoid fossa. The articular disc in Angle's class II Division 2 patients could take a relative protrusive position in comparison with the other Angle's classes of malocclusion .

Successful treatment of many orthodontic problems depends to a great extent on the amount of mandibular growth patients experience during treatment. Functional appliances have been used for nearly 100 years in an attempt to induce mandibular growth by changing muscle function and condyle glenoid fossa relationships. Several studies have shown that the treatment of skeletal Class II patients with functional appliances is more successful when initiated during the adolescent growth spurt.

MRI a multiplanar imaging technique, has the advantage of giving an accurate assessment of both the bony and the soft tissues.It has high sensitivity for visualization of position and configuration of disc . This technique is believed to be non-invasive, radiation free and gives more superior contrast resolution than any other imaging modality. Recent studies have shown that we can have greater confidence in MRI as diagnostic tool because of improved quality.

MATERIALS AND METHODS- It is a prospective descriptive study to evaluate TMJ disc-condyle-fossa relationship using MRI scan following functional appliance therapy in skeletal Class II Division 2 malocclusion in adolescent females.

The present study will be conducted in the Department of Orthodontics and Dentofacial Orthopedics, PGIDS, in association with the Department of Radiology, PGIMS, and Department of Oral Radiology, PGIDS, Pt B. D. Sharma University of Health Sciences, Rohtak.

. Ethical clearance approved by institutional Ethics Committee,Post Graduate Institute of Dental Sciences

Source of data:- The sample size consists of 15 subjects who were selected from the patients attending regular OPD at the Department of Orthodontics and Dentofacial Orthopedics for orthodontic treatment.

TARGET SAMPLE SIZE Sample size on= 13 for present study Calculation based on effect size of 1.23 with standard deviation of 10.5 at 95% confidence interval and 80% power n=2.{Z( 1-α/2)+Z(1-β)} 2/ ∆2 To compansate for 10 % dropout the final sample size will be 15

. INFORMED CONSENT OF THE PATIENT AND AGREEMENT TO BE RANDOMISED A valid, informed written consent of the patient or parent/ guardian and an agreement to be randomized was obtained from the patient before registering the patient in this clinical study. Patient or parent/ guardian was informed about all the theoretical risks and benefits of the intervention under test.

INTERVENTION AND DESIGN OF STUDY The study sample will consist of 15 growing females with skeletal class II and Angle's Class II division 2 malocclusion indicated for functional appliance therapy using Twin Block appliance.

The patients attending the regular OPD at the Department of Orthodontics and Dentofacial Orthopedics will be screened to match the inclusion criteria. Lateral Cephalograms will be taken to assess CVMI stage and growth pattern. Skeletal Class II Div 2 adolescent females with growth phase CVMI stage 2-4 having average to horizontal growth pattern as assessed by SN-MP (Go-Gn) angle will be included in the study.

Following detailed clinical examination, cephalometric analysis and treatment planning , the patients who will be ready to receive treatment will undergo pre-treatment MRI of condyle-glenoid fossa complex,then these patients will be treated with pre-functional therapy to correct retroclined incisors. After this, MRI of the TMJ of all these patients will be taken, that is after unlocking of mandible. Then these patients will undergo functional appliance therapy to achieve class 1 occlusion for an average of 6-8 months. After that, post fuctional MRI of the TMJ of all the patients will be taken.

The MRI protocol will include T1 weighted (T1W) spin echo sequences (TR 450/TE 15/Fov 160*160 mm), Proton density weighted spin echo sequences (TR 1500/TE 30/Fov 150*150) in coronal oblique and sagittal oblique planes of 3 mm slice thickness with no interslice gap. All records, including MRI scans will be collected at three stages and will be traced for various angular and linear measurements to document the alterations within the condyle glenoid fossa complex.

  1. Stage- I (pre-treatment),
  2. Stage- II (after pre-functional therapy)
  3. Stage-III (After 6-8 months of functional appliance therapy that is after correction to Class I molar relation ANGULAR AND LINEAR MEASUREMENTS The eminence angle and the sagittal disc position measured in relation to two reference lines: the posterior condylar line (PC line) and the Frankfurt Horizontal plane (FH Plane). The PC line to be drawn directly on the MRI scan, while the FH plane transferred from the lateral cephalogram to the MRI scan, according to the method given by Nebbe et al.

Transfer of FH plane Determination of long axis of the condyle will be done by two step circle center method by Nebbe et al.

ANGULAR MEASUREMENTS 1-2) The eminence angle and the coronal disc position will be evaluated by the method described by Chintakanon et al.

  1. The sagittal disc position will be evaluated using PC line and FH plane as described by Chintakanon et al.
  2. Sagittal condylar concentricity will be evaluated using the method described by Pullinger et al.
  3. The glenoid fossa angle will be measured on the sagittal films as the angle between the tangents to the anterior and posterior slopes of the glenoid fossa.

LINEAR MEASUREMENTS 6) Condyle and glenoid fossa displacements: The position of the glenoid fossa, and that of the condyle, will be evaluated with respect to the centre of the external auditory meatus (c-EAM). by marking one point at the centre of condyle (c-CH) and the linear distance of the c-CH from the c-EAM will be evaluated as the shortest distance from the constructed FH perpendicular.

  1. Distance between c-PGS (crest of the post-glenoid spine ) \& c-EAM : One point will be marked at the crest of the post-glenoid spine (c-PGS) and the linear distance of the c-PGS from the c-EAM will be evaluated as the shortest distance from the constructed FH perpendicular.
  2. Superior joint space will be measured from the shortest distance between the most superior point of the condyle and the most superior point of the mandibular fossa.

Statistical analysis:-The data recorded will be processed by standard statistical analysis

Being tested
Functional appliance therapy
Medical subject headings
Malocclusion, Angle Class II

What participants receive

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

  • Functional appliance therapyProcedure or surgery

    Also called myofunctional therapy

    All records, including MRI scans will be collected at three stages and will be traced for various angular and linear measurements to document the alterations within the condyle glenoid fossa complex.

    1. Stage- I (pre-treatment),
    2. Stage- II (after pre-functional therapy)
    3. Stage-III (After 6-8 months of functional appliance therapy that is after correction to Class I molar relation)
Study groups in NCT03481088
Study groupRoleWhat they receive
Functional appliance therapyOtherAll records, including MRI scans will be collected at three stages and will be traced for various angular and linear measurements to document the alterations within the condyle glenoid fossa complex. 1. Stage- I (pre-treatment), 2. Stage- II (after pre-functional therapy) 3. Stage-III (After 6-8 months of functional appliance therapy that is after correction to Class I molar relation)
Receives: Procedure: Functional appliance therapy

What is being measured

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

  1. MRI comparisons for TMJ condyle-disc and glenoid fossa changes like sagital concenticity in pretreatment prefunctional and postfunctional MRI.

    measured in percentage displacement of condyle in the glenoid fossa

    Measured: 16-18 months

  2. MRI comparisons for eminence angle in pretreatment prefunctional and postfunctional MRI.

    measured in degrees, the angle of anterior slope of glenoid fossa in relation to Frankfurt Horizontal plane and Posterior Condylar line

    Measured: 16-18 months

  3. MRI comparisons for sagittal disc position in pretreatment prefunctional and postfunctional MRI.

    measured in degrees from references from Frankfurt Horizontal plane and Posterior Condylar line.

    Measured: 16-18 months

  4. MRI comparisons for Linear glenoid fossa displacement in pretreatment prefunctional and postfunctional MRI.

    measured in millimetres, distance from external auditary meatus to centre of condylar head and Posterior glenoid spine

    Measured: 16-18 months

  5. MRI comparisons for glenoid fossa angle measured in degree in pretreatment prefunctional and postfunctional MRI.

    measured in degrees, angle between anterior slope and posterior slope of glenoid fossa

    Measured: 16-18 months

  6. MRI comparisons for coronal disc position in pretreatment prefunctional and postfunctional MRI.

    .relative position on the equal tenths on condyle. Negative value represents the lateral side; Positive value represents the medial side.

    Measured: 16-18 months

  7. MRI comparisons for Superior joint space in pretreatment prefunctional and postfunctional MRI.

    measured in millimetres, distance between most superior point on glenoid fossa and superiormost point on condyle.

    Measured: 16-18 months

Timeline

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

  1. First posted29 Mar 2018
  2. Study start9 Jan 2017
  3. Primary completion30 Apr 2018
  4. Study completion30 Jun 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03481088
Sponsor's protocol ID
Kavita
Status last verified
Mar 2018
First submitted
3 Mar 2018
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Aim of the study is to document the alterations within the condyle-glenoid fossa complex and the positional changes of the glenoid fossa in the cranium after active functional phase like sagittal concentricity, eminence angle, sagittal disc position,glenoid fossa angle and linear metric measurements To evaluate TMJ changes using MRI scan after pre-functional therapy, that is after unlocking of mandible. To compare the mandibular condyle disc-fossa relationship on Magnetic resonance imaging in adolescent female having Angle's Class II Division 2 malocclusion before and after twin block functional appliance therapy.

Questions about this trial

What is this clinical trial studying?

A study testing Functional appliance therapy in people with Class II Division 2 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

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 5 inclusion and 6 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 8 Feb 2021. 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 India. 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?

MRI comparisons for TMJ condyle-disc and glenoid fossa changes like sagital concenticity in pretreatment prefunctional and postfunctional MRI. (time frame: 16-18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Feb 2021.

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