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Class II Division 2 MalocclusionNCT03406559

TMJ Adaptations by Orthodontic Treatment in Adolescent Males With Angle's Class II Division 2 Malocclusion: MRI Study

A study testing orthodontic treatment in people with Class II Division 2 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak.

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

the aim of this study is to document the changes brought about in the internal anatomic relationships of the TMJ complex , positional changes of glenoid fossa with respect to adjacent cranial structures after completion of fixed orthodontic treatment in adolescent males initially treated with removable functional… Read more about this study

Who is it for?
Ages 13 to 16 years, men onlyHealthy volunteers can take part
Conditions the study is for
Class II Division 2 Malocclusion
What is being tested?
orthodontic treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
29 Oct 2016to 17 Oct 2017
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 13 to 16 years
  • Men only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • • Cases with moderate skeletal Class II bases with mandibular retrognathia, Angle's Class II division 2 malocclusion treated initially with prefunctional and functional appliance therapy in their active growth period and will be ready for fixed orthodontic treatment and have had MRI done at following stages:
  • Stage- A (pre-treatment)
  • Stage- B (after pre-functional therapy)
  • Stage-C (After completion of functional appliance therapy)

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.
  • Bleeding disorders.
  • Patients with facial asymmetry.

About this study

Official title: Comparison of TMJ Disc-condyle-fossa Relationship, After Fixed Orthodontic Treatment of Adolescent Males With Skeletal Class II, Angle's Class II Division 2 Malocclusion Treated Initially With Removable Functional Appliance: an MRI Study.

the aim of this study is to document the changes brought about in the internal anatomic relationships of the TMJ complex , positional changes of glenoid fossa with respect to adjacent cranial structures after completion of fixed orthodontic treatment in adolescent males initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion

Read the detailed description

Angle's class II division 2 malocclusion is subtype of Angle's class II malocclusion with unique facial, dental and craniofacial features which differentiate it from other malocclusions so much that it has been said to be a syndrome itself. Its frequency lies between 1.5 and 5% of all malocclusions found in a white western population.. Condyle position changes from anterior to posterior with age in class II division 2 cases. The use of functional orthopedic appliances to correct Class II malocclusions associated with retrognathic mandibles is indicated for the first phase of orthodontic treatment. A second phase of treatment is undertaken with fixed orthodontic appliances to obtain occlusal refinement. Although various investigations have shown the efficiency of this method of treatment, the mechanism by which the temporomandibular joint (TMJ) responds to the treatment is controversial.

Various techniques have been used to image the TMJ which include Magnetic Resonance Imaging (MRI), Cephalograms, Orthopantomograms , Tomograms , Bone scintigraphy with radiologic markers like 99mTc-MDP, Arthroscopy and Arthrography , CT scanning, Cone Beam Computed Tomography (CBCT).

Magnetic Resonance Imaging (MRI), a multiplanar imaging technique, has the advantage of giving an accurate assessment of both the bony and the soft tissues. This technique is believed to be non-invasive, radiation free and gives more superior contrast resolution than any other imaging modality. MRI is considered the imaging modality of choice for assessment of internal derangements of the temporomandibular joint. Bony structures and especially soft tissues of the TMJ can be examined by means of MRI and the relations of the tissues with each other can be evaluated.

MRI studies have been done on fixed functional appliances which show significant displacement of condyle during treatment but later condyles returned to pre treatment positions at the end of fixed functional appliance treatment. Results documented in fixed functional appliance may not be same in removable appliances. Effects of removable functional appliances on the condyle-glenoid fossa (C-GF) complex have been studied with respect to the Frankel, Activator, Twin block and Bionator appliances.It should be noted that all of above studies are limited to the phase of removable functional appliance therapy only in Class II division 1 and no MRI study has attempted to evaluate the changes in the position of the Condyle-Glenoid Fossa (C-GF) complex treated with removable functional appliance therapy, followed by fixed orthodontic treatment in Class II division 2 malocclusion.

No studies have been done on bi-phasic treatment of skeletal class II, Angle's class II division 2 involving removable functional appliances in the first phase followed by fixed orthodontic treatment in second phase.

Therefore, the aim of this study is to document the changes brought about in the internal anatomic relationships of the TMJ complex , positional changes of glenoid fossa with respect to adjacent cranial structures after completion of fixed orthodontic treatment in adolescent males initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion,

MATERIALS AND METHODS

It is a longitudinal clinical trial to evaluate TMJ disc-condyle-fossa relationship using MRI scan following bi-phasic therapy in skeletal Class II, Angle's class II division 2 malocclusion in adolescent males.

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- The study will be carried out in humans after the institutional approval obtained from ethical committee.

Source of Data The study sample will consist of the subjects from the Department of Orthodontics and Dentofacial Orthopedics, PGIDS , who will be successfully completing the prefunctional and functional appliance therapy for correction of skeletal class II, Angle's class II division 2 malocclusion and will be ready for fixed orthodontic treatment for final finishing and detailing of occlusion

INFORMED CONSENT OF THE PATIENT

A valid, bilingual informed written consent of the patient or parent/guardian will be obtained from the patient before registering the patient in this clinical study. Patients will be informed of all the theoretical risks and benefits of the interventions under test.

Intervention and design of study The study sample will consist of those 14 adolescent males who had been treated initially with pre functional and functional appliance therapy for skeletal Class II, Angle's class II division 2 malocclusion and had following MRI scans done during the treatment

  1. Stage- A (pre-treatment),
  2. Stage- B (after pre-functional therapy)
  3. Stage- C (After completion of Functional Appliance Therapy) These patients will be further treated with fixed orthodontic treatment for final finishing and detailing and an MRI will be taken after debonding of fixed orthodontic appliance (stage D). MRI scans thus obtained will be evaluated for documenting changes in the morphology and anatomic positions of condylar head, articular disc and glenoid fossa and will be traced for the various angular and linear metric measurements MRI scans of the TMJ will be obtained with a 1.5 Tesla Philips Intera Nova Gradient (Netherlands) scanner equipped with Sense Head 6 channel coil for simultaneous imaging of right and left joints. Sagittal images will be taken perpendicular to the long axis of the condylar head and the coronal images will be taken parallel to the long axis of the condylar head. The images will be recorded in maximum intercuspation after debonding of fixed orthodontic appliance. The MRI protocol will include PD TSE (Turbo Spin Echo) sequence (TR 1500/ TE 30/ FoV 150x150 mm) T1 spin echo sequences (TR 450⁄TE 15⁄FoV 160x160 mm) and T2 TSE sequence (TR 2424⁄ TE 100⁄FoV 160x160 mm).

FIXED MECHANOTHERAPY TREATMENT PHASE

The sample will be having cases in class I/ superclass I molar relation and lateral open bite may be present in premolar regions after the completion of functional phase. The final fixed orthodontic phase will be taken up for the final finishing and detailing of the occlusion after the retentive phase of functional appliance therapy is completed. It involves banding and bonding of both upper and lower arches with MBT 0.022" appliance. Progressive wire sequences to be used are 0.014" NiTi, 0.016" NiTi, 0.018" NiTi, 0.017" x 0.025" NiTi, 0.019"x 0.025" NiTi, , 0.019"x 0.025" S.S., 0.014" S.S. Once stainless steel archwires are in place, class II elastics may be prescribed to the patient to prevent relapse of class I molar relation achieved. Cases are to be finished in class I molar intercuspation with normal overjet and overbite. Appliance will be debonded and final MRI (stage D) will taken for all the patients. Hawley's retainer with anterior bite plane will serve for retention of achieved results

Evaluation of MRI stages This will be done with the help of various angular and linear measurements like the eminence angle, 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 coronal disc position , Sagittal condylar concentricity 5) The glenoid fossa angle, Condyle and glenoid fossa displacements and Superior joint space

Statistical analysis The final data recorded will be processed by standard statistical analysis.

Being tested
orthodontic treatment
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.

  • orthodontic treatmentOther

    Also called fixed mechanotherapy

    fixed orthodontic treatment in adolescent males initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion,

Study groups in NCT03406559
Study groupRoleWhat they receive
orthodontic treatmentOtherfixed orthodontic treatment in adolescent males initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion.
Receives: Other: orthodontic treatment

What is being measured

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

  1. sagittal condyle concentricity

    measured in percentage displacement of condyle in the glenoid fossa

    Measured: 12 months

  2. sagittal disc position

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

    Measured: 12 months

  3. Linear glenoid fossa displacement

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

    Measured: 12 months

  4. Superior joint space

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

    Measured: 12 months

  5. eminence angle

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

    Measured: 12 months

  6. Glenoid fossa angle

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

    Measured: 12 months

  7. coronal disc position

    relative position on the equal tenths on condyle. negative value representing lateral side and positive value indicating the medial side of the disc

    Measured: 12 months

Timeline

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

  1. First posted23 Jan 2018
  2. Study start29 Oct 2016
  3. Primary completion10 Jan 2017
  4. Study completion17 Oct 2017

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
Model description
study on 14 male adolescent patients having skeletal class II, Angle's class II division 2 malocclusion.
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406559
Sponsor's protocol ID
deepak sindhu
Status last verified
Mar 2018
First submitted
15 Jan 2018
Last updated
22 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: the aim of this study is to document the changes brought about in the internal anatomic relationships of the TMJ complex , positional changes of glenoid fossa with respect to adjacent cranial structures after completion of fixed orthodontic treatment in adolescent males initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion

Questions about this trial

What is this clinical trial studying?

A study testing orthodontic treatment in people with Class II Division 2 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak.

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 4 inclusion and 5 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

sagittal condyle concentricity (time frame: 12 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 22 Mar 2018.

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