CompletedNot Applicable

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

India15 participantsStarted 2017-01-09

Plain-language 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. 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

Who can participate

Age range

11 Years – 13 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Trial details

NCT IDNCT03481088

SponsorPostgraduate Institute of Dental Sciences Rohtak

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-30

View on ClinicalTrials.gov More Class II Division 2 Malocclusion trials

Plain-language summary

Who can participate

Age range

11 Years – 13 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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

Timeframe: 16-18 months

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