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

NCT03481088 | Completed DMC

• 1 other identifier: Kavita
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Class II Division 2 Malocclusion

Outcome Measures

Primary Outcomes (7)

• 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

  16-18 months

• 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

  16-18 months

• 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.

  16-18 months

• 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

  16-18 months

• 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

  16-18 months

• 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.

  16-18 months

• 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.

  16-18 months

Study Arms (1)

Functional appliance therapy

OTHER

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)

Procedure: Functional appliance therapy

Interventions

Functional appliance therapy PROCEDURE

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)

Also known as: myofunctional therapy

Functional appliance therapy

Eligibility Criteria

• Age: 11 Years - 13 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Science

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• Kavita Negi, MDS student

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: March 29, 2018
• Study Start: January 9, 2017
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 8, 2021

Record last verified: 2018-03

Locations

IN (1)