NCT03406559

Brief 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 appliances for skeletal class II, Angle's class II division 2 malocclusion

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

January 15, 2018

Last Update Submit

March 20, 2018

Conditions

Outcome Measures

Primary Outcomes (7)

  • sagittal condyle concentricity

    measured in percentage displacement of condyle in the glenoid fossa

    12 months

  • sagittal disc position

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

    12 months

  • Linear glenoid fossa displacement

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

    12 months

  • Superior joint space

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

    12 months

  • eminence angle

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

    12 months

  • Glenoid fossa angle

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

    12 months

  • 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

    12 months

Study Arms (1)

orthodontic treatment

OTHER

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

Other: orthodontic treatment

Interventions

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

Also known as: fixed mechanotherapy
orthodontic treatment

Eligibility Criteria

Age13 Years - 16 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

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.
  • Bleeding disorders.
  • Patients with facial asymmetry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • deepak sindhu, mds student

    PGIDS Rohtak, Haryana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: study on 14 male adolescent patients having skeletal class II, Angle's class II division 2 malocclusion.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

October 29, 2016

Primary Completion

January 10, 2017

Study Completion

October 17, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03