NCT04744337

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 females initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 Malocclusion.

Trial Health

87
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 Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

September 15, 2018

Last Update Submit

February 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • MRI comparisons for TMJ adaptations in adolescent females

    TMJ adaptations with the help of various angular and linear measurements in adolescent females before and after fixed orthodontic therapy who were initially treated with functional appliance therapy.

    12 months

Study Arms (1)

orthodontic treatment

OTHER

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

Procedure: orthodontic treatment

Interventions

fixed orthodontic treatment in adolescent females 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 - 15 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
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. 2.History of systemic diseases affecting bone metabolism. 3.Growth abnormality. 4.Bleeding disorders. 5. Patients with facial asymmetry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Preeti Nain, 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2018

First Posted

February 8, 2021

Study Start

December 1, 2017

Primary Completion

January 1, 2019

Study Completion

April 1, 2019

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

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 females initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion.

Locations