Prevalence of the Signs and Symptoms of TMD in Adolescents | NCT04543981

Studies
Prevalence of the Signs and Symptoms of TMD in Adolescents

NCT04543981

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 10, 2020Actual

Enrollment

733Estimated

Phase

Not provided

Conditions

TMJ Disorder
TMD

Interventions

Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Sep 3, 2020

First Submission Date that Met QC Criteria

Sep 3, 2020

First Posted Date

Sep 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2020

Last Update Posted Date

Sep 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the Prevalence of the Signs and Symptoms of Tempro-mandibular Joint Disorder in a sample of Egyptian adolescents

Detailed Description

Our study is observational cross sectional study to evaluate the prevalence ofTempro-mandibular Joint Disorder( TMDs) in Egyptian adolescents based on Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD) .The following examinationwill be done for each patient and recorded in his/her chart:

Include maximal mandibular opening capacity, joint noises, deviation of mandible during opening and closing, tenderness of the TMJ and masticatory muscles, headache and pain in TMJ area.

All clinical examinations will be carried out by one investigator. Examination of TMJ disorders include the following aspects: I) Examination of TMJ sounds (clicking and crepitus) using a stethoscope over the TMJ area and by having the patient open and close the mouth.

II) Associated muscle disorders will be determined by:

palpation of TMJ area.
digital palpation and functional manipulation of the masticatory muscles according to Okeson.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

733Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD)	Diagnostic Test	diagnostic sheet include questions to be answered by the patients and others include examinations will be done by the investigator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TMD	adolescents diagnosed positively for any TMD subtype (overall TMD) by DC/TMD.	at the time of examination of each participant

Secondary Outcomes

Measure	Description	Time Frame
Myofacial pain	pain in each muscle of mastication will be recorded	at the time of examination of each participant
mouth opening	limitation of mouth opening and pain during such movement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adolescents(age range10-18 years old).
A well-defined dentalCl I, Cl II/1, Cl II/2, and Cl III relationship (Angle Classification).
Mixed and permanent dentition.
Both sexes.
Normal skeletal pattern

Exclusion Criteria:

Adolescents with syndromes.
Systemic diseases affecting bones.
Adolescents with rheumatoid arthritis.
Previous trauma in the face.
Neurological disorders.
Psychiatric disorders.
Neoplasia.
Adolescents who had received orthodontic treatment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

DC/TMD shhts will be assessed and obtained from adolescents in Diagnostic center clinic at the faculty of Dentistry, Cairo University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Abdelaleem	Contact	01005246200	+2	mohamed.abdelaleem@dentistry.cu.edu.eg
Aya Abdelaleem, BDS	Contact	01012284977	+2	ayaabdulrhman1993@gmail.com

Overall Officials

Name	Affiliation	Role
Manal foda, professor	Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University	Recruiting	Cairo	Cairo/Giza	12511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013705	Temporomandibular Joint Disorders

Ancestor Terms

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided