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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04849442
Other study ID # msalah_bfpt
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date September 30, 2019

Study information

Verified date April 2021
Source Horus University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since TMJ and cervical pain incidence are rising and both structures are highly interrelated anatomically and functionally. And yet no standard protocol for TMD therapy The objective of this study is to state if there is a correlation between TMD and cervical dysfunction. To help reach a better diagnosis and a more holistic treatment. Forty volunteers (15 male and 25 female) between the ages of 20 to 40 were recruited. Cervical ROM was measured in all directions (rotation, flexion and extension, and sidebending) by CROM device, and a 10 cm plastic ruler marked in both centimeters and millimeters was used to measure TMJ vertical opening.


Description:

Background: The incidence of temporomandibular dysfunction has been rapidly increasing in the past years especially among women and still no definite treatment protocol and that's due to the inter lapping of anatomy and neurology of this joint with other structures all over the body. The cervical spine dysfunction has a high incidence as well, and they are common to coexist as they are highly interrelated. Objective: The objective of this study is to emphasize the interrelation between cervical dysfunction and TMJ dysfunction by examining the relationship between cervical spine ROM and TMJ vertical opening ROM to provide better recognition of the etiology of TMJ dysfunction thus a holistic intervention. Materials and methods: It is a bivariate correlational research design. Forty subjects between the age of 20 -40 years (15male/ 25females) were recruited. Cervical ROM was measured by CROM device for all 6 cervical movements. The TMJ vertical mouth opening was measured by a 10 cm ruler. The CROM will be used consistent with standard clinical procedures, with 3 takes for each measurement to decrease human error. The measurements were taken one shot.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: 1. Between the ages of 20 and 40 2. Female and Male 3. Suffering from a reduced cervical ROM 4. No reported TMJ pain Exclusion Criteria: - 1) Tumor (anywhere in the body) 5. Recent trauma to the neck, torso or upper limb 6. Active inflammation in the cervical region, upper thoraxic spine and chest or upper limb 7. Recent use of orthodontics prostheses

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Outpatient clinic, Faculty of Physical Therapy, Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cervical spine range of motion by CROM measuring the change of cervical range of motion in all directions (rotation, flexion and extension, and side bending) "through study completion, an average of 3 months"
Secondary TMJ vertical opening measuring the change of TMJ vertical opening by the second device used was a 10 cm plastic ruler marked in both centimeters and millimeters was used in the measurements, with (ICC 2,K) varied from 0.90 to 1.0, placed between the upper and lower edges of the central incisors "through study completion, an average of 3 months"
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