Neck Pain Clinical Trial
Official title:
Prevalence of Temporomandibular Disorders and Its Association With Oral Parafunctions, Neck Pain and Function in Female Turkish Healthcare Students: A Cross-Sectional Study
NCT number | NCT04495777 |
Other study ID # | tmd_101 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | June 1, 2020 |
Verified date | August 2022 |
Source | Aydin Adnan Menderes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Purpose: To determine the prevalence of temporomandibular disorders (TMD) in female healthcare students and to assess its association with oral parafunctions, neck pain and function. Methods: Female medical students will be included in the study on a voluntary basis using stratified sampling method according to the department they were being educated. The presence and severity of TMD will be assessed with the Fonseca's Anamnestic Index (FAI). The oral parafunctions will be self-reported with the Oral Behavior Checklist (OBC). The neck pain and function will be recorded with the Core Outcome Measure Index (COMI). A Chi-square test and Spearman correlation analysis will used for statistical analysis.
Status | Completed |
Enrollment | 144 |
Est. completion date | June 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - be Adnan Menderes University student - female gender - express consent to participate voluntarily in the study Exclusion Criteria: - with recent trauma to head and face, - history of systematic diseases and neurological disorders - currently an ongoing orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Turkey | Gul Oznur KARABICAK | Aydin |
Lead Sponsor | Collaborator |
---|---|
Aydin Adnan Menderes University |
Turkey,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fonseca Anamnestic Index | Fonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): "yes (10 points)", "sometimes (5 points)" and "no (0 points)". The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19). | baseline | |
Secondary | Oral parafunction | Oral behaviors checklist is a self-report questionnaire for determining the frequency of oral parafunctional behaviors which are any abnormal behavior or functioning of the oral structures and associated muscles in the past one month. Original questionnaire consists of 21items, 2 items for oral behaviors during sleep, and 19 items for oral behaviors during waking hours. In this study the questionnaire was modified and two of the questions were exctracted due to study of Hayek et al25. Each item is scored from 0-4 based on the frequency of activity performed: a score of 0=none of the time; a score of 1=a little of the time; a score of 2=some of the time; a score of 3=most of the time and score of 4=all the time; with a range of 0-76 18.The sum of scoring had the following scheme: none = 0, low = 1-16, and high = 17-76 (20). | baseline | |
Secondary | Neck pain and function | The COMI-neck is a short, self-administered outcome instrument consisting of just seven items to evaluate the five dimensions pain, neck-related function, symptom-specific well-being, general quality of life, and disability (social and work) (21,22). The two pain items use a 0-10 graphic rating scale; all other items use a 5-point adjective scale. For COMI summary score, each of the domain scores is transformed to a 0-10 scale and these are then averaged to give a score ranging from 0 to 10, with higher scores indicating a worse status (23). | baseline |
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