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Bruxism and Severity of Temporomandibular Dsyfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06053723
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : September 29, 2023
Sponsor:
Information provided by (Responsible Party):
Hazel Çelik Güzel, Bandırma Onyedi Eylül University

Study Description
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Brief Summary:
The aim of the study was to investigate the effect of bruxism on Temporomanbular joint functionality and dysfunction severity in individuals with Temporomandibular Dysfunction (TMD).

Condition or disease Intervention/treatment
Temporomandibular Dysfunction Other: Fonseca's Anamnestic Questionnaire Other: Numeric Pain Scale Other: Jaw Functionality Limitation Scale-20

Detailed Description:
The study included 91 individuals aged 20-55 years with TMD. Participants who volunteered to participate in the study signed the Informed Consent Form and completed the Descriptive Data Form including demographic characteristics. The presence of bruxism in individuals with TMD was questioned and the maximum mouth opening measurement was recorded. TMD severity was assessed by Fonseca's Anamnestic Questionnaire (FAQ), pain severity was assessed by Numeric Pain Scale (NPS), and masticatory and TMJ functioning was assessed by JAW Functional Limitation Scale-20 (JFLS-20). The evaluations of the participants were performed only once.
Study Design
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Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Effect of Bruxism on Masticatory Functionality and Severity of Temporomandibular Dsyfunction: A Cross-sectional Study
Actual Study Start Date : April 15, 2023
Actual Primary Completion Date : September 1, 2023
Actual Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Fonseca's Anamnestic Questionnaire
    The questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress.
  • Other: Numeric Pain Scale
    It is a simple, reliable and short-term method that is frequently used to measure pain intensity in the clinic.
  • Other: Jaw Functionality Limitation Scale-20
    It includes a total of 20 items, with "0" indicating no limitation and "10" indicating severe limitation in each item, about the function of the TMJ during different activities, difficulty in chewing and jaw limitation.

Outcome Measures
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Primary Outcome Measures :
  1. Bruxism evaluation [ Time Frame: April 2023- September 2023 ]
    Sleep bruxism reported by the individual was recorded. As clinical diagnostic criteria for bruxism; the presence of regular or frequent teeth clenching and grinding sounds followed by pain or fatigue in the jaw muscles on waking up in the morning, temporal headache, masseter muscle hypertrophy, abnormal tooth abrasion and/or jaw locking were questioned and the presence of one or more clinical findings was recorded as bruxism.

  2. Maximum mouth opening [ Time Frame: April 2023- September 2023 ]
    Maximum pain-free mouth opening was measured with a 15 cm ruler

  3. Severity of Temporomandibular dysfunction [ Time Frame: April 2023- September 2023 ]
    Fonseca's Anamnestic Questionnaire (FAQ) was used. The questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress. As a result of the questionnaire, the presence of TMD is accepted in patients with a score of 25 and above, and the severity can be classified as mild TMJ disorder (25-45), moderate TMJ disorder (50-65) and severe TMJ disorder (70-100).

  4. Pain intensity [ Time Frame: April 2023- September 2023 ]
    Numeric Pain Scale (NAS): It is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity. The patient is told that the most severe pain he/she feels in the TMJ region is 10, and if there is no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region.

  5. Jaw Functionality [ Time Frame: April 2023- September 2023 ]
    Jaw Functionality Limitation Scale-20 was used. It includes a total of 20 items, with "0" indicating no limitation and "10" indicating severe limitation in each item, about the function of the TMJ during different activities, difficulty in chewing and jaw limitation. As a result of the questionnaire, it was reported that TMJ function was limited in individuals with a score of 5 and above.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
diagnosed with TMD
Criteria

Inclusion Criteria:

  • Aged between 20 and 55 years,
  • Diagnosed with TMD,
  • volunteer to participate in the study

Exclusion Criteria:

  • having a non-reduced disc problem,
  • surgical operation due to spine, abdomen and/or TMJ problem,
  • trauma, cancer, neurological problems, congenital anomalies, musculoskeletal system problems,
  • systemic disease,
  • facial paralysis
  • Less than 6 months of receiving any treatment related to the spine and TMJ
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053723


Locations
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Turkey
Bandirma Onyedi Eylul University
Balıkesir, Turkey
Sponsors and Collaborators
Bandırma Onyedi Eylül University
More Information
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Responsible Party: Hazel Çelik Güzel, Assist. Prof. Dr, Bandırma Onyedi Eylül University
ClinicalTrials.gov Identifier: NCT06053723    
Other Study ID Numbers: 2023-54
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 29, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hazel Çelik Güzel, Bandırma Onyedi Eylül University:
temporomandibular dysfunction
bruxism
chewing functionality
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Bruxism
Tooth Diseases
Stomatognathic Diseases
Craniomandibular Disorders
 Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Myofascial Pain Syndromes