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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06053723
Other study ID # 2023-54
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2023
Est. completion date September 15, 2023

Study information

Verified date September 2023
Source Bandirma Onyedi Eylül University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date September 15, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
Numeric Pain Scale
It is a simple, reliable and short-term method that is frequently used to measure pain intensity in the clinic.
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.

Locations

Country Name City State
Turkey Bandirma Onyedi Eylul University Balikesir

Sponsors (1)

Lead Sponsor Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bruxism evaluation 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. April 2023- September 2023
Primary Maximum mouth opening Maximum pain-free mouth opening was measured with a 15 cm ruler April 2023- September 2023
Primary Severity of Temporomandibular dysfunction 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). April 2023- September 2023
Primary Pain intensity 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. April 2023- September 2023
Primary Jaw Functionality 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. April 2023- September 2023
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