- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04842136
Factors Affecting Patients With Myofascial Temporomandibular Disorders
Comparison of Factors Affecting Patients With a Myofascial Temporomandibular Disorder With and Without Sleep Bruxism
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
The study was conducted on TMD patients who were willing to participate in the study between January and December 2020.
The case-control study included patients diagnosed with myofascial TMD by dental practitioners at regional hospitals referred for physiotherapy. Total of 200 myofascial TMD patients, comprising 91 identified as SB and 109 as non-SB were included in the study.
The Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales and indexes were used for both groups.
The effect of Sleep Bruxism (SB) on jaw function, neck problems, sleep quality, fatigue, and tension headache were evaluated.
The interactions of these factors and the importance of taking SB into consideration when evaluating and treating patients with TMD were examined.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Gaziantep, Kalkon
- Abdulkadir Konukoglu Healthy Life Center
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Şanlıurfa, Kalkon
- Umut Rehabilitation Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- diagnosis of myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- pain for more than 6 months
- no therapeutic interventions reported for TMD or the neck in the last 6 months
- intellectual capacity to provide informed consent
Exclusion Criteria:
- not meeting the DC/TMD criteria
- diagnosis of psychiatric disease
- history of surgery related to the cervical region and/or TMJ
- cervical and/or TMJ malignancy
- trauma history
- proven specific pathologies such as fracture, or rheumatoid disease
- history of facial paralysis
- pregnancy
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Myofascial Temporomandibular Disorder (TMD) with Sleep Bruxism (SB)
Patients with Myofascial TMD and with sleep bruxism with the diagnosis of regular or frequent teeth grinding sounds during the sleep, and one or more following clinical signs, such as jaw muscle pain or fatigue on waking up in the morning, temporal headache, hypertrophy of the masseter muscle, abnormal tooth wear, and/or jaw locking were included in the group.
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Patients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales.
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Myofascial Temporomandibular Disorder (TMD) without Sleep Bruxism (SB)
Patients with Myofascial TMD without sleep bruxism were included in the group.
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Patients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Visual Analogue Scale
Tidsram: Baseline
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The severity of pain in muscles was measured in centimeters using a 0-10 Visual Analogue Scales (VAS).
The scale ranges from 0 = "no pain at all" to 10 = "intolerable pain"
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Baseline
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Jaw Functional Limitation Scale
Tidsram: Baseline
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The Jaw Functional Limitation Scale-20 was used to assess jaw function in the masticatory system.
The scale consists of a total of 20 items with three constructs.
Each item is scored from 0-10, with 0 indicating no restriction and 10, severe restriction.
A total of ≥5 indicates jaw function limitation.
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Baseline
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Neck Disability Index
Tidsram: Baseline
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Neck problems were assessed with Neck Disability Index (NDI).
It is a scale of 10 sections with total points ranging from 0-50.
Higher scores indicate severe pain, and a score of ≥5 indicates a neck disorder.
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Baseline
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Pittsburgh Sleep Quality Index
Tidsram: Baseline
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The sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI).
The scale comprises a total of 24 items in 7 sub-scales.
The total points of the 19 items that score from 0-21, with a total of ≥5 indicating poor sleep quality.
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Baseline
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Fatigue Severity Scale
Tidsram: Baseline
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The effect of fatigue on functional and behavioral aspects was evaluated by the Fatigue Severity Scale (FSS).
The total score is calculated as the average of the 9 item scores -the lower the total score, the lower the fatigue level.
A cut-off value of ≥4 has been defined for fatigue
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Baseline
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Headache Impact Test
Tidsram: Baseline
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The Headache Impact Test-6 (HİT-6) was used to assess the headache.
The 6 items scale evaluating the frequency, the degree of restriction to daily life and social life, and changes in the mood because of headache.
The total score 50-59 reflects important impact, and scores ≥60 indicate severe impact.
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Baseline
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Aysenur Tuncer, Hasan Kalyoncu University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Patologiska processer
- Sjukdomar i nervsystemet
- Vakna sömnstörningar
- Smärta
- Neurologiska manifestationer
- Ledsjukdomar
- Muskuloskeletala sjukdomar
- Muskelsjukdomar
- Stomatogena sjukdomar
- Tandsjukdomar
- Käksjukdomar
- Kraniomandibulära sjukdomar
- Mandibular sjukdomar
- Myofasciala smärtsyndrom
- Sjukdom
- Dyssomni
- Parasomnier
- Huvudvärk
- Bruxism
- Temporomandibulära ledstörningar
- Temporomandibular Joint Dysfunction Syndrome
- Sömnbruxism
Andra studie-ID-nummer
- 2020/026
Plan för individuella deltagardata (IPD)
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