- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04842136
Factors Affecting Patients With Myofascial Temporomandibular Disorders
Comparison of Factors Affecting Patients With a Myofascial Temporomandibular Disorder With and Without Sleep Bruxism
연구 개요
상태
개입 / 치료
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Gaziantep, 칠면조
- Abdulkadir Konukoglu Healthy Life Center
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Şanlıurfa, 칠면조
- Umut Rehabilitation Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analogue Scale
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Aysenur Tuncer, Hasan Kalyoncu University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2020/026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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