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Набор скоро начнётся NCT07371143

Turkish Version of Helkimo Clinical Dysfunction Index

— Наблюдательное Temporomandibular Disorder (TMD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales.
Кому может быть актуально
Состояния в реестре: Temporomandibular Disorder (TMD). Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Turkish Adaptation, Validity, and Reliability of the Helkimo Clinical Dysfunction Index

Обзор

This study aimed to translate the Helkimo Clinical Dysfunction Index (HCDI) into Turkish and to test its validity and reliability as an outcome measurement method in individuals with temporomandibular dysfunction (TMD). The study included 40 patients. Participants' pain intensity and range of jaw movement were measured, followed by the administration of the HDCI, the Fonseca Anamnestic Index (FAI), and the Mandibular Function Impairment Questionnaire (MFIQ). For test-retest reliability, the same questionnaire was administered again to the same patients two weeks later, and the FAI was used to test the validity of the questionnaire.

Подробное описание

Based on the idea of making the Helkimo Clinical Dysfunction Index (HCDI) available in Turkish, our study aimed to translate this scoring system into Turkish and to test its validity and reliability as an outcome measurement method in individuals with temporomandibular dysfunction (TMD). The study aimed to include 40 patients. Pain intensity during palpation and chewing was measured using a numerical pain rating scale (NPRS), and range of jaw movement was measured using a linear ruler. Participants were then administered the HCDI, the Fonseca Anamnestic Index (FAI), and the Mandibular Function Impairment Questionnaire (MFIQ). To assess test-retest reliability, the same questionnaire was administered again to the same patients after two weeks. The FAI was used to test the validity of the questionnaire.

Вмешательства

  • Другое Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales
    The intervention includes a detailed clinical assessment and a series of questionnaires. Participants will provide demographic data, trauma, and surgical history. Clinical evaluation includes the measurement of pain and jaw movements. Subjective symptoms will be assessed using the Numerical Pain Rating Scale (NPRS), linear ruler, Fonseca Anamnestic Index (FAI), and Mandibular Function Impairment Questionnaire (MFIQ). The Turkish version of the Helkimo Index will be administered to test its valid

Первичные конечные точки

  • Internal Consistency of the Turkish Helkimo Clinical Dysfunction Index [Срок оценки: At baseline (Day 0).]
Вторичные конечные точки (5)
  • Turkish Version of the Helkimo Clinical Dysfunction Index [Срок оценки: Baseline (Day 0) and 14 days after the baseline assessment for test-retest reliability.]
  • Numeric Pain Rating Scale (NPRS) [Срок оценки: Baseline (Day 0) and 14 days after the baseline assessment.]
  • Range of Jaw Movement [Срок оценки: Baseline (Day 0) and 14 days after the baseline assessment.]
  • Mandibular Function Impairment Questionnaire (MFIQ) Score [Срок оценки: Baseline (Day 0) and 14 days after the baseline assessment.]
  • Fonseca Anamnestic Index (FAI) Score [Срок оценки: Baseline (Day 0) and 14 days after the baseline assessment.]

Критерии участия

Критерии включения

  • Being between 18 and 60 years of age and having been diagnosed with TMB,
  • The person must be a volunteer to participate in the study,
  • The native language must be Turkish.

Критерии исключения

  • Having a history of malignant conditions, trauma, or surgery in the cranial and cervical region,
  • Inability to cooperate,
  • Regular use of analgesic and anti-inflammatory drugs,
  • Having dentofacial anomalies,
  • Having active inflammatory arthritis,
  • Having metabolic diseases (gout, osteoporosis, Cushing's disease, and hyper/hypoparathyroidism),
  • Having connective tissue, rheumatological (systemic lupus erythematosus and scleroderma), and hematological disorders (anemia and leukemia),
  • Having a diagnosed psychiatric illness,
  • Having received physical therapy related to TMB less than 6 months ago,
  • Not being a native language of Turkish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Umay Private Oral and Dental Health Clinic — Istanbul

Публикации

  • Yildiz NT, Alkan A, Kulunkoglu BA. Validity and Reliability of the Turkish Version of Mandibular Function Impairment Questionnaire. Cranio. 2024 Mar;42(2):160-170. doi: 10.1080/08869634.2021.2004715. Epub 2021 Nov 18. PMID 34789075
  • Stegenga B, de Bont LG, de Leeuw R, Boering G. Assessment of mandibular function impairment associated with temporomandibular joint osteoarthrosis and internal derangement. J Orofac Pain. 1993 Spring;7(2):183-95. PMID 8358365
  • Kaynak BA, Tas S, Salkin Y. The accuracy and reliability of the Turkish version of the Fonseca anamnestic index in temporomandibular disorders. Cranio. 2023 Jan;41(1):78-83. doi: 10.1080/08869634.2020.1812808. Epub 2020 Aug 25. PMID 32840464
  • Bevilaqua-Grossi D, Chaves TC, de Oliveira AS, Monteiro-Pedro V. Anamnestic index severity and signs and symptoms of TMD. Cranio. 2006 Apr;24(2):112-8. doi: 10.1179/crn.2006.018. PMID 16711273
  • van der Weele LT, Dibbets JM. Helkimo's index: a scale or just a set of symptoms? J Oral Rehabil. 1987 May;14(3):229-37. doi: 10.1111/j.1365-2842.1987.tb00714.x. PMID 3474383
  • Alonso-Royo R, Sanchez-Torrelo CM, Ibanez-Vera AJ, Zagalaz-Anula N, Castellote-Caballero Y, Obrero-Gaitan E, Rodriguez-Almagro D, Lomas-Vega R. Validity and Reliability of the Helkimo Clinical Dysfunction Index for the Diagnosis of Temporomandibular Disorders. Diagnostics (Basel). 2021 Mar 8;11(3):472. doi: 10.3390/diagnostics11030472. PMID 33800185
  • Çınar, F., Şengül, H., Çapar, H., Çakmak, C., & Bilge, Y. (2018). Perception of health news: a scale development study. J Acad Res Nurs, 4(3), 164-171.
  • Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29. PMID 15928561

Идентификаторы

NCT: NCT07371143 · 27.03.2025/61

Первоисточники (государственные реестры)

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