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临床试验/NCT06339736
NCT06339736已完成不适用

Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders

University of Pisa1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Evaluation of the impact of muscular pain on oral health

研究概览

简要总结

The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes.

详细描述

Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD between January 2022 and December 2022 were enrolled. All the study participants signed an informed consent form to be included in the study.

Two study groups were identified:

  • M-TMD group, including patients with a diagnosis of muscular TMDs;
  • A control group of subjects with a negative history for TMDs. The inclusion criteria for patients in the M-TMD group were i) males or females >18 years, ii) systemically healthy patients, iii) clinical examination revealing a diagnosis of muscular TMD and/or positive history of muscular TMD, iv) patients willing to give informed consent, and v) compliance to the study follow-up. Patients with i) articular TMDs, ii) chronic diseases, iii) any psychiatric diagnosis under medication, iv) pregnant or lactating, and v) not willing to comply with the study protocol were excluded.

The subjects included in the control group were enrolled among the patients referred to the Unit of Oral Surgery of the Unit of Dentistry and Oral Surgery. The patients in the control group were i) males or females of age > 18 years, ii) systemically healthy patients, iii) clinical examination negative for pain in the masticatory muscles and negative for history of TMDs, and iv) patients willing to give informed consent and to be administered the study questionnaires.

After diagnosis confirmation of M-TMD according to the DC/TMD criteria, the patients were treated with the application of an oral splint on the upper dental arch associated with physio-kinesiotherapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • males or females >18 years of age
  • systemically healthy patients
  • clinical examination revealing a diagnosis of muscular temporo-mandibular joint disorder (TMD) and/or positive history of muscular TMD
  • patients willing to give informed consent, and v) compliance to the study follow-up.

排除标准

  • articular TMDs
  • chronic diseases
  • any psychiatric diagnosis under medication
  • pregnant or lactating females
  • not willing to comply with the study protocol

结局指标

主要结局

Evaluation of the impact of muscular pain on oral health

时间窗: 6 months

Assessment of Oral Health Impact Profile -14 (OHIP-14) questionnaire scores following treatment. Scores range between 0 (absence of oral health impairment) and 56 (severe oral health impact)

Evaluation of the impact of muscular pain on anxiety

时间窗: 6 months

Assessment of General Anxiety Disorder-7 (GAD-7) questionnaire scores following treatment. Scores range from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.

Evaluation of the impact of muscular pain on depression

时间窗: 6 months

Assessment of Patient Health Questionnaire-9 (PHQ-9) questionnaire scores following treatment. score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)

次要结局

  • Changes in muscular pain(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rossana Izzetti

Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator

University of Pisa

研究点 (1)

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