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NCT Number: NCT06339736

Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa

Pisa, 56126, Italy

About this study

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.

The patients were administered OHIP-14, PHQ-9, and GAD-7 questionnaires to compare scores in the M-TMD patients versus healthy subjects

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Questionnaires administered to all study participants

Other

Ten treatment sessions were performed, which initially involved muscular stretching and relaxation exercises and then strengthening and endurance exercises to achieve stabilization. An oral splint was applied to he upper dental arch.

Primary outcomes

  1. Evaluation of the impact of muscular pain on oral health

    Time frame: 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)

  2. Evaluation of the impact of muscular pain on anxiety

    Time frame: 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.

  3. Evaluation of the impact of muscular pain on depression

    Time frame: 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)

Secondary outcomes

  1. Changes in muscular pain

    Time frame: 6 months

    Changes in muscular pain following treatment assessed through pressure pain threshold

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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