Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders

NCT06339736 | Completed

• 1 other identifier: 23815
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TMD; TMD/Orofacial Pain

Keywords

Temporomandibular Joint Disorders; Quality of Life; Oral Health; Oral Health-Related Quality of Life

Outcome Measures

Primary Outcomes (3)

• Evaluation of the impact of muscular pain on oral health

  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)

  6 months

• Evaluation of the impact of muscular pain on anxiety

  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.

  6 months

• Evaluation of the impact of muscular pain on depression

  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)

  6 months

Secondary Outcomes (1)

• Changes in muscular pain

  6 months

Study Arms (2)

M-TMD group

Patients with a diagnosis of muscular TMDs performed according to DC/TMD criteria

Other: Questionnaires administered to all study participants

CTRL group

A control group of subjects with a negative history for TMDs

Other: Questionnaires administered to all study participants

Interventions

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.

CTRL group; M-TMD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 56126, Italy

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 1, 2024
• Study Start: January 10, 2022
• Primary Completion: February 28, 2025
• Study Completion: March 28, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

IT (1)