Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders

NCT ID: NCT06339736

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2025-03-28

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.

Detailed Description

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

Conditions

TMD; TMD/Orofacial Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

M-TMD group

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

Questionnaires administered to all study participants

Intervention Type: 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

A control group of subjects with a negative history for TMDs

Questionnaires administered to all study participants

Intervention Type: 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.

Interventions

Questionnaires administered to all study participants

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Rossana Izzetti

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pisa

Pisa, , Italy

Countries

Italy

Other Identifiers

23815

Identifier Type: -

Identifier Source: org_study_id