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.

Study Overview

• Status: Recruiting
• Conditions: TMD; TMD/Orofacial Pain
• Intervention / Treatment: Other: Questionnaires administered to all study participants

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

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Rossana Izzetti; Phone Number: +39050993037; Email: rossana.izzetti@unipi.it

Study Locations

• Italy
  • Pisa, Italy, 56126
    • Recruiting
    • University of Pisa
    • Contact: Rossana Izzetti; Phone Number: +39050993037; Email: rossana.izzetti@unipi.it
    • Principal Investigator: Rossana Izzetti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
M-TMD group; Patients with a diagnosis of muscular TMDs performed according to DC/TMD criteria	Other: 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.
CTRL group; A control group of subjects with a negative history for TMDs	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the impact of muscular pain on oral health	Assessment of Oral Health Impact Profile -14 (OHIP-14) questionnaire scores following treatment	6 months
Evaluation of the impact of muscular pain on anxiety	Assessment of General Anxiety Disorder-7 (GAD-7) questionnaire scores following treatment	6 months
Evaluation of the impact of muscular pain on depression	Assessment of Patient Health Questionnaire-9 (PHQ-9) questionnaire scores following treatment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscular pain	Changes in muscular pain following treatment assessed through pressure pain threshold	6 months

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Oral Health; Temporomandibular Joint Disorders; Oral Health-Related Quality of Life
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
• Other Study ID Numbers: 23815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No