Clinical trial NCT06339736: Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
Official title: Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TMD
TMD/Orofacial Pain
Keywords: Temporomandibular Joint Disorders
Quality of Life
Oral Health
Oral Health-Related Quality of Life
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD

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 \&amp;gt;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 \&amp;gt; 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

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

Primary outcomes:
measure: Evaluation of the impact of muscular pain on oral health
timeFrame: 6 months
measure: Evaluation of the impact of muscular pain on anxiety
timeFrame: 6 months
measure: Evaluation of the impact of muscular pain on depression
timeFrame: 6 months
Secondary outcomes:
measure: Changes in muscular pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
References: