Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
- Conditions
- TMDTMD/Orofacial Pain
- Interventions
- Other: Questionnaires administered to all study participants
- Registration Number
- NCT06339736
- Lead Sponsor
- University of Pisa
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- articular TMDs
- chronic diseases
- any psychiatric diagnosis under medication
- pregnant or lactating females
- not willing to comply with the study protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CTRL group Questionnaires administered to all study participants A control group of subjects with a negative history for TMDs M-TMD group Questionnaires administered to all study participants Patients with a diagnosis of muscular TMDs performed according to DC/TMD criteria
- Primary Outcome Measures
Name Time Method Evaluation of the impact of muscular pain on oral health 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)
Evaluation of the impact of muscular pain on anxiety 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.
Evaluation of the impact of muscular pain on depression 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 Outcome Measures
Name Time Method Changes in muscular pain 6 months Changes in muscular pain following treatment assessed through pressure pain threshold
Trial Locations
- Locations (1)
University of Pisa
🇮🇹Pisa, Italy