Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06339736 |
| Other study ID # |
23815 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2022 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
March 2024 |
| Source |
University of Pisa |
| Contact |
Rossana Izzetti |
| Phone |
+39050993037 |
| Email |
rossana.izzetti[@]unipi.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
