Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339736
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-03-21
Brief Title:
Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
Official Title:
Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ampgt18 years ii systemically healthy patients iii clinical examination revealing a diagnosis of muscular TMD andor 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 ampgt 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 DCTMD 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
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 ampgt18 years ii systemically healthy patients iii clinical examination revealing a diagnosis of muscular TMD andor 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 ampgt 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 DCTMD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None