Determining the effect of self-care treatment in improving the symptoms of Temporomandibular Disorders in Rheumatoid Arthritis patients treated with drugs.
Design
Phase 2 clinical trial
Settings and conduct
The symptoms of Temporomandibular Disorders of a patient with Rheumatoid Arthritis referring to a Rheumatologist's office will be examined by a trained examiner in the first visit. Pain intensity will be evaluated using a Numerical Analog Scale. Then the necessary "self-care" training will be given. 2 months later, the patient will be examined again, similar to the first session, and the symptoms will be recorded.
Participants/Inclusion and exclusion criteria
A patient with Rheumatoid Arthritis under medical treatment with Temporomandibular Disorders
Intervention groups
The pain intensity of patients suffering from Rheumatoid Arthritis with Temporomandibular Disorders will be evaluated using a Numerical Analog Scale. Then the necessary "self-care" training will be given. 2 months later, the patient will be examined again, similar to the first session, and the symptoms will be recorded.
Main outcome variables
Temporomandibular Disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221113056489N1
Registration date:2022-11-19, 1401/08/28
Registration timing:registered_while_recruiting
Last update:2022-11-19, 1401/08/28
Update count:0
Registration date
2022-11-19, 1401/08/28
Registrant information
Name
hosna bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 0450
Email address
bahrami.h1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-19, 1401/08/28
Expected recruitment end date
2023-02-17, 1401/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care in improving the symptoms of Temporomandibular Disorders in drug-treated Rheumatoid Arthritis patients
Public title
The effect of Self-care in improving symptoms of Temporomandibular Disorders in Rheumatoid Arthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Rheumatoid Arthritis under anti-rheumatoid drug treatment with Temporomandibular Disorder
No previous treatment for Temporomandibular Disorders
Exclusion criteria:
History of jaw trauma
History of head, mouth and neck neoplasia
History of maxillofacial surgery
Changing the therapeutic dose of Rheumatoid Arthritis during the follow-up period
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shcool of Dentistry, Tehran Univrsity of Medical Sciences
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2022-05-28, 1401/03/07
Ethics committee reference number
IR. TUMS.DENTISTRY.REC.1401.034
Health conditions studied
1
Description of health condition studied
Temporomandibular joint Disorders
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint-pain-dysfunction syndrome
Primary outcomes
1
Description
Temporomandibular Disorders
Timepoint
Measuring symptoms of Temporomandibular Disorders at the beginning of the study (before the start of the intervention) and 2 months after self-care training.
Method of measurement
Numerical Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In Rheumatoid Arthritis patients under drug treatment, the symptoms of Temporomandibular Disorders will be examined by a trained examiner, and the diagnosis of Temporomandibular Disorders will be confirmed with the criteria of the RDC-TMD questionnaire, and the severity of dysfunction will be recorded based on the Helkimo clinical criteria. Patients are then asked to rate the pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents maximum pain. After recording symptoms, the necessary "self-care" training will be given in the form of a short seminar, along with skills training provided through demonstrations, exercises between sessions, and structured feedback during sessions and phone calls. Self-care includes: education (about the socio-biology model of TMD, chronic pain, multifaceted aspects of the cause of TMD, management methods, and the logic of self-management), bilateral chewing, limitation of mouth opening (opening the mouth within the range of the patient's pain threshold ), diet control (avoid eating hard food), yawn control (opposite pressure on the back of both hands under the chin), thermal modalities (use of moist heat (twice a day for 20 minutes each time) and ice compresses) 1 time and 10 minutes each time) alone or together), massage therapy (touching and caressing the muscles along them), controlling parafunctional behaviors (putting their tongue behind the front teeth of the upper jaw, such as when say "N" and then close your mouth and when the lower jaw was in a resting position, leave a few millimeters of space between the occlusion surfaces of the upper and lower teeth while the lips are slightly in contact with each other (free space) (Patients will be instructed to maintain this relaxed position at all times at rest, except when eating or talking and to avoid involuntary muscle contraction with teeth in central occlusion). Then two weeks later, by phone, the patient will be monitored to ensure that the training is done correctly, and 2 months later, an examination will be done again, similar to the first session, and the severity of the symptoms will be recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatologist office
Full name of responsible person
Dr Tahere Faezi
Street address
Third floor, No. 58, Ziba St, Shariati St
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 2288 9659
Email
bahrami.h1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Khorshidi
Street address
Research Center of School of Dentistry, Tehran University of Medical Seiences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3102
Email
stat@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hosna Bahrami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 83 3429 0450
Fax
Email
bahrami.h1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hosna Bahrami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 83 3429 0450
Fax
Email
bahrami.h1994@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hosna Bahrami
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 83 3429 0450
Fax
Email
bahrami.h1994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After deidentifying the patient's demographic information, the results obtained after the treatment can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions will be available
Under which criteria data/document could be used
After deidentifying the patient's demographic information, the results obtained after the treatment can be shared
From where data/document is obtainable
Faculty of Dentistry, Tehran University of Medical Sciences
Hosna Bahrami
09186796325
bahrami.h1994@gmail.com
What processes are involved for a request to access data/document
The access period starts 12 months after receiving the request