Evaluating the effect of self-management in improving aural symptoms in patients with temporomandibular disorders
Design
Phase 2 clinical trial on 42 patients
Settings and conduct
Symptoms of Temporomandibular Disorders Patients who have ear symptoms and will refer to the Department of Oral and Maxillofacial Diseases Faculty of Dentistry of Tehran University of Medical Sciences will be examined and recorded 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 weeks, 1 and 2 months later, again similar to the first session, the patient will be examined and the symptoms will be recorded.
Participants/Inclusion and exclusion criteria
Temporomandibular joint disorder, earache alone or accompanied by at least one ear symptom including tinnitus, ear fullness, having parafunctional habits, absence of inflammatory and infectious ear lesions, ear or head and neck neoplastic lesions, ear cystic lesions History of head and neck trauma, history of head and face surgery, pregnancy, neurological disorders
Intervention groups
Referees to the Department of Oral and Maxillofacial medicine, Faculty of Dentistry, Tehran University of Medical Sciences, with complaints of Temporomandibular joint disorders.
Main outcome variables
Temporomandibular Disorders
General information
Reason for update
Acronym
TMD
IRCT registration information
IRCT registration number:IRCT20090118001559N12
Registration date:2022-11-23, 1401/09/02
Registration timing:registered_while_recruiting
Last update:2022-11-23, 1401/09/02
Update count:0
Registration date
2022-11-23, 1401/09/02
Registrant information
Name
Farzaneh Aghahoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6611 2437
Email address
aghahose@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of self-care on ear symptoms in patients with temporomandibular joint disorders
Public title
The effect of self-care on ear problems in people with jaw problems
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Temporomandibular joint disorder
Earache alone (with NRS=3) or accompanied by at least one of the ear symptoms including tinnitus, ear fullness
having parafunctional habits (such as bruxism during sleep or waking up, biting nails or lips and resting the hand under the chin)
Exclusion criteria:
Inflammatory and infectious lesions of the ear
Neoplastic lesions of the ear or head and neck
Cystic ear lesions
History of head and neck trauma
History of head and face surgery
pregnancy
neurological disorders
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
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
۱۴۳۹۹۵۵۹۹۱
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.104
Health conditions studied
1
Description of health condition studied
otalgia
ICD-10 code
ICD-10 code description
K07.6H92.0
2
Description of health condition studied
tinnitus
ICD-10 code
ICD-10 code description
H93.1
3
Description of health condition studied
Temporomandibular joint disorders
ICD-10 code
ICD-10 code description
K07.6
Primary outcomes
1
Description
Temporomandibular joint disorders
Timepoint
At the beginning of the study and 2 weeks later, the first month, the second month and the third month
Method of measurement
Numerical Analogue Scale
Secondary outcomes
1
Description
Changes in earache intensity
Timepoint
The beginning of the study, the first 2 weeks, the first month, the second month and the third month
Method of measurement
Numerical Analogue Scale
2
Description
changes in tinnitus
Timepoint
The beginning of the study, the first 2 weeks, the first month, the second month and the third month
Method of measurement
tinnitus handicap inventory
3
Description
changes in ear fullness
Timepoint
The beginning of the study, the first 2 weeks, the first month, the second month and the third month
Method of measurement
Numerical Analogue Scale
Intervention groups
1
Description
Intervention group: In patients who have jaw problems and also complain of ear pain, ear fullness or tinnitus, 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 Helkimo's clinical criteria will be registered. 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. Tinnitus is evaluated by tinnitus handicap inventory and severity of earache and ear fullness by grading from 0 to 10. 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, 1 month and 2 months later, the patient will be monitored to ensure that the training is done correctly, and again, similar to the first session, the examination will be done and the severity of the symptoms will be recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shcool of Dentistry, Tehran Univrsity of Medical Sciences
Full name of responsible person
Parmiss omidsalar
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 6739 5100
Email
parmiss.omidsalar@yahoo.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 Sciences, Enghelab Sq., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
parmiss.omidsalar@yahoo.com
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
Parmiss Omidsalar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 2290 7161
Email
parmiss.omidsalar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Aghahosseini
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
chool of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4000
Email
aghahose@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parmiss omidsalar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 2290 7161
Email
parmiss.omidsalar@yahoo.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
For 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, Dr. Parmiss Omidsalar
What processes are involved for a request to access data/document
The access period starts 12 months after receiving the request