This is a randomized clinical trial aimed to compare the treatment efficacy of splint and electrical stimulation on temporomandibular joint disorders in 40 patients suffering from temporomandibular joint disorders in 2016-2017. Inclusion criteria are age of 16-45 years, having normal teeth except the third molar tooth and Angle Class I occlusion and having occlusal interferences and exclusion criteria are having systemic disease, organic disorders of temporomandibular joint, using antipsychotic drugs within the last two weeks, history of orthodontic treatment and having any prosthesis. After inclusion in the study, the patients will be randomly divided into two equal groups, splint group and electrical stimulation group. Patients in the splint group will be given a maxillary occlusal splint and they will use it for 8 weeks; in the first 6 weeks they will use it 24 hours a day and from the 6th week till the end of the 8th week its usage will be reduced so that at the end of the 8th week they will use it only while sleeping; at the end of the 8th week the mean pain score will be calculated using Visual Analog Scale. In the electrical stimulation group, the patients will receive 10 sessions of treatment through stimulation of the skin of the temporomandibular joint area; each session will last 30 minutes with a frequency of 80 Hz; at the end of the 10th session the mean pain score will be calculated using Visual Analog Scale. Finally, the data will be compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110730761N1
Registration date:2016-12-15, 1395/09/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-15, 1395/09/25
Registrant information
Name
sirous risbaf fakour
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 4003
Email address
s_risbaf@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the treatment efficacy of splint and electrical stimulating on temporomandibular joint disorders
Public title
The effect of splint and electrical stimulating on temporomandibular joint disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 16-45 years; having normal teeth except the third molar tooth and Angle Class I occlusion and having occlusal interferences.
Exclusion criteria: having systemic disease; organic disorders of temporomandibular joint; using antipsychotic drugs within the last two weeks; history of orthodontic treatment and having any prosthesis.
Age
From 16 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We will use the random number table for randomization of the patients. In this table, even numbers will be assigned to splint group and odd numbers to electrical stimulation group; reading direction of the numbers will be left-to-right.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2016-10-23, 1395/08/02
Ethics committee reference number
ir.zaums.rec.1395.189
Health conditions studied
1
Description of health condition studied
Temporomandibular joint disorders
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
mean pain score
Timepoint
at the end of 8th week in the splint group and at the end of 10th session in the electrical stimulation group
Method of measurement
Using Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Splint group: Using splint for 8 weeks; in the first 6 weeks it will be used 24 hours a day and from the 6th week till the end of the 8th week its usage will be reduced so at the end of 8th week it will be used only while sleeping
Category
Treatment - Other
2
Description
Electrical stimulation group: the patients will receive 10 sessions of treatment through stimulation of the skin of the temporomandibular joint area; each session will last 30 minutes with a frequency of 80 Hz
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Ghayoor
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Deputy of research and technology, Zahedan University of Medical Sciences campus, Jannat Blv, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Ghayoor
Position
Dentistry Student
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5715
Fax
Email
s-risbaf@zaums.ac.irmostafa7203603@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sirus Risbaf
Position
Associate Professor
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5715
Fax
Email
Sri3baf@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Ghayoor
Position
Dentistry Student
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5715
Fax
Email
s-risbaf@zaums.ac.irmostafa7203603@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)