This study includes 96 patients with nontraumatic temporomandibular joint dislocation attending to Amiraalam hospital emergency ward to determine of outcome measures of three different methods of TMJ reduction. After admitting and confirming the diagnosis,the cases will categorized to 3 groups by simple randomization. Each group will receive different method of reduction (conventional, wrist pivot method and extra oral method). after reduction, physician will fill a check list. Then the failure rate, difficulty of method for patient and physician, duration of reduction and amount of muscle relaxant usage will be compared between these three groups.
General information
Acronym
Temporomandibular joint reduction
IRCT registration information
IRCT registration number:IRCT201304249039N2
Registration date:2013-07-07, 1392/04/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-07, 1392/04/16
Registrant information
Name
Shahin Bastaninezhad
Name of organization / entity
Dep. ENT, AmirAlam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
shahinbastani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome comparison of different methods of Temporomandibular joint reduction in patients suffering from joint dislocation
Public title
Outcome comparison of different methods of Temporomandibular joint reduction in patients suffering from joint dislocation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patients with non traumatic temporomandibular joint disocation attending to Amiraalam hospital in 1391 -92
Exclusion criteria: Patients with concommitent mandibular fracture
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
TUMS research deputy
Street address
Ghods st, Keshavarz blvd
City
Tehran
Postal code
Approval date
2013-03-10, 1391/12/20
Ethics committee reference number
91_04_48_20463_77376
Health conditions studied
1
Description of health condition studied
Temporomandibular joint dislocation
ICD-10 code
S03-0
ICD-10 code description
Dislocation of jaw
Primary outcomes
1
Description
failure of method
Timepoint
at reduction time
Method of measurement
records of physician
Secondary outcomes
1
Description
difficulty of methid for patient
Timepoint
after reduction
Method of measurement
visual analog scale
2
Description
duration of reduction
Timepoint
at the time of reduction
Method of measurement
physician records( in seconds)
3
Description
difficulty of method for physician
Timepoint
after reduction
Method of measurement
visual analog scale
4
Description
need of muscle relaxant
Timepoint
after reduction
Method of measurement
physician records
Intervention groups
1
Description
conventional reduction method
Category
Other
2
Description
Extraoral reduction method
Category
Other
3
Description
wrist pivot reduction method
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiraalam hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Bastaninejad
Street address
ENT Department, Amir'Alam Hospital, North Sadee Avenue
City
Tehran
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
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
Tehran University of Medical Sceinces
Full name of responsible person
Shahin Bastaninejad
Position
Assistant professor of otolaryngology
Other areas of specialty/work
Street address
ENT Department, Amir'alam Hospital, North Sadee Avenue
City
Tehran
Postal code
Phone
+98 21 6670 1768
Fax
Email
shahinbastani@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadi Ardehali
Position
Associated Professor
Other areas of specialty/work
Street address
ENT Departement, Amir'Alam Hospital, North Sadee avenue
City
Tehran
Postal code
Phone
+98 21 6670 3037
Fax
Email
mohamadm@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niloofar Tari
Position
Resident of ENT
Other areas of specialty/work
Street address
ENT Department, Amir'Alam Hospital, North Sadee Avenue
City
Tehran
Postal code
Phone
+98 21 6670 1768
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)