Comparision of low level laser therapy and medicine treatment efficiency on temporomandibular joint disorders
Design
The controlled clinical trials, community-based and pragmatic, parallel group, randomized, Sample size 42 patients with TMD
Settings and conduct
42 patients withTemporomandibular joint disorder were selected from patients admitted to Oral and maxillofacial surgery department of Zahedan university of medical sciences. They were divided into 2 group randomly . Laser group patients were treated with low lavel laser and control group were treated with medicine.
Participants/Inclusion and exclusion criteria
15 to 45 years old patients that have at least one of TMD criteria
Intervention groups
1-Low level laser therapy : The patient were treated for a period of one month, three times a week with a low-level laser.
2-Drug treatment: The patient were received a megafen drug for 5 days, three times a day.
Main outcome variables
Mean score for pain ; Mean score for pain in touch; Mean size of mouth maximum opening ; Clicking
General information
Reason for update
Acronym
TMD : Temporomandibular joint disorder
IRCT registration information
IRCT registration number:IRCT20161107030761N3
Registration date:2018-02-08, 1396/11/19
Registration timing:retrospective
Last update:2018-02-08, 1396/11/19
Update count:0
Registration date
2018-02-08, 1396/11/19
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
Personal
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparation Evaluation of effect of low-level laser therapy and drug on temporomandibular joint disorders
Public title
Effect of laser and drugs on temporomandibular joint disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15 to 45 years old
Pain of temporomandibular joint region
Limit of oral maximum opening
Limit of mandible lateral movement
Clicking
Exclusion criteria:
Systemic disease
History of trauma or surgery in temporomandibular joint region
No patient cooperation
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Flip a coin were used to randomize samples.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
East Azadegan Ave., Dental School
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.ZAUMS.REC.1396.247
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
first visit, one week later, two weeks later and four weeks later
Method of measurement
Using visual analog scale
2
Description
Clicking
Timepoint
first visit, one week later, two weeks later and four weeks later
Method of measurement
Using Stethoscope while opening of the mouth
3
Description
Limit of mouth opening
Timepoint
first visit, one week later, two weeks later and four weeks later
Method of measurement
Measuring of maximum mouth opening by ruler
4
Description
Touch sensitivity
Timepoint
first visit, one week later, two weeks later and four weeks later
Method of measurement
By touch of maseter and temporalis muscles and temporomandibular joint.
Secondary outcomes
empty
Intervention groups
1
Description
Laser group: After first visit, 4 points around the joint will be radiated by a diode laser fo 40 seconds and this treatment will go on fo 4 weeks(3 time a week) .
Category
Treatment - Other
2
Description
Treatment by drug group: After first visit, 15 capsules of megaphen as 3 in a day will be prescripted.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan university of medical sciences
Full name of responsible person
Sirous Risbaf fakour
Street address
College of dentistry , Eastern Azadegan St. , Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
s-risbaf@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nourmohammad Bakhshani
Street address
ZaUMS Main campus, Jenat Blvd., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3342 5765
Email
nmbakhsha@zdmv.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan university of medical sciences
Full name of responsible person
Niloufar Ghodousi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Fax
Email
Niloofar.qodoosi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sirous Risbaf Fakour
Position
Oral and maxillofacial surgon
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
East Azadegan st. - Kooye tir andazi - zahedan college of dentistry
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Fax
Email
s_risbaf@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Niloufar Ghodousi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St., Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 935 516 7380
Fax
Email
niloofar.qodoosi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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