This study investigated the efficacy of low-level laser therapy (LLLT)as an adjunctive technique for the management of temporomandibular joint disorders.
In a double-blind clinical trial, 30 patients with tmd were randomly divided into laser ,sham laser and no laser groups.occlusal splint fabricated for all patients.
The patients in the laser group received irradiation from an 980nm which was applied on four points around the TMJs and on painful muscles two times a week for 4 weeks ,in the sham laser group the treatment was the same as that in the laser group, but with laser simulation and in the third group patient just received splint.All patients were subjected to clinical examination using Helkimo Dysfunction Index (HDI)to assess the degree of TMD before and after treatment.
Inclusion criteria :patients with pain in muscles,tmj,click
exclusion criteria:intracapsular disorders,anatomical disorders,Artrosis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031016933N1
Registration date:2014-10-09, 1393/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-09, 1393/07/17
Registrant information
Name
Mohammad Bayani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3193
Email address
bayani_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-07-05, 1393/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Low level laser therapy as an adjunctive technique in the treatment of temporomandibular disorders
Public title
Laser effectiveness on the pain and masticatory performance of patients with TMD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :patients with pain in muscles,tmj,click
Exclusion criteria:intracapsular disorders,anatomical disorders,Artrosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
14336-71348
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
CT_P_92_5100
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
TMJ pain
Timepoint
Before splint therapy and laser application, after splint therapy and laser application
Method of measurement
Helkimo index
2
Description
Muscle pain
Timepoint
Before splint therapy and laser application, after splint therapy and laser application
Method of measurement
Helkimo index
3
Description
Motion index
Timepoint
Before splint therapy and laser application, after splint therapy and laser application
Method of measurement
Helkimo index
4
Description
TMJ function
Timepoint
Before splint therapy and laser application, after splint therapy and laser application
Method of measurement
Helkimo index
5
Description
Pain on movement of mandible
Timepoint
Before splint therapy and laser application, after splint therapy and laser application
Method of measurement
Helkimo index
Secondary outcomes
empty
Intervention groups
1
Description
Sham laser in control group
Category
Treatment - Devices
2
Description
No laser in control group
Category
Treatment - Devices
3
Description
Laser in intervention group
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry of Shiraz Universsity of Medical Sciences
Full name of responsible person
mohammad bayani Postgraduate Student in Prosthodontics
Street address
School of Dentistry, Shiraz University of medical Sciences , Ghasrodasht Street , Qom Abad , Shiraz , Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Bayani
Position
Postgraduate Student in Prosthodontics
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
71348-14336
Phone
+98 71 3235 2559
Fax
Email
Bayani_m@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Bayani
Position
Postgraduate Student in Prosthodontics
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
71348-14336
Phone
+98 71 3235 2559
Fax
Email
Bayani_m@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Bayani
Position
Postgraduate Student in Prosthodontics
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street, Shiraz, Iran.
City
Shiraz
Postal code
71348-14336
Phone
+98 71 3235 2559
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)