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Comparative Evaluation of Two Methods :Low Level Laser and Laser Acupuncture In Relieving Pain In Patients With Temporomandibular Disorders (A Randomized Clinical Trial)

Protocol summary

Summary
The aim of this study is to comparative the efficacy of low-level of laser therapy (LLLT) and laser acupuncture in the management of pain in patients with temporomandibular joint disorders (TMD). In this randomized, double-blind clinical trial, 45 patients with TMD Will be divided randomly in three groups as follows: laser, laser acupuncture, and placebo. In the laser group, a pulsed 810-nm low-level laser (average power 200 mW) will be applied on the painful points twice a week for a 5-week period. In the placebo group, the treatment will be the same as that in the laser group, but without energy output. In the laser acupuncture group, a pulsed 810-nm low-level laser (average power 200 mW) will be used on acupuncture points (LI4, ST6, ST7) twice a week for a 5-week period. .The patients will be evaluated before laser therapy (T1), after five sessions of laser application (T2), at the end of treatment (T3), and 1 month after the last session (T4). Pain will be measured by using 10-cm Visual Analog Scale (VAS) scores and Maximum mouth opening. Lateral and protrusive mandibular movements , will be measured by the caliber of digitalis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010131710N1
Registration date: 2017-06-01, 1396/03/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Naeeme Daghestani
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 513882950115
Email address
daghestanin901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Science
Expected recruitment start date
2016-11-28, 1395/09/08
Expected recruitment end date
2018-11-29, 1397/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of Two Methods :Low Level Laser and Laser Acupuncture In Relieving Pain In Patients With Temporomandibular Disorders (A Randomized Clinical Trial)
Public title
Laser Therapy In Relieving Pain In Patients With Temporomandibular Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with myogenic orofacial pain; limited mouth opening ; arthralgia ; difficulty chewing ; patients with pain in the myofascial and joint area and either during palpation or jaw movements Exclusion Criteria: Systemic diseases that affect temporomandibular joint ; patients who have received analgesics or anti-stress drugs during the last two weeks ; teeth pulpitis ; children ; pregnant women and nursing mothers ; epilepsy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad Dental School
Street address
School of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Postal code
91735
Approval date
2016-12-28, 1395/10/08
Ethics committee reference number
IR.mums.sd.REC.1394.191

Health conditions studied

1

Description of health condition studied
Temporomandibular Disorders
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint disorders

Primary outcomes

1

Description
pain
Timepoint
before treatment, third week,fifth week, tenth week
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
measure of mouth opening
Timepoint
before treatment, third week,fifth week, tenth week
Method of measurement
caliber of digitalis

2

Description
measure of lateral and protrusive mandibular movements
Timepoint
before treatment, third week,fifth week, tenth week
Method of measurement
caliber of digitalis

Intervention groups

1

Description
In the laser group, a pulsed 810-nm low-level laser (average power 200 mW) are used on painful points two times a week for 5 weeks
Category
Treatment - Other

2

Description
In the laser acupuncture group, a pulsed 810-nm low-level laser (average power 200 mW) are used on acupuncture points (LI4 , ST6 , ST7 ) two times a week for 5 week
Category
Treatment - Other

3

Description
In the placebo group, the treatment is the same as that in the laser group, but without energy output
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad School of Dentistry
Full name of responsible person
Dr Azam Madani
Street address
Mashhad School of Dentistry
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Department of Mashhad University of Medical Sciences
Full name of responsible person
Dr Azam Madani
Street address
Mashhad Dentistry School
City
Mashhad
Grant name
951115
Grant code / Reference number
951115
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Department of Mashhad 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
Mashhad Dentistry School
Full name of responsible person
Dr Azam Madani
Position
prosthodontist
Other areas of specialty/work
Street address
School of Dentistry, Vakilabad Blvd
City
Mashhad
Postal code
91735
Phone
+98 513882950115
Fax
+98 51 3882 9500
Email
madania@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Dentistry School
Full name of responsible person
Dr Azam Madani
Position
prosthodontist
Other areas of specialty/work
Street address
School of Dentistry, Vakilabad Blvd
City
Mashhad
Postal code
91735
Phone
+98 513882950115
Fax
+98 51 3882 9500
Email
madania@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
dentistry school
Full name of responsible person
Dr azam Madani
Position
prosthodontist
Other areas of specialty/work
Street address
School of Dentistry, Vakilabad Blvd
City
Mashhad
Postal code
91735
Phone
+98 513882950115
Fax
+98 51 3882 9500
Email
madania@mums.ac.ir
Web page address
www.mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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