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Evaluation of therapeutic effect and placebo effect of low level laser therapy in temporomandibular disorders

Protocol summary

Study aim
evaluation of therapeutic and placebo effects of low level leaser therapy for pain relief due to temporomandibular joint disorders
Design
randomized double blind, parallel clinical trial, 3 groups , whit control group, 15 participant in each groups (total :45), enrolled between September 2019 and September 2020
Settings and conduct
this study take place in Department of Oral Medicine and Orofacial Pain, Kerman School of Dentistry by pain specialist. Diagnostic Criteria for TMD (DC/TMD) Axis I use for diagnosis. patients and doctors will not aware of patients' tretment groups and just low level leaser device operator will be informed.
Participants/Inclusion and exclusion criteria
inclusion criteria: Myofascial pain ( muscle trigger point), TMJ tenderness, limitation of mouth opening due to muscle pain or TMJ inflammation, ability of reading and writing to answer questionnaires, patient cooperation and compliance, men and women 15-60 years old exclusion criteria: using corticosteroids and narcotics, mixed dentition, developmental deformity, current orthodontic, orthopedic appliance or splint therapy,dental carries which replicated patient's pain, partial or complete denture, pregnancy and breast feeding, history of pathological lesions in temporomandibular regions, history of chemotherapy and radiotherapy of head and neck, inability of answer to questionnaires, periodontal diseases, rheumatologic diseases, Degenerative Joint Disease TMJ
Intervention groups
group control: no intervention, patients fallow standard treatment protocol without Encounter by low level leaser therapy (LLLT). intervention group 1: use active LLLT for patients + standard treatment protocol intervention group 2: use inactive LLLT for patients + standard treatment protocol
Main outcome variables
Visual Analogue Scale (VAS), Total trigger point score, Maximum mouth opening, Joint sounds

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180602039951N1
Registration date: 2019-09-15, 1398/06/24
Registration timing: registered_while_recruiting

Last update: 2019-09-15, 1398/06/24
Update count: 0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
sahar Mafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8074
Email address
s.mafi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect and placebo effect of low level laser therapy in temporomandibular disorders
Public title
Evaluation of therapeutic effect and placebo effect of low level laser therapy in temporomandibular disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
acute and chronic myofascial pain ( muscle trigger point) TMJ tenderness without degenerative diseases limitation of mouth opening due to muscle pain or TMJ inflammation ability of reading and writing to answer questionnaires patient cooperation and compliance men and women between 15-60 years old
Exclusion criteria:
using NSAID, corticosteroids,anti-convulsant, anti-psychotic, anti-depressant and narcotics mixed dentition developmental head and face deformity current orthodontic treatment, orthopedic appliance or splint therapy dental carries which replicated patient's pain in head and face partial or complete denture pregnancy and breast feeding history of pathological lesions in temporomandibular regions history of chemotherapy and radiotherapy of head and neck inability of answer to questionnaires periodontal diseases rheumatologic diseases Degenerative Joint Disease TMJ
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
randomization will be done by computer software, patients will be divided to 3 groups, receptionist will extract patient's group and pass it to operator in sealed envelop. patients and doctors that evaluate treatment result will not be informed of patient's groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients: Blind interviewer: Blind therapist: Blind low level leaser machine operator: informed receptionist will extract patient's group and pass it to operator in sealed envelop. patients and their doctors will not informed. patients are blindfolded and beeping sound of machine is on for both groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Kerman university of medical science
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.KMU.REC.1396.2420

Health conditions studied

1

Description of health condition studied
temporomandibular disorders
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders

Primary outcomes

1

Description
effect of low level leaser therapy on total trigger point score
Timepoint
Total trigger point score before intervention, and 1, 2, 3,4,5,weeks during intervention and one month after final intervention will be recorded
Method of measurement
head and neck muscles examination

2

Description
effect of low level leaser therapy on jaw sounds
Timepoint
before intervention, and 1, 2, 3,4,5,weeks during intervention
Method of measurement
Stethoscope

3

Description
effect of low level leaser therapy on jaw movement
Timepoint
before intervention, and 1, 2, 3,4,5,weeks during intervention
Method of measurement
ruler

4

Description
effect of low level leaser therapy on visual analog scale
Timepoint
before intervention, and 1, 2, 3,4,5,weeks during intervention
Method of measurement
visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: gallium–aluminum–arsenide, 808nm ، 300 mw، 3J/cm2 ، 10S 10 session ( twice a week for 5 weeks), 4 points around temporomandibular joint and every muscle trigger point in head and neck.
Category
Treatment - Devices

2

Description
Intervention group: Intervention group 2 : using the same device that used in intervention group 1. Intervention in this group will be same as intervention group except that the device will be in active.
Category
Placebo

3

Description
Control group: patients in this group will not face low level leaser therapy and will follow standard treatment protocol.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
orofacial Pain Department of Dentistry School of Kerman
Full name of responsible person
Goli Chamani
Street address
Shafa Boulevard, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
s.mafi@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental School of Kerman University of Medical science
Full name of responsible person
Molouk Torabi
Street address
Dental School of Kerman University of Medical science, Shafa Boulevard, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
m_torabi@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental School of Kerman University of Medical science
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
Kerman University of Medical Sciences
Full name of responsible person
Sahar Mafi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shafa Boulevard, Kerman, Kerman Province
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
s.mafi@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahar Mafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Jomhouri Boulevard, Shafa Boulevard, Kerman Province, Kerman,
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Fax
Email
s.mafi@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahar Mafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Jomhouri Boulevard, Shafa Boulevard, Kerman Province, Kerman,
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Fax
Email
s.mafi@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD, IPD collected for the primary outcome measure only
When the data will become available and for how long
6 months after publication
To whom data/document is available
for people working in academic institutions or people working in businesses
Under which criteria data/document could be used
people working in academic institutions
From where data/document is obtainable
s.mafi@kmu.ac.ir Dr.Sahar Mafi
What processes are involved for a request to access data/document
requests containing how the data will be used must be applied via Email. Citation in future publication is mandatory. Data will be sent within 3 months.
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