Protocol summary

Summary
About 20 to 30% of adults suffer from temporomandibular joint disorder, out of which 90% seek therapy for symptoms relating to temporomandibular joint. Non-surgical treatment is the first step in the treatment of patients with joint pain and dysfunction. Common therapeutic methods to reduce pain and dysfunction of temporomandibular joint are: drug therapy, laser therapy, physical therapy, etc. While previous studies have addressed the effects of drug therapy and laser therapy on patients with temporomandibular joint disorders, none of them have used Helium-Neon laser. Additionally, no comparison has been made between the effects of this method and drug therapy. Consequently, the aim of the present study is to compare the effects of laser and drug therapy in patients with temporomandibular joint disorders. This randomized control trial was carried out on a sample of 72 patients who met the inclusion criteria for the study. The patients were randomly divided into two groups of drug therapy and laser therapy. Inclusion criteria was patients within the age of 20 to 45 who had at least two of the following symptoms: 1.Dysfunction of masticatory muscles; 2.Restrictive jaw movements; 3.Clicking sound; and exclusion criteria included: 1. Any kind of systemic illness; 2.Any kind of supportive therapies like drug therapy and physical therapy; Evaluation of pain was done using Visual Analog Scale and Active Range Of Motion. Both methods were effective in the treatment of temporomandibular joint disorders; however, laser showed significant decrease in the recovery process.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412235565N3
Registration date: 2015-01-07, 1393/10/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-07, 1393/10/17
Registrant information
Name
Ali Peimani
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0008
Email address
a_peymani@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2014-04-19, 1393/01/30
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Control Trial of Comparing low level Helium-Neon laser and pharmacological therapy in pain relief of patients with temporomandibular disorders
Public title
Comparison of low level Helium-Neon laser and pharmacological therapy in patients with temporomandibular disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 20-45; Dysfunction of masticatory muscles; Restrictive jaw movements; Clicking sound; Sensitivity to palpation at Temporomandibular Joint. Exclusion criteria: Any kind of systemic illness; Any kind of supportive therapies like drug therapy and physical therapy; Age limits other than 20 to 45.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
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
Rafsanjan University of Medical Sciences
Street address
Emam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Postal code
Approval date
2014-04-15, 1393/01/26
Ethics committee reference number
93015

Health conditions studied

1

Description of health condition studied
temporomandibular disorder
ICD-10 code
k07.6
ICD-10 code description
Other enteropathic arthropathies

Primary outcomes

1

Description
Evaluation of the amount of pain
Timepoint
Immediately after treatment, 1 week, two week and 4 weeks after trearment
Method of measurement
visula analog scale

2

Description
Evaluation of Clicking sound
Timepoint
Immediately after treatment, 1 week, two week and 4 weeks after trearment
Method of measurement
palpation of patients ear and using sthetoscope

3

Description
Restrictive mouth movements
Timepoint
Immediately after treatment, 1 week, two week and 4 weeks after trearment
Method of measurement
Using a ruler

4

Description
Tenderness
Timepoint
Immediately after treatment, 1 week, two week and 4 weeks after trearment
Method of measurement
palpation of masseter and temporalis muscles and temporomandibular joint

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: using low power Helium-Neon laser in patients with Temporomandibular joint disorder
Category
Treatment - Other

2

Description
Control: Using the usual drug therapy to relieve the symptoms in patients with Temporomandibular joint disorder
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rafsanjan Dental School
Full name of responsible person
Dr Ali Peymani
Street address
West Mofatteh Blvd, Rafsanjan Dental School
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Peymani
Street address
Rafsanjan Dental School
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Peymani
Position
Assistant Professor
Other areas of specialty/work
Street address
Rafsanjan Dental School
City
Rafsanjan
Postal code
Phone
+98 34 3428 0030
Fax
Email
alipeimani2001@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Peymani
Position
Assistant Professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Rafsanjan Dental School
City
Rafsanjan
Postal code
Phone
+98 34 3428 0030
Fax
Email
alipeimani2001@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Sepideh Assar
Position
Post graduate student of Oral and Maxillofacial Pathology
Other areas of specialty/work
Street address
Shiraz Dental School
City
Shiraz
Postal code
Phone
+98 71 3623 1559
Fax
Email
sepideh1986@yahoo.com
Web page address

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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