Protocol summary

Summary
Maxillofacial disorders are leading to pain and functional limitations in head and face . The purpose of this paper is to investigate the effect of low level laser therapy in the treatment of maxillofacial disorders. This is a single-blind trial of 142 patients with maxillofacial disorders that can be done in 2 groups of 71 subjects were randomized to the control and experimental groups. patients with adverse conditions are excluded from the study. Background information obtained through the questionnaire , and the amount of pain on the visual pain scale. Experimental and control groups treated for 12 sessions (3 times a week for 15 minutes each time) under irradiation with a mean score of 2.5 and zero joules per square centimeter and applying infrared radiation Will be evaluated pain variable .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014120919135N2
Registration date: 2015-01-03, 1393/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Ali Ghanjal
Name of organization / entity
Baqiyatallah University
Country
Iran (Islamic Republic of)
Phone
+98 88057022
Email address
ghanjal@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiyatallah University
Expected recruitment start date
2010-11-05, 1389/08/14
Expected recruitment end date
2014-11-05, 1393/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low level laser therapy in improving patients with maxillofacial disorders
Public title
The Effect of low power laser in maxillofacial disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : a maxillofacial disorders. Exclusion criteria :The adverse conditions; certain other medical procedures.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 142
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bghiyatallah University
Street address
Shaykh Bahaee Street
City
Tehran
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
1189

Health conditions studied

1

Description of health condition studied
Maxillofacial disorders
ICD-10 code
K07.5
ICD-10 code description
K07.6 Temporomandibular joint disorders . K07.8 Other dentofacial anomalies. K08 Other disorders of teeth and supporting structures . K07.9 Dentofacial anomaly, unspecified

Primary outcomes

1

Description
Pain
Timepoint
Before and after of research
Method of measurement
Visual Analog Scale.

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group will be for 12 sessions ( 3 times a week for 15 minutes each time ) under irradiation with a mean score of 2.5 and zero joules per square centimeter and applying infrared radiation .
Category
Rehabilitation

2

Description
The method for the control group will be similar to the experimental group ( The device is switched on , and the zero output ) .
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghiyatallah University
Full name of responsible person
Ali Ghanjal
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baghiyatallah University
Full name of responsible person
Ali Ghanjal
Street address
Shaykh Bahaee Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baghiyatallah University
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
Baghiyatallah University
Full name of responsible person
Ali Ghanjal
Position
Assistant Profesor
Other areas of specialty/work
Street address
Shaykh Bahaee Street
City
Tehran
Postal code
Phone
+98 21 8805 7022
Fax
Email
ghanjala@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University
Full name of responsible person
Ali Ghanjal
Position
Assistant Professor
Other areas of specialty/work
Street address
Mulla sadra Street
City
Tehran
Postal code
Phone
+98 21 8805 7022
Fax
Email
ghanjala@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah University
Full name of responsible person
Ali Ghanjal
Position
Assistant Professor
Other areas of specialty/work
Street address
Mulla sadra Street
City
Tehran
Postal code
Phone
+98 21 8805 7022
Fax
Email
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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