Comparison of the Effectiveness of Red and Infrared Low level Laser Therapy for Post Operative Pain Control,Swelling and Trismus in Patients with Impacted Mandibular Third Molar
Evaluating the effectiveness of red and infrared low level laser therapy on pain control, swelling and trismus after impacted lower 3rd molar removal and comparing the amount of analgesic used in each group.
Design
Randomized double-blinded clinical trial with 3 parallel group design of 30 patients.Randomization is achieved through www.randomization.org website in 3 groups of 10 from number 1 to 30.
Settings and conduct
The study will be conducted in the department of Maxillofacial Surgery, Tabriz Faculty of Dentistry.In the first group red laser is applied extraorally on 2 occasions. In the second and the control group respectively infrared and placebo will be applied as described in the first group.Switching on /off of the laser therapy device is controlled by the responsible nurse and the patient and the researcher are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients(aged 18 to 35) with impacted lower third molar without any systemic disease.
Exclusion criteria: patients with distoangular or vertical impacted lower 3rd molar, soft tissue impaction, allergy to local anesthetics, systemic disease, local infection and pregnancy.
Intervention groups
In the first group red laser is applied extraorally on 2 occasions, before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation.
In the second group infra red laser is applied extraorally on 2 occasions, once before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation.
Placebo laser is applied extraorally on 2 occasions, once before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation.
Main outcome variables
Variables include the severity of pain, swelling, trismus and the number of pain relief tablets taken.
General information
Reason for update
Acronym
LLLT
IRCT registration information
IRCT registration number:IRCT20110420006239N2
Registration date:2019-06-07, 1398/03/17
Registration timing:registered_while_recruiting
Last update:2019-06-07, 1398/03/17
Update count:0
Registration date
2019-06-07, 1398/03/17
Registrant information
Name
javad yazdani
Name of organization / entity
faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41133559659
Email address
yazdanij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Red and Infrared Low level Laser Therapy for Post Operative Pain Control,Swelling and Trismus in Patients with Impacted Mandibular Third Molar
Public title
Evaluating the Effectiveness of Red and Infrared Low Level laser Therapy on Pain Control after Removal of Impacted Wisdom Teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to the dental clinic who require the removal of impacted lower 3rd molar
Patients who have impacted lower 3rd molar with grade lllB or IIIC surgical difficulty according to Pell-Gregory classification
Patients who have mesioangular impacted lower 3rd molar
Patients without any systemic disease
Exclusion criteria:
Patients with distoangular or vertical impacted lower 3rd molar
Soft tissue impaction of the lower 3rd molar
Hypersensitivity to local anesthetics
Patients with systemic disease
Local infection
Blood dyscrasias
Patients with a history of gastric ulcer or patients who are currently suffering from a gastric ulcer
Cardiovascular condition
Pregnancy
Lactation
Patients who have used analgesic or anti inflammatory drugs 24 hours prior surgery
Surgical procedures taking longer than 20 minutes
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is achieved through www.randomization.org website in 3 groups of 10 from number 1 to 30.
Blinding (investigator's opinion)
Double blinded
Blinding description
Switching on /off of the laser therapy device is controlled by the responsible nurse and the patient and the researcher are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Dentistry faculty of Tabriz, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1017
Health conditions studied
1
Description of health condition studied
Trismus
ICD-10 code
R25.2
ICD-10 code description
Cramp and spasm
2
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
3
Description of health condition studied
Swelling
ICD-10 code
R60
ICD-10 code description
Edema, not elsewhere classified
4
Description of health condition studied
Total analgesic drug consumption
ICD-10 code
Y45.3
ICD-10 code description
Other nonsteroidal anti-inflammatory drugs [NSAID]
Primary outcomes
1
Description
Pain
Timepoint
Day 2 post-operation, day 7 post-operation
Method of measurement
Visual analog scale (asking from patient, scoring from 1 to 10)
2
Description
Swelling
Timepoint
Pre-operation, day 2 post-operation, day 7 post-operation
Pre-operation, day 2 post-operation, day 7 post-operation
Method of measurement
Measuring the maximum space between central incisors of maxilla and mandible( in millimeter)
Secondary outcomes
1
Description
Number of pain relief tablets taken
Timepoint
Day 2 post-operation, day 7 post-operation
Method of measurement
Asking the patient
Intervention groups
1
Description
Intervention group:In first group red laser(with the wavelength of 660 nm and the power of 6 joules per square centimeter)is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Irradiation will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch). The laser will be applied for 7 minutes at each point.
Category
Treatment - Devices
2
Description
Intervention group: In the second group infra red laser(with the wavelength of 890 nm and the power of 6 joules per square centimeter) is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Irradiation will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch).The laser will be applied for 5 minutes at each point.
Category
Treatment - Devices
3
Description
Control group: Placebo laser(off laser) is applied extraorally on 2 occasions, once 30 minutes before the impacted lower 3rd molar surgery and the other one is performed on the second day after operation. Placebo laser therapy will be performed by positioning the laser probe in contact with the skin on four points of the masseter muscle: 1 –, lower region (near the mandibular insertion); 2 –, lower middle region; 3 –, upper middle region; and 4 –, upper region (near the insertion of the zygomatic arch).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Javad Yazdani
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Yazdanij@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ablolqasem Jouyban
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5965
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Javad Yazdani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 6965
Email
Yazdanij@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Yazdani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty of Tabriz, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5965
Email
Yazdanij@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Yazdani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 6965
Email
Yazdanij@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available