Objective: A randomized, double-blind comparative study was undertaken to assess the efficacy of low level laser therapy in the reduction of postoperative pain and trismus in patients undergoing the extraction of impacted mandibular third molar teeth. This study included 40 patients of both sexes; they were randomly selected from patients undergoing surgical extraction of impacted LTMs of the same position in the jaw and had similar status with regard to the difficulty of surgical removal. Patients were randomly allocated to one of two groups: LLLT, or placebo. Subsequently to suturing, patients in LLLT group had their operation side, treated with an 810 nm, infrared laser irradiation, intraorally 1 cm from the target tissue 10 min after surgery. The other group just received routine recommendation. In the placebo group the handpiece was inserted into the operative side intraorally but laser was not activated. Inter incisal opening and pain were evaluated on second and 7th postoperative days. Patients were instructed to evaluate their postoperative pain on 2 and 7 days after surgery by means of visual analogue scale (VAS). Student’s t-test or U-Mann Whitney used to analyze the data.
General information
Acronym
LPL, LTM
IRCT registration information
IRCT registration number:IRCT138904134278N2
Registration date:2010-10-17, 1389/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-17, 1389/07/25
Registrant information
Name
Mehrnoush Momeni
Name of organization / entity
Faculty of Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3620
Email address
momeni_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Dean for research, Faculty of Dentistry, Tehran University of Medical Sciences.
Expected recruitment start date
2009-05-01, 1388/02/11
Expected recruitment end date
2010-04-05, 1389/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low power Laser on reduction pain and trismus after third Molar.
Public title
The effect of low power Laser on pain and trismus after third Molar surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with unilateral impacted lower Third molar and no systemic problem and also not used any analgesic, antibiotic, corticosteroid, and sedative drug at least for fifteen days before surgery were registered at the surgery department of faculty of dentistry of Tehran university of Medical science. Exclusion criteria: Low compliant patients Not attending at the expected time of measurement.
Age
From 19 years old to 29 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran university of medical sciences, vice chancellor for research
Street address
Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-05-10, 1389/02/20
Ethics committee reference number
88-03-70-8972
Health conditions studied
1
Description of health condition studied
Trismus
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Pain
Timepoint
Before surgery-48 h after surgery-7 days after surgery
Method of measurement
Using VAS
Secondary outcomes
1
Description
Trismus
Timepoint
Before surgery-48 h after surgery-7 days after surgery
Method of measurement
Using a rule that measure intra incisal.mm
Intervention groups
1
Description
Intervention group: patients in LLLT group had their operation side, treated with an 810 nm, infrared laser irradiation, intraorally 1 cm from the target tissue 10 min after surgery.
Category
Treatment - Devices
2
Description
Control group: Received routine recommendation. In the placebo group the handpiece was inserted into the operative side intraorally but laser was not activated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr Mehrnoush Momeni
Street address
Ghods avenue-Enghelab square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr.Fotoohi
Street address
Ghods Ave-Enghelab square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Dentistry, Tehran 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
Faculty of dentistry
Full name of responsible person
Sheida Kordi
Position
Administrator-student of profissional doctor
Other areas of specialty/work
Street address
Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8474 1728
Fax
Email
sheida_kordi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of dentistry
Full name of responsible person
Mehrnoush Momeni
Position
Assistant Professor/oral and maxillofacial surgeon
Other areas of specialty/work
Street address
Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2201 3541
Fax
Email
Mmomeni_m@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of dentistry
Full name of responsible person
Sheida Kordi
Position
Student
Other areas of specialty/work
Street address
Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8474 1728
Fax
Email
sheida_kordi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)