This study aimed to assess the effect of low-level laser therapy on pain, swelling and maximum mouth opening in patients undergoing third molar surgery. Forty four patients were recruited at Dental School at Ahvaz Jundishapur University of Medical Sciences from March 2015 to January 2016. Twenty eight patients received low-level laser therapy and 16 patients received routine drug therapy including dexametazone, ibuprofen, amoxicillin and mouthwash. The laser was administrated into two manners including intraoral at two points of vestibular and lingual at the distance of 1 cm from surgery site and extraorally at the conjunction of masseter muscle immediately after surgery and repeated at 24 hours after surgery as well. The pain, swelling and MMO (maximum mouth opening) was compared between two groups at 24 hours and one week after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061228402N1
Registration date:2016-06-19, 1395/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Mehdi Khani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6504
Email address
khani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effects of low-level laser therapy after impacted lower third molar surgery
Public title
Effects of laser therapy on diminishing pain after impacted lower third molar surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: a range of age from 18 to 30 years old; the absence of systemic diseases; and impacted third molar with difficulty degree of III B (according to Winter’s classification and Gregory’s classification). Exclusion criteria: contraindications for laser therapy; teeth with pulp involvement; smoking; oral contraception; pregnancy; and breast feeding.
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Ethics comittee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences Ahvaz,Golestan Boulevard,
City
Ahvaz
Postal code
Approval date
2016-02-19, 1394/11/30
Ethics committee reference number
IR.AJUMS.REC.1394.560
Health conditions studied
1
Description of health condition studied
Impacted third molar surgery
ICD-10 code
K01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
Post-operative pain
Timepoint
24 hours after surgery and one week after surgery
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Post-operative swelling of face
Timepoint
24 hours after surgery and 1 week after surgery
Method of measurement
The distance between two specified points
Intervention groups
1
Description
Intervention group: The patients in intervention group received low-level laser therapy using diode laser (G-laser 25, Galbiati, Italy) with continuous length wave of 980 nm with hand piece of 600 µm. The laser energy was justified on 300 mW and was emitted for 180 seconds (60 seconds for each site). The laser was administrated into two manners including intraoral at two points of vestibular and lingual at the distance of 1 cm from surgery site and extraorally at the conjunction of masseter muscle immediately after surgery and repeated at 24 hours after surgery as well.
Category
Treatment - Devices
2
Description
Control group: patients received 1 gr amoxicillin orally per 12 hours up to 5 days and 1600 mg ibuprofen up to 2 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maxillofacial Operating Room of Imam Khomeini Hospital
Full name of responsible person
Mehdi Khani
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmalzadeh
Street address
Golestan Boulevared
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zeinab Shajirat
Position
Master of Sciences
Other areas of specialty/work
Street address
Fourth floor, Imam Khomeini Hospital, Azadegan Boulevard, Research Deputy of Imam Khomeini Hospital Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3221 6504
Fax
Email
zeinab.shajirat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdi Khani
Position
Resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
Maxillofacial operating room, Imam Khomeini Hospital, Azadegan Boulevard, Research Deputy of Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3221 6504
Fax
Email
dr.khani6282@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zeinab Shajirat
Position
Master of Science (MSc)
Other areas of specialty/work
Street address
Fourth floor, Research Deputy, Imam Khomeini Hospital, Azadegan Boulevard Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3221 6104
Fax
Email
zeinab.shajirat@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)