This study has been used to evaluate the effects of Low-Level Laser Therapy (LLLT) on the post-surgical complications after third molar removal was done on 50 patients who candidate for surgical removal of impacted lower third molar in soft tissue. Patients randomly divided in two groups each with 25 patients. One group received the LLLT with an 810 nm wave length applied intra orally for 10 seconds after extraction procedure. Laser treatment was simulated in control group. Postoperative complications then were evaluated on 1, 3 and 7 days follow the after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061818142N1
Registration date:2014-07-19, 1393/04/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-19, 1393/04/28
Registrant information
Name
Firouz Amani
Name of organization / entity
Ardabil Univesity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 3777
Email address
f.amani@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil Univesity of Medical Sciences
Expected recruitment start date
2012-08-21, 1391/05/31
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Low-Level Laser Therapy on the post-surgical complications of third molar removal in referred patients to faculty of dentistry clinic
Public title
Effect of Low-Level Laser Therapy in the control of post-surgical complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with impacted wisdom teeth in soft tissue
Exclusion criteria: Systemic Disease such as diabetic, Heart failure and pulmonary, CVA, Immunological disorders; Current consumption of cigarettes; Patients who had a wisdom tooth infection around the resort and need for another therapies; Patients with eating disorders; patients who did not accept the Laser; peoples who did not comply the drug protocol after surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ardabil University of Medical Science
Street address
Daneshghah st, Ardabil University of Medical Science, Ardabil
City
Ardabil
Postal code
56197
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
Arums.REC.1392.17
Health conditions studied
1
Description of health condition studied
Wisdam impacted teeth
ICD-10 code
Embedded a
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Recovery
Timepoint
Baseline, Third Day and The Seventh Day
Method of measurement
clinical
2
Description
Pain
Timepoint
Baseline, Third Day and The Seventh Day
Method of measurement
VAS
3
Description
Edema
Timepoint
Baseline, Third Day and The Seventh Day
Method of measurement
In Clinical
4
Description
Trismus
Timepoint
Baseline, Third Day and The Seventh Day
Method of measurement
The mouth opening
Secondary outcomes
empty
Intervention groups
1
Description
Laser with 810 mm wave lenght , 15 J energy and 0.5 W power in laser group
Category
Treatment - Surgery
2
Description
Laser pretense in control group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Ardabil University of Medical Science
Full name of responsible person
Abolfazl Bagheri
Street address
Daneshghah st, faculty of dentistry, Ardabil University of Medical Science, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil Univesity of Medical Science
Full name of responsible person
Dr. Hadi Piri
Street address
Daneshghah st, Faculty of dentistry, Ardabil Univesity of Medical Science, Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil Univesity of Medical Science
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
Dr.Abolfazl bagheri
Position
Assistant Prof
Other areas of specialty/work
Street address
Daneshghah st, Faculty of dentistry, Ardabil University of Medical Science, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1551 0054
Fax
+98 45 1551 0054
Email
a.bagheri@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of dentistry, Ardabil University of Medical Science
Full name of responsible person
Abolfazl Bagheri
Position
Assistant Prof
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
56197
Phone
+98 45 1551 0054
Fax
+98 45 1551 0054
Email
a.bagheri@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Science
Full name of responsible person
Firouz Amani
Position
Assistant Prof
Other areas of specialty/work
Street address
Daneshghah st, faculty of medicine, Ardabil University of Medical Science, Ardabil
City
Ardabil
Postal code
0098451
Phone
+98 45 1551 3777
Fax
+98 45 1551 0057
Email
f.amani@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)