Investigating the effects of LLLT in pain reduction and the improvement of the healing process in patients with Alveolar Osteitis in comparison to the conventional methods.
Non-blind randomized clinical trial,
Single-center, control group with conventional therapy.
The study population of 16 patients,
Inclusion criteria: dry socket without taking any previous treatment.
Criteria for diagnosis of dry socket is the pain after tooth extraction in the extraction area and around it which is growing in next three days and is along with the full or partial breakdown of clots.
Exclusion criteria: history of radiation therapy in the past. Use of antibiotics, pregnancy and breast feeding. Also patients who smoke, patients who are in the menstrual cycle and take oral contraceptive medicines.in control group, the extraction area is wash out with sterile Salin solution and cover with Zinc Oxide Eugenol pack. This treatment is repeated up to three sessions and every other day.
In the intervention group, the patients are irradiated with a low level laser in a "continuous Mode" with a wavelength of 808 nm and a power of 100 mW. Laser is radiated for 60 seconds with a distance of approximately 1 cm from the wound and in a perpendicular way. This treatment is also repeated up to three sessions and every other day. pain measurement: before and after the treatment sessions with VAS(Visual Analogue Scale)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051722299N1
Registration date:2015-06-27, 1394/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-27, 1394/04/06
Registrant information
Name
Elaheh Aghababarangraz
Name of organization / entity
Faculty of Dentistry at Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5950
Email address
e-rangraz@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of low level laser therapy on pain in patients with dry socket in comparison to the conventional method
Public title
Investigating the effect of laser in the treatment of dry socket
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria is the previous diagnosis of dry socket without taking any previous treatment. The criteria for the diagnosis of dry socket is the pain after tooth extraction in the extraction area and around it which is growing in next three days and is along with the full or partial breakdown of clots. Items that are excluded from the study include the past history of radiation therapy, any medical problem that may affect the treatment of dry socket (such as the pathological state of bone, vascular and hematologic diseases and diabetes mellitus),and the use of antibiotics, pregnancy and breast-feeding. Also, patients who smoke, who are in the menstrual cycle and those who take oral contraceptive medicines.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Department of Educational Research at Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, North Kargar St.
City
Tehran
Postal code
14399-55991
Approval date
2015-06-16, 1394/03/26
Ethics committee reference number
IR.TUMS.REC.1394.56
Health conditions studied
1
Description of health condition studied
dry socket
ICD-10 code
K10.3
ICD-10 code description
Alveolar osteitis
Primary outcomes
1
Description
pain
Timepoint
Before the treatment, before and after each treatment session, which takes place every other day.
Method of measurement
VAS (Visual Analogue Scale)
Secondary outcomes
1
Description
The number of analgesic tablets
Timepoint
Before the treatment and after each treatment session, which takes place every other day
Method of measurement
The number of tablets consumed is calculated according to the questionnaire filled out by the patient.
Intervention groups
1
Description
In the intervention group, the patients are irradiated with a low level laser in a "continuous Mode" with a wavelength of 808 nm and a power of 100 mW. Laser is radiated for 60 seconds with a distance of approximately 1 cm from the wound and in a perpendicular way. This treatment is also repeated up to three sessions and every other day.
Category
Treatment - Devices
2
Description
In control group, the extraction area is wash out with sterile Salin solution and cover with Zinc Oxide Eugenol pack. This treatment is repeated up to three sessions and every other day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry at Tehran University of Medical Sciences
Full name of responsible person
Elaheh Aghababarangraz
Street address
Faculty of Dentistry at Tehran University of Medical Sciences , before the entrance of Hakim highway , North Karegar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Faculty of Dentistry at Tehran University of Medical Sciences
Full name of responsible person
Dr. Amirreza Rokn
Street address
Faculty of Dentistry at Tehran University of Medical Sciences , before the entrance of Hakim highway , North Karegar St.
City
Tehran
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 Faculty of Dentistry at 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 at Tehran University of Medical Sciences
Full name of responsible person
Elaheh Aghababarangraz
Position
Student
Other areas of specialty/work
Street address
Faculty of Dentistry at Tehran University of Medical Sciences , before the entrance of Hakim highway , North Karegar St.
City
Tehran
Postal code
14399-55991
Phone
+98 21 8801 5950
Fax
+98 21 8801 5951
Email
E-rangraz@student.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry at Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Parhiz
Position
assistant professor
Other areas of specialty/work
Street address
Faculty of Dentistry at Tehran University of Medical Sciences , before the entrance of Hakim highway , North Karegar St.
City
Tehran
Postal code
14399-55991
Phone
+98 21 8801 5950
Fax
+98 21 8801 5951
Email
Alirezaparhiz@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry at Tehran University of Medical Sciences
Full name of responsible person
Elaheh Aghababarangraz
Position
Student
Other areas of specialty/work
Street address
Faculty of Dentistry at Tehran University of Medical Sciences , before the entrance of Hakim highway , North Karegar St.
City
Tehran
Postal code
14399-55991
Phone
+98 21 8801 5950
Fax
+98 21 8801 5951
Email
E-rangraz@student.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)