The purpose of this study is to evaluate the effectiveness of low level Laser therapy (diode) on Postoperative Pain Following undisplaced Flap Surgery. This study is a randomized clinical trial with Split mouth design. 30 patients with bilateral periodontal pockets between 5 and 7 mm with undisplaced flap surgery indication will be selected. inclusion criteria are healthy patients with no systemic disease and plaque index >=10%.smokers and patients with long term antibiotic or steroidal therapy were excluded from study.all surgeries are performed by one surgeon with one month interval.
During periodontal flap surgery in the test site diode laser 940 nm with a power of 0.5W for 112 seconds will be irradiate to all surface of the flap, the exposed bone and exposed root surfaces. .In control group laser irradiation done by off power mode.One non steroidal anti inflammatory medication (Gelofen 400mg)was prescribed immediately post surgery and after that patients were asked to take capsule whenever they feel pain and record number of capsule at the end of each day. Patients record postoperative pain daily at night time for one week using a visual analogue scale( 0 to 10).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101724573N1
Registration date:2016-02-22, 1394/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-22, 1394/12/03
Registrant information
Name
Mohadeseh Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8351
Email address
mheidari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of low level Laser therapy (diode) on Postoperative Pain Following undisplaced Flap Surgery
Public title
effect of low level laser therapy on Postoperative Pain Following gingival Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: patients with 5 to 7 mm periodontal pockets in same teeth in two quadrant of jaw(needed to treat with undisplaced flap)
exclusion criteria:systemic disease, smokers, pregnant woman, long term antibiotic or steroid therapy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
mazandaran university of medical science
Street address
mazandaran university of medical science, emam square, sari,IRAN
City
sari
Postal code
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
IR.MAZUMS.REC.94-1655
Health conditions studied
1
Description of health condition studied
periodontits
ICD-10 code
k05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Pain
Timepoint
every night for a week
Method of measurement
Based on the visual analogue scale of the questionnaire and the number of analgesic consumption
Secondary outcomes
empty
Intervention groups
1
Description
Test group: diode laser( wave length: 940 nm, power: 0.5 W, time of irradiation: 112s, distance: 3mm) will be applying during the surgery to all of flap surface, internal and external surface, exposed bone and exposed root structures.
Category
Other
2
Description
control group:after surgery laser irradiated by off power mode.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Facultyl of Dentistry, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Maziar Khatami, Assistant Professor, Department of Periodontics
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, IRAN
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Farhad Sobouti, Research Assistant
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, IRAN
City
sari
Grant name
**/***
Grant code / Reference number
***
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Facultyl of Dentistry, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohadeseh Heidari
Position
Periodontologist, Assistant Professor, Department of Periodontics
Other areas of specialty/work
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, IRAN
City
sari
Postal code
4816795477
Phone
+98 11 3325 4135
Fax
Email
mheidari@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohadeseh Heidari
Position
periodontologist
Other areas of specialty/work
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, IRAN
City
sari
Postal code
4816895477
Phone
+98 11 3325 4135
Fax
Email
mheidari@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)