Comparison of the effect of low power Diode laser therapy and placebo on the amount of Interleukin 1 beta in gingival crevicular fluid after placement separators in orthodontic patients
The aim of the present study is to evaluate the effect of low level laser therapy on periodontal inflammation caused by elastomeric separators. This study is designed to be a single blind, split mouth, randomized clinical trial. Thirty 18-30 year-old orthodontic patients who do not have periodontal disease and are not under antibiotic or corticosteroid therapy are selected. Ginigival status (gingival index and bleeding point index) of maxillary first molars are recorded and gingival crevicular fluid is gathered. Then, elastomeric separators are placed in mesial and distal contacts of both maxillary first molars. One molar is randomly assigned to test group and is irradiated with 980 nanometer low level laser on buccal and lingual surfaces. The contralateral molar is assigned to control group and is pretended to be irradiated with the aforementioned laser while the laser is off (placebo). One week later, the gingival status (gingival index and bleeding point index) is assessed and gingival crevicular fluid is gathered. The amount of Interleukin 1-beta in the gingival crevicular fluid is evaluated by ELISA test. Finally, the changes in the three variables are detected by statistical analysis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011620523N2
Registration date:2017-02-25, 1395/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-25, 1395/12/07
Registrant information
Name
Sepideh Soheilifar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 2508
Email address
sepidehsoheilifar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-19, 1396/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low power Diode laser therapy and placebo on the amount of Interleukin 1 beta in gingival crevicular fluid after placement separators in orthodontic patients
Public title
The effect of laser therapy on gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Signing informed consent; Absence of active periodontal disease (probing depth less than 4 mm and lack of bleeding on probing in upper first molars); Absence of systemic disease.
Exclusion criteria: Presence of coagulation disease; Presence of acute or chronic disease (Based on patient chart); Presence of auto-immune disease; Patients under immune-suppressive therapy or radiotherapy; Patients who consume antibiotics; Patients who consume corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDS); Pregnant women.
8. Patients under periodontal treatment or prolonged consumption of chlorhexidine
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comitee of Hamedan University of Medical Sciences
Street address
Shahid Fahmide street, Hamedan University of Medical Sciences
City
Hamedan
Postal code
65178-38677
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.UMSHA.REC.1395.461
Health conditions studied
1
Description of health condition studied
Gingival inflammation
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Amount of interleukin 1 beta in gingival crevicular fluid
Timepoint
Before placement of separator and 1 week later
Method of measurement
ELISA on gingival crevicular fluid
Secondary outcomes
1
Description
Bleeding point index
Timepoint
Before placement of separator and 1 week later
Method of measurement
Occurence of bleeding during the movement of periodontal probe in gingival sulcus
2
Description
Gingival index
Timepoint
Before placement of separator and 1 week later
Method of measurement
Observation
Intervention groups
1
Description
Intervention 1: Irradiation of Diode laser with 980 nanometer wavelength and 1.5 Watts power with pulse irradiation with pulse length of 1 millisecond and pulse distance of 1 millisecond on buccal and lingual surface of maxillary first molar
Category
Treatment - Other
2
Description
Irradiation of off laser with the same movement on buccal and lingual surface of maxillary first molar
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Hamedan University of Medical Sciences
Full name of responsible person
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Said Bashirian
Street address
Shahid Fahmide street, Hamedan University of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sepideh Soheilifar
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Fahmide street, Hamedan University of Medical Sciences, Dental Faculty
City
Hamedan
Postal code
Phone
+98 81 3822 3750
Fax
Email
se.soheilifar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Soheilifar
Position
periodontics specialist- assistant professor
Other areas of specialty/work
Street address
Shahid Fahmide street, Hamedan University of Medical Sciences, Dental Faculty
City
Hamedan
Postal code
Phone
+98 81 3822 3750
Fax
Email
sara_soheilifar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sepideh Soheilifar
Position
Orthodontics Specialist- Assistant Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
se.soheilifar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)