Effect of scaling and root surface correction with and without laser on gingival crevicular fluid cytokine levels in patients with chronic periodontitis: a double-blind randomized clinical trial
To assess the effect of scaling and root surface correction with and without laser on gingival crevicular fluid cytokine levels in patients with chronic periodontitis
Design
This is a double-blind randomized clinical trial, in which 15 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with chronic periodontitis referring to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 to 65 years,
Chronic periodontitis,
Packet depth of 4 to 7 mm without destruction of angular bone,
Exclusion criteria:
Pregnancy or breastfeeding,
Generalized moderate to severe chronic periodontitis,
Chronic liver or renal diseases or diabetes,
Using tobacco
Intervention groups
Intervention group:
On one side of the patient, scaling and root surface correction by a piezoelectric scaling machine with a sharp pen plus laser Cr;YSGG Er with a head of RFTP5 with 1.5 W and 30 hz with angle less than 15 degree parallel to the tooth axis for 10 minutes
Control group:
On the other side of the patient, scaling and root surface correction by a piezoelectric scaling machine with a sharp pen
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-13, 1399/11/25
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of scaling and root surface correction with and without laser on gingival crevicular fluid cytokine levels in patients with chronic periodontitis: a double-blind randomized clinical trial
Public title
Effect of scaling and root surface correction with and without laser on gingival crevicular fluid cytokine levels in patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 65 years,
Chronic periodontitis,
Packet depth of 4 to 7 mm without destruction of angular bone,
Exclusion criteria:
Pregnancy or breastfeeding,
Generalized moderate to severe chronic periodontitis,
Chronic liver or renal diseases or diabetes,
Using tobacco
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring to every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The use of the laser as the main intervention on one side of the patient's mouth and not using it on the opposite side will be done simultaneously thus the patient will not be aware which part of the mouth will be affected by the laser. The physician who will examine the patients will not be aware of the intervention. .Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-12-19, 1399/09/29
Ethics committee reference number
IR.UMSHA.REC.1399.790
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Gingival crevicular fluid cytokine IL-1B levels
Timepoint
Before the intervention and 3 months later
Method of measurement
Using Elisa test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On one side of the patient, scaling and root surface correction by a piezoelectric scaling machine with a sharp pen plus laser Cr;YSGG Er with a head of RFTP5 with 1.5 W and 30 hz with angle less than 15 degree parallel to the tooth axis for 10 minutes
Category
Treatment - Other
2
Description
Control group: On the other side of the patient, scaling and root surface correction by a piezoelectric scaling machine with a sharp pen
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Sahar Hemmatian
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sahar.hemmatian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Hemmatian
Position
Resident of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sahar.hemmatian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Janet Moradi
Position
Periodontist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Janet_haghgoo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available