the effect of adjunctive2 wave-lenght laser therapy with scaling and root planning(SRP) on gingival crevicular fluid(GCF) IL-10 level in chronic periodontitis
periodontics department, Islamic Azad university of medical science
split-mouth design on 16 patients with 6 months follow up
single blind study
Participants/Inclusion and exclusion criteria
patients with moderate to severe chronic periodontitis, No systemic disease, having at least 16 teeth, no use of drugs (anti-biotic, corticostroid, immuo-suppressive), no history of periodontal treatment during last 6 months, no pregnancy and/or breast-feeding
Intervention groups
test group1: 1 quadrants will be treated by diode laser 940nm following SRP(scaling and root planing).
test group2: 1 quadrants will be treated by Er,Cr:YSGG 2780nm following SRP(scaling and root planing).
control group: the third quadrant will recieve only SRP treatment
Main outcome variables
Interleukin-10
clinical attachment level (CAL)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140318017053N11
Registration date:2019-06-19, 1398/03/29
Registration timing:retrospective
Last update:2019-06-19, 1398/03/29
Update count:0
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
Ferena Sayar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
f_sayar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficiency of 940 nm diode laser and Er,Cr:YSGG 2780 nm following SRP on IL-10 level in GCF of patient with chronic periodontitis
Public title
The effect of laser therapy on IL-10 level during periodontal treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
systemic health
Having 16 teeth or more
patient with moderate to severe chronic periodontitis
Exclusion criteria:
smoking
pregnancy
breast-feeding
use of drugs (corticostroid, anti-biotic, immuno-suppressive)
periodontal therapy during the last 6 months.
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
16
More than 1 sample in each individual
Number of samples in each individual:
3
collecting GCF
Randomization (investigator's opinion)
Randomized
Randomization description
randomization by computer generated randomization list (microsoft excel 2010)
Blinding (investigator's opinion)
Single blinded
Blinding description
investigator will not aware of the control and test sites, he only records clinical data.
Placebo
Not used
Assignment
Parallel
Other design features
split-mouth
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Dentistry Tehran Medical sciences , Islamic Azad University
Street address
No.4 , 10th Neyestan st. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2018-11-21, 1397/08/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.017
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
clinical attachment level
Timepoint
base-line , 2 and 6 months after phase I periodontal therapy.
Method of measurement
periodontal probe
2
Description
Interleukin-10 in GCF
Timepoint
base-line , 2 and 6 months after phase I periodontal therapy.
Method of measurement
ELISA test
Secondary outcomes
1
Description
Pocket Depth
Timepoint
base-line , 2 and 6 months after phase I periodontal therapy.
Method of measurement
periodontal probe.
2
Description
bleeding on probing.
Timepoint
base-line , 2 and 6 months after phase I periodontal therapy.
Method of measurement
periodontal probe.
Intervention groups
1
Description
Intervention group 1: diode laser 940 nm (Ezlase, biolase, USA) , 1 W , 20 sec.
Category
Treatment - Devices
2
Description
Intervention group 2 : laser Er,Cr:YSGG 2780 nm (iPlus, Waterlase, Biolase, USA) 1.5 W , 30 Hz , 11% air , 20% water , pulse duration 140 µs.
Category
Treatment - Devices
3
Description
Control group: phase I periodontal therapy
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, Faculty of Dentistry, Tehran Medical sciences, Islamic Azad University
Full name of responsible person
DR.Ferena Sayar
Street address
department of periodontics, no:4, 10th neyestan st., pasdaran ave.
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 2571
Fax
+98 21 2256 2573
Email
f_sayar@dentaliau.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ferena sayar
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
f_sayar@dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?