Comparing the efficiency of diode laser 940 nm and Er, Cr:YSGG 2780 nm on clinical indices and MMP-13 level during phase I periodontal therapy of chronic periodontitis
the effect of 2 wave-lenght laser therapy with SRP on GCF MMP-13 levels in chronic periodontitis
Design
clinical trial , double-blind, split-mouth
Settings and conduct
periodontics department, Islamic Azad university of medical science
split-mouth design on 16 patients with 6 months follow up
double blind study(participant and investigator)
Participants/Inclusion and exclusion criteria
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 groups: 2 quadrants will be treated by diode laser 940nm or Er,Cr:YSGG 2780nm following SRP(scaling and root planing).
control group: the third quadrant will recieve only SRP treatment
Comparing the efficiency of diode laser 940 nm and Er, Cr:YSGG 2780 nm on clinical indices and MMP-13 level during phase I periodontal therapy of chronic periodontitis
Public title
The effect of laser therapy on MMP-13 level during periodontal treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
systemic health
Having 16 teeth or more
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)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
investigator will not aware of the control and test sites, she only records clinical data.
because of application of 2 wave-length laser,participants will not aware of type of recieved treatment in each quadrant
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
19585/175
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.020
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
matrix metalloproteinase-13
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?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Ferena Sayar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4 ,9th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
f_sayar@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ferena Sayar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, 9th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
f_sayar@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ferena Sayar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, 9th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
f_sayar@dentaliau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD