Clinical assessment of "Er, Cr: YSGG Laser" and "scaling and Root planning" in the Treatment of Patients with Mild to Moderate Periodontitis: A Randomized Clinical Trial
Evaluation of clinical parameters following application of Er-YAG laser in comparison with ultrasonic method for scaling and root planning.
Design
A randomized controlled clinical trial with parallel double blinded groups
Settings and conduct
15 Patients will be randomly selected from the periodontics department of Zahedan University of Medical Sciences. SRP treatment will be performed for both half-jaws of patients.Then the laser will be used on the intervention side. because of blinding of the participant, the laser will turned off for control side.
One and three months after treatment the parameters: plaque index - probing depth - BOP - CAL and gingival resection rate will be performed by an unaware person from intervention side.
Participants/Inclusion and exclusion criteria
No systemic disease - no pregnancy and lactation - no tobacco products Consumption - no systemic antibiotic use at least 6 months before, during and 12 months after treatment
Intervention groups
In the control group, patients receive only SRP treatment.
In the intervention group, patients are treated with SRP and laser.
Clinical assessment of "Er, Cr: YSGG Laser" and "scaling and Root planning" in the Treatment of Patients with Mild to Moderate Periodontitis: A Randomized Clinical Trial
Public title
Comparison Effects of Er,Cr:YSGG laser and SRP in the Treatment of Patients with Mild to Moderate Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 40 years
mild to moderate periodontitis
Exclusion criteria:
any kind of Systemic diseases
Pregnancy and lactation
Tobacco consumption
Use antibiotics from 6 months ago to 12 months after treatment
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
The study is split mouth and each patient's half-jaw is considered as a sample.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this split mouth study , SRP Treatment will done by ultrasonic device for both half-jaw of each patients.
Laser application will done for intervention half-jaw and for control side the laser will be off . Evaluation of patients in subsequent sessions will done by a person who is unaware of control and intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZaUMS Main campus, Jenat Boulevard., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.ZAUMS.REC.1398.184
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
Plaque index
Timepoint
Before treatment - 1 month after treatment - 3 month after treatment
Method of measurement
Clinicial evaluation
2
Description
Bleeding on probing
Timepoint
Before treatment - 1 month after treatment - 3 month after treatment
Method of measurement
Clinicial evaluation
3
Description
Attachment loss
Timepoint
Before treatment - 1 month after treatment - 3 month after treatment
Method of measurement
Clinicial evaluation
4
Description
Gingival recession
Timepoint
Before treatment - 1 month after treatment - 3 month after treatment
Method of measurement
Clinicial evaluation
5
Description
Probing depth
Timepoint
Before treatment - 1 month after treatment - 3 month after treatment
Method of measurement
Clinicial evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Scaling and root planning and laser radiation
Category
Treatment - Devices
2
Description
Control group: Scaling and root planning without laser radiation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Ansari Moghadam
Street address
College of dentistry , Eastern Azadegan St. , Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
ansarimoghadam@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nourmohammad Bakhshani
Street address
ZaUMS Main campus, Jenat Boulevard., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3342 5765
Email
nmbakhsha@zdmv.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Nadia Taheri
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
nadia.taheri20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Ansari Moghadam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East Azadegan St. - Kooye Tir Andazi - Zahedan College of Dentistry
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
ansarimoghadam@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nadia Taheri
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
nadia.taheri20@gmail.com
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
no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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