Protocol summary

Summary
Comparison of the effects of scaling and root planning with or without photodynamic therapy (with indocyanine green) and 810nm diode laser(LANAP) on clinical parameters and biomarkers of gingival crevicular fluid(IL-1B,IL-4) in chronic periodontitis. The study is a split-mouth double-blind randomized clinical trial, participents were selected from the patients refferd for periodontal tratmentn the department of periodontics of shahid beheshti dental school. Inclusion criteria: good general health; patient presented with chronic periodontitis as defined by periodontist; pateints must have 12 natural teeth with a minimum of three in each quadrant, teeth must have CAL>3 mm & PD>5mm with BOP. Exclusion criteria: systemic diseases including: diabetes mellitus; cancer, HIV, metabolic disorders; pregnancy & lactation; estrogen therapy for female patients; smokers; patient who had received systemic antibiotics within the past 6 months; surgical or non-surgical periodontal treatment within the past 6 months & class III mobility of tooth. Intervention include: 1-photodynamic therapy with laser diode 810 nm, power 0.4 w and indocyanin green+SRP; 2-LANAP with laser diode 810 nm and power 1.5 w+SRP; 3-SRPalone(control). PD, CAL, BOP, IL-1B & IL-4 were defined before and 1 & 3 months after treatment.

General information

Acronym
PDT-LANAP
IRCT registration information
IRCT registration number: IRCT2015060722598N1
Registration date: 2016-05-18, 1395/02/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Mansour Meimandi
Name of organization / entity
Shahid Beheshti Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3075
Email address
meimandim@sbum.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti Dental School
Expected recruitment start date
2015-11-03, 1394/08/12
Expected recruitment end date
2015-11-11, 1394/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of scaling and root planning with or without photodynamic therapy (with indocyanine green) and 810nm diode laser on clinical parameters and biomarkers of gingival crevicular fluid in chronic periodontitis
Public title
Effects of laser on inflamatory periodontal disease(periodontitis)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: good general health; patient presented with chronic periodontitis as defined by periodontist; pateints must have 12 natural teeth with a minimum of three in each quadrant, teeth must have CAL>3 mm & PD>5mm with BOP. Exclusion criteria: systemic diseases including: diabetes mellitus; cancer, HIV, metabolic disorders; pregnancy & lactation; estrogen therapy for female patients; smokers; patient who had received systemic antibiotics within the past 6 months; surgical or non-surgical periodontal treatment within the past 6 months & class III mobility of tooth.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti Dental School
Street address
Shahid Beheshti Dental School, Daneshjou Blvd., Velenjak
City
Tehran
Postal code
1983963113
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.75

Health conditions studied

1

Description of health condition studied
Chronic periodotitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
periodontal depth-
Timepoint
Before treatment,1&3 month after treatmenr
Method of measurement
PD with periodontal probing

2

Description
clinical attachment level
Timepoint
Before treatment,1&3 month after treatmenr
Method of measurement
cal with periodontal probing

3

Description
IL-1B
Timepoint
Before treatment,1&3 month after treatmenr
Method of measurement
ELISA test

4

Description
bleeding on probing
Timepoint
Before treatment,1&3 month after treatmenr
Method of measurement
observation 30-60 sec after pocket probing

5

Description
IL-4
Timepoint
Before treatment,1&3 month after treatmenr
Method of measurement
ELISA test

Secondary outcomes

empty

Intervention groups

1

Description
1-SRP alone(Control).
Category
Treatment - Other

2

Description
Photodynamic therapy with laser diode 810 nm. And 0/4 w and indocyaningreen + srp
Category
Treatment - Drugs

3

Description
Laser diode810 nm and 1/5 w + srp
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodotics Department, Shahid Beheshti Dental School
Full name of responsible person
Dr. Mansour Meimandi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti Dental School
Full name of responsible person
Dr. Azita Tehranchi
Street address
Shahid Beheshti Dental School, Daneshjou Blvd., Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Dental School
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
Shahid Beheshti Dental School
Full name of responsible person
Dr. Mansour Meimandi
Position
Associate Professor,Periodontics Dept
Other areas of specialty/work
Street address
Shahid Beheshti Dental School, Daneshjou Blvd., Velenjak
City
Tehran
Postal code
1983969411
Phone
+98 21 2240 3075
Fax
Email
meimandim@sbum.ac.ir; parisayousefnejad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti Dental School
Full name of responsible person
Dr. Mansour Meimandi
Position
Associate Proffesor, Periodontics Dept
Other areas of specialty/work
Street address
Shahid Beheshti Dental School, Daneshjou Blvd., Velenjak
City
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Fax
Email
meimandim@sbum.ac.ir; parisayousefnejad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti Dental School
Full name of responsible person
Parisa Yousef Nejad
Position
Under graduate student
Other areas of specialty/work
Street address
Shahid Beheshti Dental School, Daneshjou Blvd., Velenjak
City
Tehran
Postal code
Phone
+98 26 3654 1503
Fax
Email
parisayousefnejad@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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