Protocol summary

Summary
The present study compared the clinical and micro biologic effectiveness of the photodynamic therapy as an adjunctive treatment modality for the nonsurgical treatment in the chronic periodontitis. Patients with moderate to advanced periodontitis and at least 2 teeth with PD between 4-10mm with BOP in each quadrant are included and patients with history of systemic disease such as metabolic and endocrinal diseases are excluded. Patients are recruited from people refer to periodontics department of Shahid Beheshti University Of Medical Science. Using sample size estimation software 18 sample was attained. Each patient will receive different treatment modalities in each quadrant. Randomization was done by toss of coin for quadrants and treatment modalities. based on randomization first quadrant receive SRP (control), second modality is laser curettage with Diode laser (810nm and 1.5W) after SRP, third modality is photodynamic therapy (0.2W) after SRP and forth modality is pocket decontamination (1W) and SRP after 48h.periodontal parameters before, 1month and 3 months after treatment will measure and register .measurements will done by a calibrated probe in 6 site around each tooth. These parameters are; Probing Depth, Clinical Attachment Level and Bleeding On Probing. Microbiologic assessments will done base on samples from baseline, 1month and 3 months after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015022221180N1
Registration date: 2015-04-10, 1394/01/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-10, 1394/01/21
Registrant information
Name
Rojin Taliee
Name of organization / entity
Shahid Beheshti University of Medical Sciences Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
rojintaliee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Science Research center Of Shahid Beheshti University of Medical SciencesDental School
Expected recruitment start date
2013-12-25, 1392/10/04
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Effectiveness of photodynamic Therapy as an Adjunct to Nonsurgical Periodontal Treatment
Public title
Clinical Effectiveness of photodynamic Therapy as an Adjunct to Nonsurgical Periodontal Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: moderate to advanced chronic periodontitis Generalized; at least 2 teeth in each quadrant with pocket depth4-10mm with BOP; at least 5 teeth in each quadrant Exclusion criteria: history of systemic disease; pregnancy and breast feeding; high dose steroid therapy; history of radiotherapy; smoking; orthodontic treatment; antibiotic therapy in 6 months ago; mobility type 3; periodontal treatment in 6 months ago
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was don by toss of coin

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Science Research Center Shahid Beheshti University of Medical Sciences
Street address
Daneshju blvd, Velenjak, Tehran
City
Tehran
Postal code
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
20

Health conditions studied

1

Description of health condition studied
moderate to advanced chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis

Primary outcomes

1

Description
pocket depyh and clinical attachment level
Timepoint
befor ,1 and 3 months after treatment
Method of measurement
with calibrated wiliams prob

Secondary outcomes

1

Description
bleeding on probing
Timepoint
befor,1month and 3 months after treatment
Method of measurement
with calibrated prob ,subjective: yes or no

Intervention groups

1

Description
"control group ": scaling and root planning
Category
Treatment - Other

2

Description
"intervention groups": photodynamic therapy and scaling
Category
Treatment - Other

3

Description
"intervention groups": laser curettage and scaling
Category
Treatment - Other

4

Description
"intervention groups": first laser then scaling
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Patients Refer to Shahid Beheshti University of Medical Sciences Dental School
Full name of responsible person
Dr Rojin Taliee
Street address
Daneshju blvd, Velenjak, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental Research Center,Research Institue of Dental Science,Shahid Beheshti University of Medical Sci
Full name of responsible person
Dr Rojin Taliee
Street address
Daneshju blvd, Velenjak, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Center,Research Institue of Dental Science,Shahid Beheshti University of Medical Sci
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 University of Medical Sciences Dental School
Full name of responsible person
Dr Rojin Taliee
Position
Doctor
Other areas of specialty/work
Street address
Code 18, Mizban Alley, Ghalamestan St, Valiasr St, tehran
City
Tehran
Postal code
Phone
+98 21 2271 2430
Fax
+98 21 2271 1836
Email
rojintaliee@sbmu.ac.ir ; rojintaliee@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences Dental School
Full name of responsible person
Dr. Mohammad Reza Talebi Ardekani
Position
periodontist
Other areas of specialty/work
Street address
Code1, 6th Narenjestan St, Farmanie St, Tehran
City
Tehran
Postal code
Phone
+98 21 2228 9264
Fax
+98 21 2228 9264
Email
m-talebi-2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences Dental School
Full name of responsible person
Dr Rojin Taliee
Position
Doctor
Other areas of specialty/work
Street address
Code 1, Mizban St, Ghalamestan St, Valiasr St, Tehran
City
Tehran
Postal code
Phone
+98 21 2271 2430
Fax
+98 21 2271 1836
Email
rojintaliee@sbmu.ac.ir; rojintaliee@gmail.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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