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Assessment of the effect of photodynamic therapy on treatment of moderate-to-severe periodontitis

Protocol summary

Summary
In this single-blind clinical trial, 30 patients who had referred to Faculty of Dentistry, University of Babol will be selected based on inclusion criteria (having at least 20 teeth in the mouth, etc.) and exclusion criteria (pregnancy, etc.). The first 10 subjects form the first intervention group (Photo-dynamic Therapy), and the other 20 ones will be randomly and equally divided into the control group (under scaling/root planting (SRP) treatment) and the second intervention group (under a combination of Photo-dynamic Therapy and SRP). In the second intervention group, treatment processes of Photo-dynamic Therapy will be done immediately after SRP. The light-sensitive material used in the study (manufacturer: CMS Dental, Denmark) contains 10 milligrams per milliliter methylene Blue (16, 18, and 19) that will be directly applied into the periodontal pockets for at least 60 seconds. Then, using Photo-San system (manufactured by the same company) and by means of a 15-mm perio-tip located inside each periodontal pocket, all surfaces of the tooth are exposed for at least 30 seconds and the pocket is rinsed. Given the uniform distribution of light in this system, it will be possible to distribute it throughout the periodontal pockets. Primary outcomes including pocket probing depth (PPD) (in millimeter per six areas of each tooth), bleeding on probing (BOP), and clinical attachment level (CAL) will be measured. All measurements will be performed by another clinician one, three, six, and twelfth weeks after the start of the trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512251760N44
Registration date: 2016-02-23, 1394/12/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-23, 1394/12/04
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of photodynamic therapy on treatment of moderate-to-severe periodontitis
Public title
Assessment of the effect of photodynamic therapy on treatment of moderate-to-severe periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age older than 18 years old; having at least 20 teeth in the mouth; having at least one area with probing depth of four millimeters in at least two quadrants of the mouth (with bleeding on probing light); the plaque index, less than thirty percent. Exclusion criteria: pregnancy; received scaling and root planing procedures or antibiotic therapy in the last six months؛ systemic disease affecting periodontal health; smoking.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Groups based on all parameters (including PPD, CAL, BOP and plaque index) and with regard to the inclusion and exclusion criteria will be mentioned in the same building. All calculations weeks, third, sixth and twelfth after treatment by a clinicians will no longer do. Blindness study done.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
Postal code
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
MUBABOl.REC.1394.206

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
Probing pocket depth
Timepoint
A week after the start of the study and at weeks three, six and twelve after treatment
Method of measurement
Clinical

2

Description
Clinical attachment level
Timepoint
A week after the start of the study and at weeks three, six and twelve after treatment
Method of measurement
Clinical

3

Description
Bleeding on probing(BOP)
Timepoint
A week after the start of the study and at weeks three, six and twelve after treatment
Method of measurement
Clinical

Secondary outcomes

empty

Intervention groups

1

Description
Control groups: This group will be under scaling/root planting (SRP) treatment.
Category
N/A

2

Description
Intervention group 1: In this group, Photo-dynamic Therapy will be used.
Category
Treatment - Other

3

Description
Intervention group 2: A combination of Photodynamic Therapy and SRP will be used in this group. Treatment processes of Photodynamic Therapy will be done immediately after SRP. The light-sensitive material used in the study (manufacturer: CMS Dental, Denmark) contains 10 milligrams per milliliter methylene Blue (16, 18, and 19) that will be directly applied inside the periodontal pockets for at least 60 seconds. Then, using PhotoSan system (manufactured by the same company) and by means of a 15-mm perio-tip located inside each periodontal pocket, all surfaces of the tooth are exposed for at least 30 seconds and the pocket is rinsed. Given the uniform distribution of light in this system, it will be possible to distribute it throughout the periodontal pockets.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental colleges of Babol
Full name of responsible person
Dr. Ida Mirzaee
Street address
Dental College, Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganjafrooz Avenue, Babol University of Medical sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Babol University of Medical Sciences
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
Dental College of Babol
Full name of responsible person
Dr. Ida Mirzaee
Position
Post graduate student of periodontology
Other areas of specialty/work
Street address
Dental College, Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
ida.mirzaee65@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental College of Babol
Full name of responsible person
Dr. Babak Amoian
Position
Professor of Periodontology
Other areas of specialty/work
Street address
Dental College, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 3229 1408
Fax
Email
amoian@perio.org
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafrooz Avenue Babol
City
Babol
Postal code
Phone
Fax
Email
ngh_pa@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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