Comparative evaluation of the clinical and immunological effects of photodynamic therapy as an adjunctive to scaling and root planing and scaling and root planing alone, in the treatment of moderate to severe chronic periodontitis.
The aim of this study was to evaluate the clinical and immunological effects of photodynamic therapy (PDT) as an adjunctive to scaling and root planing (SRP) on the cytokine profile and clinical parameters in moderate to severe chronic periodontitis. Material and method: A total of 24 patients (14 woman and 10 men) aged 18 to 70 years affected with moderate to severe chronic periodontitis were selected. In each quadrant one of the teeth with probing depth≥4mm was randomly treated with SRP (Control group) and the other was treated with SRP and PDT(Test group). Gingival cervical fluid samples were collected from the deepest part of the periodontal pocket of control and test teeth in baseline and after 3 month. Primary outcome variable include probing depth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121611770N1
Registration date:2013-02-18, 1391/11/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-18, 1391/11/30
Registrant information
Name
Atabak Kashefimehr
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
kashefimehra@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-02-10, 1390/11/21
Expected recruitment end date
2012-11-06, 1391/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the clinical and immunological effects of photodynamic therapy as an adjunctive to scaling and root planing and scaling and root planing alone, in the treatment of moderate to severe chronic periodontitis.
Public title
Effect of photodynamic therapy on inflammatory biomarkers and clinical parameters in moderate to severe chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Moderate to severe Chronic periodontitis; existence of a minimum of 12 teeth in oral cavity with at least three natural teeth in four sites per quadrant; ≥ 3mm of attachment loss in minimum of 30 percent of teeth; presence of at least one site with pocket depth of ≥ 4mm with bleeding on probing in per quadrant. Exclusion criteria: The ingestion of systemic antibiotics within the last one year, non-surgical periodontal treatment within the last 6 months; smoking; uncontrolled Diabetes; liver disease; malignancy; radiotherapy; pregnancy; females on estrogen therapy; allergic reactions to Toluidine blue.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Tabriz university of medical sciences
Street address
Tabrize Dental Faculty, Golgasht street
City
Tabriz
Postal code
5166614711
Approval date
2012-12-22, 1391/10/02
Ethics committee reference number
91182
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 depth
Timepoint
after 3 month
Method of measurement
Periodontal probe
Secondary outcomes
1
Description
Interleukin-1β level in gingival crevicular fluid
Timepoint
After 3 month
Method of measurement
ELIZA Kit
2
Description
TNF-alpha level in gingival crevicular fluid
Timepoint
After 3 month
Method of measurement
ELIZA Kit
3
Description
MMP-9 Level in gingival crevicular fluid
Timepoint
After 3 month
Method of measurement
ELIZA Kit
4
Description
MMP-8 Level in gingival crevicular fluid
Timepoint
After 3 month
Method of measurement
ELIZA Kit
Intervention groups
1
Description
Intervention: Photodynamic therapy and scaling and root planing
Category
Other
2
Description
Control : Scaling and root planing alone
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental Faculty, Department of Periodontics
Full name of responsible person
Dr. Atabak Kashefimehr
Street address
Golgasht Street,Tabriz Dental Faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental and Periodontal Research Center of the Tabriz University of Medical Sciences (Primary sponsor
Full name of responsible person
Dr. Reza Pourabbas
Street address
Tabriz Dental Faculty, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental and Periodontal Research Center of the Tabriz University of Medical Sciences (Primary sponsor