Effect of photodynamic therapy and diod laser as adjunctive periodontal therapy on inflammatory mediators levels in gingival cervicular fluid and clinical periodontal status
Aim: Comparison between photodynamic therapy and diod laser as adjunctive periodontal therapy on inflammatory mediators levels in gingival crevicular and clinical periodontal status
Study design: Randomized, single blind, no placebo, multi-center, population: patients aged 30-60 years old that have generalized chronic moderate to severe periodontitis.
Inclusion criteria: Without particular systemic disease, plaque index < %40
exclusion criteria: Patients that received broadcast systemic antibiotics during 6 mount ago, patients that received periodontal treatment during one year ago
Sample size: 15 quadrant in each group
Intervention studied: Treatment with diod laser, photodynamic therapy
Interventional time: Initial, 2 week, 6 week
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040617145N1
Registration date:2014-06-17, 1393/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-17, 1393/03/27
Registrant information
Name
faraz teymouri
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Country
Iran (Islamic Republic of)
Phone
+98 53540660311
Email address
f.teymouri@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of photodynamic therapy and diod laser as adjunctive periodontal therapy on inflammatory mediators levels in gingival cervicular fluid and clinical periodontal status
Public title
Effect of photodynamic therapy and diod laser as adjunctive periodontal therapy on inflammatory mediators levels in gingival cervicular fluid and clinical periodontal status
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient with generalized chronic moderate to severe periodontitis that have at least four sites with 4-6 mm pocket depth in per quadrant; Patients aged 30-60 yeas old
Exclusion criteria: Patient with particular systemic diseases; Patients under treatment with special medication; Smokers and patients consume alcohol; Patients that received systemic antibiotics during 6 month ago
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental School, Islamic Azad University of Isfahan(Khorasgan)
Street address
Islamic Azad University of Isfahan(Khorasgan), Jey Street
City
Isfahan
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
92013110603
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
Interluekin 1b
Timepoint
Initial, 2 week, 6 week
Method of measurement
Perticular kit of elisa
2
Description
Interluekin 17
Timepoint
Initial, 2 week, 6 week
Method of measurement
Perticular kit of elisa
3
Description
Pocket Depth
Timepoint
Initial, 2 week, 6 week
Method of measurement
Clinical measurment (mm)
4
Description
Bleedin on Probing
Timepoint
Initial, 2 week, 6 week
Method of measurement
Clinical evaluation (+/-)
5
Description
clinical attachment loss
Timepoint
initial, 2 week, 6 week
Method of measurement
clinical measurment (mm)
Secondary outcomes
empty
Intervention groups
1
Description
Laser therapy
Category
Treatment - Other
2
Description
Photodynamic Therapy
Category
Treatment - Other
3
Description
Control (Phase I periodontal treatment)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dept. of Periodontics, Islamic Azad Dental School Khorasgan Branch, Isfahan, Iran
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental School, Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
Faraz Teymouri
Street address
Dental School, Islamic Azad University of Isfahan (Khorasgan), Jey Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental School, Islamic Azad University of Isfahan (Khorasgan)
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 School, Islamic Azad University of Isfahan(Khorasgan)
Full name of responsible person
Faraz Teymouri
Position
Assistant of periodontics
Other areas of specialty/work
Street address
Dental School, Islamic Azad University of Isfahan (Khorasgan), Jay Stree
City
Isfahan
Postal code
Phone
+98 31 1535 4066
Fax
Email
faraz_teymouri@yahoo.com, f.teymouri@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
Faraz Teymouri
Position
Assistant of periodontics
Other areas of specialty/work
Street address
Islamic Azad University of Isfahan (Khorasgan), Jey Street
City
Isfahan
Postal code
Phone
+98 31 1535 4066
Fax
Email
faraz_teymouri@yahoo.com, f.teymouri@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
Faraz Teymouri
Position
Assistant of periodontics
Other areas of specialty/work
Street address
Azad University of Isfahan (Khorasgan), Jay Street
City
Isfahan
Postal code
Phone
+98 31 1535 4066
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)