aim: comparison between clinical and antibacterial effect of phtodynamic therapy and diod laser as adjunctive periodontal therapy in chronic periodontitis
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:IRCT2014040617143N1
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
Ehsan Rafiei
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4066
Email address
e.rafiei@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
clinical and antibacterial effect of photodynamic therapy and diod laser as adjunctive periodontal therapy in chronic periodontitis
Public title
clinical and antibacterial effect of photodynamic therapy and diod laser as adjunctive periodontal therapy in chronic periodontitis
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:
90
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
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street
City
Isfahan
Postal code
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
23810201912011
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
Aggregatibacter actinomycetemcomitans
Timepoint
initial, 2 week, 6 week
Method of measurement
colonies
2
Description
Prevotella intermedia
Timepoint
initial, 2 week, 6 week
Method of measurement
colonies
3
Description
porphyromunas gingivalis
Timepoint
initial, 2 week, 6 week
Method of measurement
colonies
4
Description
pocket depth
Timepoint
initial, 2 week, 6 week
Method of measurement
clinical measurment (mm)
5
Description
bleeding on probing
Timepoint
initial, 2 week, 6 week
Method of measurement
clinical evaluation (+/-)
6
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
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
ehsan rafiei
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Ehsan Rafiei
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
Islamic Azad University of Isfahan (Khorasgan), 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
Islamic Azad University of Isfahan(Khorasgan), Dental School
Full name of responsible person
Ehsan Rafiei
Position
postgraduated student 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
dr_ehsan60@yahoo.com, e.rafiei@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Ehsan Rafiei
Position
postgraduated student 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
dr_ehsan60@yahoo.com, E.rafiei@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Isfahan (Khorasgan), Dental School
Full name of responsible person
Ehsan Rafiei
Position
postgraduated student of periodontics
Other areas of specialty/work
Street address
Islamic 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)