The purpose of this study is to evaluate effects of topical erythropoietin gel on nonsurgical treatment of chronic periodontitis. In this study 15 patients whith chronic periodontitis which have 2 cross arch area whith more than 5mm probing depth are choosed. After scaling and root planing(SRP) erythropoietin is applied in one side (test side) and pacebo is applied in other side(control side).Before SRP, baseline examination and recording of all study parameters (gingival index( GI), bleeding index(BOP), plaque index (PI), probing depth (PD), clinical attachment level(CAL) is perofrmed by UNC15 probe by a blinde examiner. Patients are treated with full mouth supra- and sub-gingival scaling and root planning, then two contralateral teeth in the similar anatomic regions (two canines, two premolars or two molars) were randomly assigned in test or control groups with coin toss method. EPO is applied in one side(test) and placeb in other side(control) for 5 times during the first 2 weeks. patient are asked not to use any mouthwash or antibitics during the study period. After 3 monthes, clinical parameters are re-evaluated to evaluate effects of topical erythropoietin gel on non-surgical treatment of chronic periodontitis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091636203N1
Registration date:2017-11-06, 1396/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-06, 1396/08/15
Registrant information
Name
Hoori Asl Roosta
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 2345
Email address
h-aslroosta@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
the study is funded by executive research team.
Expected recruitment start date
2017-09-16, 1396/06/25
Expected recruitment end date
2018-01-16, 1396/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of topical erythropoietin gel on non-surgical treatment of chronic periodontitis: a split mouth randomized clinical trial
Public title
Effects of topical erythropoietin gel on non-surgical treatment of chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age>18; No SRP during last 6 monthes; at least 2 cross arch teeth with more than 5mm probing depth.
Exclusion criteria: Patients whit uncontrolled systemic disease(diabetes mellitus, cancer,heart disease); Systemic antibiotics taken within previous 2 months; Enrollment in an other clinical trials; Current smokers; Patients with aggressive or narcotizing types of periodontitis.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Dental School Of Tehran University Of Medical Sciences
Street address
Dental School Of Tehran University Of Medical Sciences, North Karegar Street ,Tehran
City
Tehran
Postal code
Approval date
2017-08-12, 1396/05/21
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.3139
Health conditions studied
1
Description of health condition studied
chronic periodontitis
ICD-10 code
k05.4
ICD-10 code description
chronic periodontitis
Primary outcomes
1
Description
Probing Depth
Timepoint
Before SRP and after months
Method of measurement
By UNC-15 probe
2
Description
Clinical Attachment Level
Timepoint
Before SRP and after3 monthes
Method of measurement
UNC-15 probe
3
Description
Bleeding On Probing
Timepoint
Before SRP and after monthes
Method of measurement
Sulcular bleeding index (muhleman)
4
Description
Gingival index
Timepoint
Before SRP and after3 monthes
Method of measurement
By observation. no inflamation=0 mild inflamation and color change which doesnt involve papilla=1, inflamation like group 1 which involves papilla=2 shine and redness and inflamation at margin or papilla=3
5
Description
Plaque Index
Timepoint
Before SRP and after3 monthes
Method of measurement
By moving prob on tooth surface, no plaque=0, plaque in cervical1/3 only recognizable by prob =1, plaque in cervial1/3 reconizable by abservation=2
Secondary outcomes
empty
Intervention groups
1
Description
In test group after measusing the parameters , SRP will be done.Then a complex of 1cc of EPO gel(4000IU) and 1 cc of carboxymethyl cellulose gel will be applied in the site for 5 times durin 2 weeks.
Category
Treatment - Drugs
2
Description
In control group after measusing the parameters , SRP will be done.Then 2 cc of carboxymethyl cellulose gel will be applied in the site for 5 times durin 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School Of Tehran University Of Medical Sciences
Full name of responsible person
Street address
Dental School Of Tehran University Of Medical Sciences, Karegar Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Department Of Tehran University Of Medical Science
Full name of responsible person
Dr Mohammadali Sahraiyan
Street address
Research and Technology Department, Second floor, Central Organization of Tehran University, Ghods Street, Keshavarz Blvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Department Of Tehran University Of Medical Science
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 Of Tehran University Of Medical Sciences
Full name of responsible person
Mahsa Vafaei
Position
Dentistry Student
Other areas of specialty/work
Street address
Dental School Of Tehran University Of Medical Sciences, North Karegar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 4608 5883
Fax
Email
mahsa.vafaei22@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School Of Tehran University Of Medical Sciences
Full name of responsible person
Dr Hoori Asl Roosta
Position
PHD
Other areas of specialty/work
Street address
Dental School Of Tehran University Of Medical Sciences, Karegar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8801 5950
Fax
Email
h-aslroosta@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School Of Tehran University Of Medical Sciences
Full name of responsible person
Mahsa Vafaei
Position
Dentistry Student
Other areas of specialty/work
Street address
Dental School Of Tehran University Of Medical Sciences, North Karegar Street,Tehran
City
Tehran
Postal code
Phone
+98 21 4608 5883
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)