Clinical and radiographic evaluation of applying Plasma rich growth factor(PRGF) with Metformin gel 1% in treating periodontal two-walls intrabony defects
Main gole: the effect of Plasma rich growth factor(PRGF) with Metformin gel 1% in treating periodontal two walls intrabony defects
Design
Randomized clinical trial, with control group, parallel design, double blind
Settings and conduct
Periodontics department ofbabol dentistry faculpatiens with chronic periodontitis
Randomized sampling, doubleblind
Blinded groups: participants, outcome measurer
Participants/Inclusion and exclusion criteria
Selection criteria: 1.Age at least 18 years 2.Chronic periodontal disease with two wall intrabony defects 3.Similar plaque index( under 15%) 4.The ability to maintain proper oral hygiene; exclusion criteria: 1.Pregnancy 2. Coagulation problems 3.Usage of drugs with iteraction with platellet 4.Usage of drugs with interaction with wound healing 5.Any systemic or topical disease which contra-indicated to periodontal treatment 6.Allergy to surgical materials 7.Infective disease (Hepatitis, AIDS, Tuberclosis)
Intervention groups
1.Debridement alone 2.Debridement with applying metformin gel 1% 3. Debridement with applying PRGF 4.Debridement with applying PRGF & metformin gel 1%
Dental Faculty of University of Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
n.jenabian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-20, 1396/01/31
Expected recruitment end date
2017-10-01, 1396/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and radiographic evaluation of applying Plasma rich growth factor(PRGF) with Metformin gel 1% in treating periodontal two-walls intrabony defects
Public title
evaluation of applying Plasma rich growth factor(PRGF) with Metformin gel 1% in treating periodontal intrabony defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Chronic periodontal diseas with with two wall intabony defects
Similar plaque index(under 15%)
ََAbility to maintaing oral hygiene
Signing of consenting form
Exclusion criteria:
Pregnancy
Existing of coagulation problems
use of drugs which interact with platellet
use of drugs which interact with wound healing
Allergy to surgical materials
Infective disease( Hepatitis, AIDS, Tuberclosis)
Any topical or systemic disease which containdicated to periodontal treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
Blinding (investigator's opinion)
Double blinded
Blinding description
patients do not aware of treatment group which they included
outcome measurer is different from whom that cures patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committeeof babol university of medical science
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
MUBABOL.REC.1396.49
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
vertical clinical attachment level
Timepoint
at the begining of study and immediately before surgery, 3 and 6 months after sergury
Method of measurement
with perodontal probe
2
Description
gingival index
Timepoint
at the beginning of study, immediately before sugery
Method of measurement
absevational (sillness & Loe)
3
Description
VPD(vertical probing depth)
Timepoint
at the beginning of study, immediately before sugery
Method of measurement
with perodontal probe
4
Description
radiologic outcomes
Timepoint
at the beginning of study and 6 months after study
Method of measurement
parallel technic by means of digital sensor size 2(Soredex.Helsinki-finland)by Rinndentsply film holder
Secondary outcomes
empty
Intervention groups
1
Description
interventional group:open flap debridement with metformin gel 1%
Category
Treatment - Surgery
2
Description
Intervention group 2: open flap debridement with plasma-rich growth factor
Category
Treatment - Surgery
3
Description
Intervention group 3: Open flap debridement with metformin gel 1% and plasma-rich growth factor
Category
Treatment - Surgery
4
Description
Control group: Open flap debridement
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology departmet of Babol dental faculty
Full name of responsible person
shabnam khalifehzadeh
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
shabnam.kh63ii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
niloofar jenabian
Street address
Ganjafrooz Ave.
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
نیلوفر جنابیان
Position
associated professer
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
niloofar jenabian
Position
associated professer
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
shabnam khalifehzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
shabnam.kh63ii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available