comparative evaluation of platelet rich fibrin membrane and allograft membrane along with demineralized freeze dried bone allograft in the treatment of mandibular grade II furcation defects.
comparative evaluation of platelet rich fibrin membrane and allograft membrane along with demineralized freeze dried bone allograft in the treatment of mandibular grade II furcation defects.
Design
two arm parallel group randomized trial with blind postoperative care and outcome assessment
Settings and conduct
This study is a double blinded randomized clinical trial that will conduct on 30 Grade II mandibular furcation defects in the Department of Periodontology, Dental College, Mashhad Universiyt of Medical Sciences..In Control Group followed by open flap debridment (OFD) , placement of DFDBA material and collagen membrane (Regen™) will done. . For Test Group placement of DFDBA material and PRF membrane will done.All clinical parameters such as Gingival index (GI), probing depth (PD), vertical clinical attachment level (VCAL), horizontal clinical attachment level (HCAL), and gingival marginal level (GML) will record at baseline and after 6-month postoperative.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patient whit Grade II furcation involvement in one of their mandibular molars,the horizontal depth defect with minimum 3 mm
Exclusion criteria:Patients with complicated medical history,pregnant and/or lactation females,Patients with a habit of using of tobacco products and smoking,teeth with Grade II mobility,The presence of cervical lesions,cervical restoration, cervical enamel pearls
Intervention groups
use of PRF with DFDBA material in test group
and use of allograft membrane along with DFDBA in control group
Main outcome variables
comparison horizontal clinical attachment level at baseline and six months postoperative.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191129045539N1
Registration date:2020-01-01, 1398/10/11
Registration timing:prospective
Last update:2020-01-01, 1398/10/11
Update count:0
Registration date
2020-01-01, 1398/10/11
Registrant information
Name
Mohsen Kashani nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 0502
Email address
kashaninezhadm971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative evaluation of platelet rich fibrin membrane and allograft membrane along with demineralized freeze dried bone allograft in the treatment of mandibular grade II furcation defects.
Public title
Effect of PRF membrane in treatment of furcation defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient whit Grade II furcation involvement in one of their mandibular molars
the horizontal depth defect with minimum 3 mm
Exclusion criteria:
Patients with complicated medical history
pregnant and/or lactation females
Patients with a habit of using of tobacco products and smoking
teeth with Grade II mobility
The presence of cervical lesions,cervical restoration, cervical enamel pearls
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
in our study randomization take place using randomization.com website and random number has insreted in pocket.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this study because of our intervention include using prf in one group,er are not capable to blind surgeon so in our study blindness perform for outcome assessor and data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakil abad Blvd,Mashhad,dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.066
Health conditions studied
1
Description of health condition studied
periodontal disease
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
Horizontal clinical attachment level
Timepoint
at baseline and after 6-month postoperative
Method of measurement
with use periodntal probe
Secondary outcomes
1
Description
probing depth
Timepoint
at baseline and after 6-month postoperative
Method of measurement
using periodontal probe
2
Description
vertical clinical attachment level
Timepoint
at baseline and after 6-month postoperative
Method of measurement
using periodontal probe
3
Description
ایندکس لثه ای
Timepoint
at baseline and after 6-month postoperative
Method of measurement
using periodontal probe
Intervention groups
1
Description
Intervention group: The furcation defects by placement of PRF membrane and DFDBA material will graft
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Universiyt of Medical Sciences
Full name of responsible person
Mohsen kashani nejad
Street address
Vakil abad Blvd,Mashhad dental faculty
City
Mahhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3846 0502
Email
kashaninezhadm971@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Zare Mahmoodabadi
Street address
Vakil abad Blvd,Mashhad,dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Email
kashaninezhadm971@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Kashani nejad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil abad Blvd,Mashhad,dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Email
kashaninezhadm971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Kashani nejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil abad Blvd,Mashhad,dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Email
kashaninezhadm971@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Kashani nejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil abad Blvd,Mashhad,dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 5257
Email
kashaninezhadm971@mums.ac.ir
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