Comparative clinical and radiographic evaluation of L-PRF and EMD use in regeneration of intrabony periodontal defects with GTR technique in patients with periodontitis
Aim of this study is to compare the effect of using Emdogain and Leukocyte-Platelet Rich Fibrin in Guided Tissue Regeneration (GTR) technique. Samples will be selected from patients referring to Periodontal Department of Hamedan Dental School who has at least one periodontal defect that needs reconstruction and bone grafting. Also patients should not be smoker, pregnant or having systemic disease. Sample size is determined regarding to previous studies and amount of all patients attended to this center. Samples will be divided into three groups, GTR, GTR with using Emdogain and GTR with using Leukocyte-Platelet Rich Fibrin by simple sampling. In intervention and treatment stage, surgeries will perform for patients divided in all three groups. Inflammation and amount of bone formation will be evaluated by clinical and radiographic factors before treatment and three months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022716141N3
Registration date:2017-05-08, 1396/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Janet Moradi Haghgou
Name of organization / entity
Dental Faculty
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 1074
Email address
j.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2017-03-01, 1395/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative clinical and radiographic evaluation of L-PRF and EMD use in regeneration of intrabony periodontal defects with GTR technique in patients with periodontitis
Public title
Comparative evaluation of two different regenerative materials in reconstruction of periodontal defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least have one intrabony periodontal defect.
Exclusion criteria: Smoking; Pregnancy; Systemic disease.
Age
No age limit
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple sampling will be done by sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Dental School, Hamedan University of Medical Sciences, Shahid Fahmideh st.
City
Hamedan
Postal code
Approval date
2016-04-24, 1395/02/05
Ethics committee reference number
IR.UMSHA.REC.1395.66
Health conditions studied
1
Description of health condition studied
Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic pericoronitis Periodontitis: NOS complex simplex
Primary outcomes
1
Description
Bone formation
Timepoint
3 months after surgery
Method of measurement
Probing depth
2
Description
Bone formation
Timepoint
3 month after surgery
Method of measurement
Radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Guided tissue regeneration surgeries will perform for the patients with periodontal defects with GTR technique and Emdogain added to grafting bone material.
Category
Treatment - Surgery
2
Description
Intervention group 2: Guided tissue regeneration surgeries will perform for the patients with periodontal defects with GTR technique and L-PRF added to grafting bone material.
Category
Treatment - Surgery
3
Description
Control group: Guided tissue regeneration surgeries will perform for the patients with periodontal defects with GTR technique alone.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Erfan Abbasi
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Dental School of Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Zandi
Street address
Dental School, Hamedan University of Medical Sciences, Shahid Fahmideh st.
City
Hamedan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Dental School of Hamedan University of Medical Sciences
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
Periodontal assistant
Full name of responsible person
Erfan Abbasi
Position
Post graduate
Other areas of specialty/work
Street address
Dental School, Hamedan University of Medical Sciences, Shahid Fahmideh st.
City
Hamedan
Postal code
Phone
+98 81 3835 4140
Fax
Email
erfan_a90a@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Periodontal assistant
Full name of responsible person
Erfan Abbasi
Position
Post graduate
Other areas of specialty/work
Street address
Dental School, Hamedan University of Medical Sciences, Shahid Fahmideh st.
City
Hamedan
Postal code
Phone
+98 81 3835 4250
Fax
Email
erfan_a90a@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Periodontal assistant
Full name of responsible person
Erfan Abbasi
Position
Post graduate
Other areas of specialty/work
Street address
Dental School, Hamedan University of Medical Sciences, Shahid Fahmideh st.
City
Hamedan
Postal code
Phone
00
Fax
Email
erfan_a90a@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)