Evaluation of histomorphometric of bone after sinus lift surgery using PRF(Platelet Rich Fibrin)
Design
Two arm parallel group randomized trial with blinded examiner and data analyzer
Settings and conduct
This study aims to evaluate the effect of PRF on bone regeneration in sinus augmentation in combination with Allograft.The study protocole will be performed in Implant Department of School of Dentistry, Mashhad University of Medical Sciences. Sinus floor augmentation using PRF and allograft in test group and Allograft alone in control group. Then histomorphometric analysis performe. In this study examiner and data analyzer will be blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Less than 6 mm of alveolar bone remaining in the floor of the sinus 2.Patient 25 years old and more than 3.Without history of sinus lifting in surgical site
Exclusion Criteria: 1.Patient with a systemic disease like Diabetes, Immune deficiency 2.Patient with acute sinusitis
Intervention groups
Sinus lift using PRF and allograft in the test group and sinus lift just using allograft in the control group
Main outcome variables
Histomorphometric dimensions of bone after sinus lift
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190114042354N1
Registration date:2020-06-23, 1399/04/03
Registration timing:registered_while_recruiting
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Milad Taher
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 8962
Email address
taher.milad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-02, 1398/10/12
Expected recruitment end date
2020-09-02, 1399/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of radiological and histologic bone quality after lateral sinus lift surgery using PRF and allograft: Clinical Trial
Public title
Evaluation of bone quality after lateral sinus lift surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Less than 6 mm of alveolar bone in the floor of the sinus remained
Patient 25 years old and more than
Without history of sinus lift in surgical site
Exclusion criteria:
Medical contraindication for implant surgery
A history of maxillary sinus inflammations.
History of drug abuse
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In our study randomization takes place using Randomization.com website and using a random number that insert in pocket. Patients divide into two groups (test and control) based on odd random number that is in the pocket.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study because our intervention included blood sampling from patients in one group and no sampling in the other group, we are not capable to blind the surgeon and patients, so in our study data analyzer and outcome assessor will be kept blind.
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
2020-01-22, 1398/11/02
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.128
Health conditions studied
1
Description of health condition studied
Bone evaluation after sinus lift surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Histomorphometric dimensions: From these primary measurements, the percentage of newly formed bone in the region of interest , the percentage of remaining bone substitute material , and the percentage of the contour length of the bone substitute material in contact with new bone (bone-to-bone substitute contact) would be calculated.
Timepoint
Radiographic examination before intervention and radiographic , histomorphometric evaluation 6 months after baseline
Method of measurement
Microscope. Photographed with a digital camera (Canon, Tokyo, Japan) mounted on a microscope ((Olympus BX51, Japan). The images will assess with the magnification of 40X
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: open sinus lift surgery using allograft in combination of Platelet rich fibrin. All surgery was performed with local anaesthesia, and the sinus floor augmentation using lateral window approach. after a buccal mucoperiosteal flap was raised, an osteotomy was prepared in the lateral wall of the maxillary sinus. After the Schneiderian membrane was carefully elevated, the grafting material was packed into the space between the sinus floor and the Schneiderian membrane. then a combination of freeze dried bone allograft (DIZG Deutsches Institut für Zell, Germany) and PRF preparation was inserted in sinuses of the test group. The window was covered with the membrane(Cenomembrane, Iran) before flap closure
Category
Treatment - Surgery
2
Description
Control group: sinus lift surgery using only allograftopen sinus lift surgery using allograft in combination of Platelet rich fibrin. All surgery was performed with local anaesthesia, and the sinus floor augmentation using lateral window approach. after a buccal mucoperiosteal flap was raised, an osteotomy was prepared in the lateral wall of the maxillary sinus. After the Schneiderian membrane was carefully elevated, the grafting material was packed into the space between the sinus floor and the Schneiderian membrane. then a combination of freeze dried bone allograft (DIZG Deutsches Institut für Zell, Germany) without PRF preparation was inserted in sinuses of the control group. The window was covered with the membrane(Cenomembrane, Iran) before flap closure
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Milad Taher
Street address
Vakil abad, Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Email
Taher.Milad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Milad Taher
Street address
Vakil Abad Blvd, Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Fax
+98 51 3806 7257
Email
Taher.Milad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?