main goal
Radiographic comparison of maxillary sinus density and height by CBCT with and without the use of PRF with biomaterials
Specific goals
radiographic Comparison of sinus floor density between study groups
Radiographic comparison of sinus floor height between study groups
functional goal:
increase the success of treatment in sinus lift surgery and implant treatments, reduce recovery time, pain , complications after surgery, costs, eliminate the need for hospitalization
Design
The study with control and intervention group in each patient is performed in parallel without blinding on 20 people. Simple randomization is done with cans written on the right or left side of the patient.
Settings and conduct
This study is performed in the specialized dental clinic of the Azad Dentistry School of Tabriz, Randomly sinus lift with PRF and biomaterials is performed on one side. and opposite side, only biomaterials are used.
Participants/Inclusion and exclusion criteria
Entry requirements:
Bilateral partial edentulousness or complete maxillary edentulousness؛ maximum height of the maxillary sinus floor bone is 5 mm on both sides ؛ no systemic disease or inflammatory disease around the sinus ؛ not taking drugs that disrupt grafts
No entry conditions:
sufficient bone height at the floor of the sinus on each site ؛ Presence of systemic disease or inflammatory disease around the sinuses ؛ use of drugs that disrupt grafts ؛ Patient dissatisfaction after a complete description of the treatment process
Intervention groups
In this study, the split mouth method is used in such a way that in each patient there is both a control and intervention group.Randomly used PRF with biomaterials are used on one side of the patient's sinus lift surgery, and on the other side the transplant is performed only through biomaterials.
Main outcome variables
density of sinus bone ؛height of sinus bone ؛use of PRF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210626051717N1
Registration date:2021-12-29, 1400/10/08
Registration timing:registered_while_recruiting
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Rana Khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3281 7829
Email address
www.raanakhalafi@istu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiologic evaluation of density and height of maxillary sinus use of CBCT with and without use of PRF and biomaterials(Randomized clinical Trial)
Public title
Evaluation effect of use PRF in maxillary sinus bone graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 20 to 80 years old male and female without systemic disease
Bilateral partial edentulousness of posterior part of maxilla or complete edentulousness
Maxillary sinus floor bone height below 5 mm
Exclusion criteria:
Existence of uncontrolled systemic diseases
Use of immunosuppressive drugs and bisphosphonates
Head and neck radiotherapy
Presence of pathology and inflammatory diseases in maxillary sinus
Existence of active periodontal disease behind the maxilla
Irregular and chronic smoking
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral maxillary sinus bone graft on one side with fibrin-rich platelet intervention with biomaterials and on the other without fibrin-rich platelet intervention with biomaterials only randomly
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is done by simple randomization method with an individual unit so that at the beginning of each surgery in a patient the word left or right is written on the closed cans and by removing a can randomly and observing the word Right or left It is indicated that the fibrin-rich platelet sample is used in the patient's right sinus lift surgery or in left site and in the opposite side only biomaterials are used
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Medical Sciences, Tabriz Branch
Street address
Complex No. 2 of Islamic Azad University, Tabriz Branch. medical School .First Basmanj Road.Ahar three ways
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2021-12-18, 1400/09/27
Ethics committee reference number
IR.IAU.TABRIZ.REC.1400.132
Health conditions studied
1
Description of health condition studied
Investigation of height and density of maxillary sinus floor bone on both sides of posterior maxilla
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
using and not using fibrin-rich platelets with biomaterial
Timepoint
6 months after graft
Method of measurement
Is an independent variable that is measured in terms of use or non-use
2
Description
Maxillary sinus floor bone density
Timepoint
6 months after graft
Method of measurement
Hansfield number from CBCT
3
Description
Height of maxillary sinus floor bone
Timepoint
6 months after graft
Method of measurement
Based on millimeters from CBCT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, patients aged 20-80 years without systemic disease with bilateral partial edentulousness or complete edentulousness whose remaining bone height behind the maxilla is less than 5 mm will be selected. Prior to sinus lift surgery, 20 to 40 mm of blood is collected from the patient's vein in sterile test tubes without anticoagulant and will be immediately centrifuged at 3000 rpm for 10 minutes. . As a result of the activation of the coagulation cascade and the formation of a three-layer fibrin network, including: the top layer of cell-free plasma or PPP, the middle layer of PRF and the bottom layer, which are red blood cells, will be visible in the test tube. The middle layer, or PRF, is cut with scissors from the red blood cell clots and will be used randomly with biomaterials on one side of the sinus space.
Category
Treatment - Surgery
2
Description
Control group: This study is performed as a split mouth, ie in each patient, one side of the sinus lift surgery is performed with PRF intervention and is classified as an intervention group, and on the opposite side, sinus lift surgery without PRF intervention is performed as a control group.In each patient, there is both an intervention group and a control group. On one side of the mouth, which uses PRF, it is placed in the intervention group, and on the opposite side of the mouth, which does not use PRF, it is classified in the control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشکده دندانپزشکی آزاد واحد تبریز
Full name of responsible person
دکتر علی حسین دهقانی
Street address
Faculty of Dentistry.No. 2 of Islamic Azad University, Tabriz Branch. First Basmanj Road.Ahar Intersection.
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3637 6360
Email
dr.a.dehghani@iaut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ehsan hashemi
Street address
Faculty of Dentistry. Complex No. 2 of Islamic Azad University, Tabriz Branch.First Basmanj Road.Ahar Intersection
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3637 6360
Email
ranakhalafy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Rana khalafi
Position
General Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 143. Beheshti Deadend. Gajar Alley.Hojjati street
City
Tabriz
Province
East Azarbaijan
Postal code
5185737418
Phone
+98 41 3281 7829
Email
ranakhalafy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rana Khalafi
Position
General Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 143. Beheshti Dead end. Gajar Alley. Hojjati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5185737418
Phone
+98 41 3281 7829
Email
ranakhakafy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rana Khalafi
Position
General Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 143. Beheshti Dead end. Gajar Alley. Hojjati street
City
Tabriz
Province
East Azarbaijan
Postal code
5185737418
Phone
+98 41 3281 7829
Email
ranakhalafy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information. "
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