The purpose of this study was to evaluate the effect of PRF on bone height and bone density formed in sinus lift surgery and simultaneous insertion of dental implants.
Design
Clinical trial with blinded postoperative care and outcome assessment, split mouth
Settings and conduct
In this study, 14 patients were selected in 30-80 age with bilaterally partial or complete edentulous that referred to Dental School of Tabriz for sinus lift surgery and after receiving the written consent will enter to this study. Patients will be treated with Lateral window sinus lift technique.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The existence of bilaterally partial edentulous or complete edentulous in maxillary posterior region.
Height of the remaining bone between the floor of sinus and alveolar crest be more than 4mm and less than 8 mm.
Exclusion criteria:
Smokers-pregnant women- pathological symptoms or cystic lesions in the sinus- acute and chronic inflammatory disease of sinus- benign and malignant tumors in sinus-systemic diseases such as uncontrolled diabetes- cardiovascular diseases -cancer- head and neck radiotherapy- autoimmune diseases that makes trouble, healing of soft and hard tissue- taking steroidal drugs, immune system suppression and bisphosphonates- the existence of untreated periodontal disease and priapical disease, especially in the adjacent teeth of sinus floor.
Intervention groups
The sinus floor of test group will be augmented with lateral window sinus lift surgical technique with using PFR and simultaneously implantation
and in the control group, this process will be done without using the PRF.
Main outcome variables
Evaluation density and height of newly formed bone in the maxillary sinus by using of CBCT.
General information
Reason for update
Acronym
PRF (Platelet Rich Fibrin)
IRCT registration information
IRCT registration number:IRCT20120702010155N4
Registration date:2018-03-29, 1397/01/09
Registration timing:registered_while_recruiting
Last update:2018-03-29, 1397/01/09
Update count:0
Registration date
2018-03-29, 1397/01/09
Registrant information
Name
Mohammad Taghi Chitsazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
chitsazm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-01, 1396/12/10
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiographic comparison of density and height of posterior of maxillary bone after use of open sinus lift with and without PRF
Public title
Effect of PRF on bone density
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The existence of bilaterally partial edentulous or complete edentulous in maxillary posterior region
Height of the remaining bone between the floor of sinus and alveolar crest be more than 4 mm and less than 8 mm
Exclusion criteria:
Smokers- Pregnant women- Pathological symptoms or cystic lesions in the sinus - Acute and chronic inflammatory disease of sinus- Benign and malignant tumors in sinus- Systemic diseases such as uncontrolled diabetes- Cardiovascular diseases- Cancer- Head and neck radiotherapy- Autoimmune diseases that makes trouble, healing of soft and hard tissue- Taking steroidal drugs, immune system suppression and bisphosphonates- The existence of untreated periodontal disease and priapical disease, especially in the adjacent teeth of sinus floor.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
14
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient, one side of the sinus was considered as the test group and the other side was considered as the control group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patient and the investigator are aware of the study groups but a person who will evaluate the results of sinus graft surgery through CBCT radiography and the person who will analyze the results , there are no information from test and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Tabriz University of Medical Sciences
Street address
Ethics Committe of Tabriz University of Medical Sciences, Vice Chancllor for Research of Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Golghasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614713
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.TBZMED.REC.1396.1141
Health conditions studied
1
Description of health condition studied
Resorption of alveolar ridge in the maxillary posterior region
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Evaluation density and height of the newly formed bone.
Timepoint
4 months after surgery
Method of measurement
By CBCT and NNT viewer software version21
Secondary outcomes
empty
Intervention groups
1
Description
The sinus floor of intervention group will be augmented with lateral window sinus lift technique and using PFR and simultaneously implantation.
Category
Treatment - Surgery
2
Description
The sinus floor of control group will be augmented with lateral window sinus lift technique without PRF and simultaneously implantation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Taghi Chitsazi
Street address
Dental Faculty of Tabriz University of Medical Sciences, Golghasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5968
Email
chitsazm@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gingival and Dental Research Center of Tabriz Faculty of Dentistry
Full name of responsible person
Dr Shahriar Shahi
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5968
Email
chitsazm@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gingival and Dental Research Center of Tabriz Faculty of Dentistry
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
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Kokabi Arasteh
Position
Resident of Periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Periodontics., Dental Faculty., Tabriz University of Medical Sciences., Golghasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5968
Fax
Email
kokabih@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Taghi Chitsazi
Position
Professor
Latest degree
Master
Other areas of specialty/work
periodontology
Street address
Department of Periodontics., Dental Faculty., Tabriz University of Medical Sciences., Golghasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
Email
chitsazm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Kokabi Arasteh
Position
Resident of Periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Periodontics., Dental Faculty., Tabriz University of Medical Sciences., Golghasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5968
Fax
Email
kokabih@tbzmed.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