Comparison of bone formation in bilateral sinus lift with and without graft
Design
The study contains 10 patient whom referring to the oral and maxillofacial surgery ward , Babol University medical Science , which have complete or partial edentulous in posterior maxilla and they need bilateral open sinus lift augmentation. Patients will divide in two groups ;case and control. In control group open sinus lift is going to be done with bone material substitution ( 1cc) and in case group open sinus lift is going to be done alone without any bone substitute.Then Implants will insert . CBCT is taken before surgery and will take 1and 6 months after implants insertion and biopsy will take 6 months after implant insertion.
CBCTs will assess with a dental radiologist and biopsies will assess with a dental pathologist for configuration of new bone formation.
Settings and conduct
10 Patients whom need for bilateral open sinus lift refering to the Oral and Maxillofacial Surgery Ward , Babol university of medical science,will devided in 2 groups; case and control
Control group: patient who needs open sinus lift on one side with graft augmentation
Case group: the same patient in control group who need open sinus lift on the other side without graft augmentation
The study is a non randomized double blind one which the patients and the pathologist don't know anything about the side of the graft. We don't make radiologist informed either but due to the opacity of the graft he will understand the graft side himself.
Participants/Inclusion and exclusion criteria
Patients who need bilateral open sinus lift with implant insertion
Patients should be medically healthy and without any systemic or metabolic disease
Accept the prosthetic treatment plan
Accept to sign the consent
Intervention groups
Case groups are patients who need maxillary open sinus lift - without graft
Control groups are the same patients whom need maxillary open sinus lift on the other side - with bone graft
Main outcome variables
evaluation of surgical time ; evaluation of cost ; evaluation of complications due to grafting as infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036780N4
Registration date:2018-03-11, 1396/12/20
Registration timing:registered_while_recruiting
Last update:2018-03-11, 1396/12/20
Update count:0
Registration date
2018-03-11, 1396/12/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11321995926
Email address
z.malekpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bone formation in bilateral sinus lift with and without graft
Public title
Comparison of bone formation in bilateral sinus lift with and without graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not medically compromised
Bilateral complete or partial edentulous in maxilla
Bilateral open sinus lift
Bone height in alveolar crestal ridge in sinus lift area must be at least 4 mm
Exclusion criteria:
History of having systemic or local disease such as bone metabolic disorder
Do not accept prosthetic treatment plan
Do not sign the consent
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
biopsy will take from both side by 3mm Trephine Burr and we use bone materials to fill the defect.
Randomization (investigator's opinion)
Not randomized
Randomization description
Individual Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Making pathologist blind by sending unknown specimen to laboratory
Two treatment plans was explained for the patient but the patient was not informed about the treatment plan on each side
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrouz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
MUBABOL.REC.1396.77
Health conditions studied
1
Description of health condition studied
dental implants
ICD-10 code
ICD-10 code description
2
Description of health condition studied
atrophic ridge of maxilla
ICD-10 code
ICD-10 code description
3
Description of health condition studied
New bone formation in sinus lift procedure
ICD-10 code
ICD-10 code description
4
Description of health condition studied
open sinus lift
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quantity and quality of new bone formation
Timepoint
1 and 6 months after implant insertion
Method of measurement
CBCT and microscopic analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group open sinus lift is going to be done alone without any bone material
Category
Treatment - Surgery
2
Description
Control group: In control group sinus lift is going to be done with bone material substitution ( 1cc, xenograft) as a usual procedure in sinus lift
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Science,School of dentistry
Full name of responsible person
Zahra Malekpour Ghorbani
Street address
Babol University of Medical Science,School of dentistry
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
zahedpasha_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganjafruz street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 4718
Email
info.research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Amir Zahedpasha
Position
Resident of Maxillofacial Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganjafruz street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
zahedpasha_amir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Malekpour Ghorbani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial surgery
Street address
Ganjafrouz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
z.malekpour@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol university of medical science,dentistry faculty
Full name of responsible person
Amir Zahedpasha
Position
Resident of maxillofacial surgry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganjafruz street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
zahedpasha_amir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data allowed to be shared
When the data will become available and for how long
Since 2018
To whom data/document is available
all researchers
Under which criteria data/document could be used
all
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
After making contact with general responsible person