Determining the success rate of free buccal fat tissue in closing Schneider's membrane perforation in maxillary sinus lift surgery.
Design
A controlled, parallel-group, unblinded, randomized clinical trial on 10 patients. Computer randomization methods were used for randomization.
Settings and conduct
This study is carried out in the university dental clinic of Hamedan University of Medical Sciences and in the test group, the axilla is raised to a height of about 12 mm, and the perforation site is covered by Aluderm membrane with a thickness of 0.9 mm from Saz Ben Company. After that, the FDBA allograft material of the same company with a particle size of 1000 to 2000 is used with the product of the same company to fill the desired space.
Participants/Inclusion and exclusion criteria
Applicants for sinus floor lifting surgery in the area of the first premolar to the first molar of the upper jaw, Have perforations smaller than 5 mm in Schneider's membrane during treatment.
Intervention groups
In the test group, the membrane is raised to a height of about 12 mm and the perforation site is covered by Aluderm membrane with a thickness of 0.9 mm from Saz Ben Company. There is no special intervention in the control group.
Main outcome variables
Closing the perforation of Schneider's membrane
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032025N11
Registration date:2024-02-18, 1402/11/29
Registration timing:prospective
Last update:2024-02-18, 1402/11/29
Update count:0
Registration date
2024-02-18, 1402/11/29
Registrant information
Name
Arash Khalili
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
a.khalili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the success of free buccal fat pad in closure of membrane perforation in maxillary sinus lifting surgery
Public title
Evaluation of the success of free buccal fat pad in closure of membrane perforation in maxillary sinus lifting surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Applicants for sinus floor lifting surgery in the area of the first premolar to the first molar of the upper jaw
Have perforations smaller than 5 mm in Schneider's membrane during treatment
Exclusion criteria:
Smoking
History of surgery in this area
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, we use the envelope shuffling method and for this purpose, we prepare 10 sheets of paper including 5 intervention sheets (Word A) and another 5 sheets of the control group (Word B) without replacement by choosing the patient in one of them. The patients are placed in one of the two groups by their choice without replacement.
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 Hamadan University of Medical Sciences
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
7615665175
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.UMSHA.REC.1402.104
Health conditions studied
1
Description of health condition studied
Perforation of Schneider's membrane
ICD-10 code
M26.02
ICD-10 code description
Maxillary hypoplasia
Primary outcomes
1
Description
Full area coverage
Timepoint
6 months after surgery
Method of measurement
By Cone-Beam Computed Tomography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The axilla is raised to a height of about 12 mm, and the perforation site is covered by Aluderm membrane with a thickness of 0.9 mm from Replicator Ben Company. After that, the FDBA allograft material of the same company with a particle size of 1000 to 2000 is used with the product of the same company to fill the desired space.
Category
Treatment - Surgery
2
Description
Control group: There is no intervention in the control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic of Hamadan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
R_Shokohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan of University of Medical Sciencesو Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Heidari
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
aliheidari55@gmail.com
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