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Evaluation of the success of surgical guide in maxillary sinus lifting surgery

Protocol summary

Study aim
Determining the success rate of using a digital surgical guide in maxillary sinus lift surgery
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, on 10 patients. Envelope shuffle method was used for randomization.
Settings and conduct
This study is carried out in the university dental clinic of Hamedan University of Medical Sciences and the crust incision is made together with the free incision in the anterior region and the complete mucoperiosteal flap is lifted. Using a round 02 reamer, a 5x5 mm window is installed in the surgical area and in the sinus wall, and the sinus membrane is slowly lifted and pushed aside. The Xenoben Alu Graft, a Kish Baft product, is then used to fill the desired space.
Participants/Inclusion and exclusion criteria
Inclusion criteria: applicants for sinus floor elevation surgery in the area of the first premolar to the first molar of the upper jaw. Exclusion criteria: smoking, history of surgery in this area
Intervention groups
In the test group, first, the anesthetic lidocaine with epinephrine 1:800000 (Perzocaine - Daropakhsh Iran) is injected by the infiltration method behind the upper jaw and the palatal region. After achieving complete anesthesia in this area, the crust incision is made together with the free incision in the anterior region and the complete mucoperiosteal flap is lifted. Using a round 02 reamer, a 5x5 mm window is installed in the surgical area and in the sinus wall, and the sinus membrane is slowly lifted and pushed aside. The Xenoben Alu Graft, a Kish Baft product, is then used to fill the desired space. There is no special intervention in the control group.
Main outcome variables
Elevation of the maxillary sinus floor in the area of the first premolar to the first molar of the upper jaw

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170117032025N12
Registration date: 2024-03-10, 1402/12/20
Registration timing: prospective

Last update: 2024-03-10, 1402/12/20
Update count: 0
Registration date
2024-03-10, 1402/12/20
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
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the success of surgical guide in maxillary sinus lifting surgery
Public title
The success of surgical guide in maxillary sinus lifting surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Applicant for sinus floor lifting surgery in the area of the first premolar to the first molar of the upper jaw
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
2022-12-24, 1401/10/03
Ethics committee reference number
IR.UMSHA.REC.1401.835

Health conditions studied

1

Description of health condition studied
Elevation of the maxillary sinus floor in the area of the first premolar to the first molar of the upper jaw
ICD-10 code
M26.02
ICD-10 code description
Maxillary hypoplasia

Primary outcomes

1

Description
Elevation of the maxillary sinus
Timepoint
6 months after surgery
Method of measurement
By Cone-Beam Computed Tomography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: first, the anesthetic lidocaine with epinephrine 1:800000 (Perzocaine - Daropakhsh Iran) is injected by the infiltration method behind the upper jaw and the palatal region. After achieving complete anesthesia in this area, the crust incision is made together with the free incision in the anterior region and the complete mucoperiosteal flap is lifted. Using a round 02 reamer, a 5x5 mm window is installed in the surgical area and in the sinus wall, and the sinus membrane is slowly lifted and pushed aside. The Xenoben Alu Graft, a Kish Baft product, is then used to fill the desired space.
Category
Treatment - Surgery

2

Description
Control group: There is no special 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 Sciencesو Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3525 0182
Email
dr.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
Subspecialist
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 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
Subspecialist
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 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
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Hamadan of University of Medical Sciences, Shahid Fahmideh boulvard
City
Faculty Member
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
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