The effect of window dimension and membrane usage on lateral sinus membrane elevation and soft tissue invasion to sinus cavity
Design
Study groups:
Group 1: Conventional sinus lift patients (window size 7-8 mm) without membranes
Group 2: Conventional sinus lift patients with absorbable membranes
Group 3 :: Sinus lift patients with small window dimensions (Windows 5-4 mm) without membranes
Group 4: Small-sized sinus lift patients with absorbent membranes
Randomization based on the table of numbers and sample size in a total of 16 patients in each group of 4 patients
Settings and conduct
Surgery is performed in the Department of Oral and Maxillofacial Surgery, School of Dentistry, Ahvaz Jundishapur University of Medical Sciences, and the Surgery Center of the Surgeon.
Participants/Inclusion and exclusion criteria
Patients with alveolar ridge atrophy in posterior of maxilla (Class I, II, II, Kennedy)
The height of the remaining ridge should be between 3-5 mm
Patients without uncontrolled systemic disorder
Patients who do not use factors that affect healing, such as cigarettes
Patients who need to raise the sinus membrane more than 4 mm
Intervention groups
Patients with the need for sinus lift surgery to place the implant by a skilled surgeon, the surgery is determined according to the random table according to the patients' visit, the dimensions of the window and the window is created in the dimensions of 4-5 or 7-8 mm. The sinus membrane is given with very small sinus alluvium and the use of high sense tactile and allograft size 2000-1000 graft is placed in the area. Membranes are randomly placed on the window.
Main outcome variables
Creating a suitable bone around the implant with different surgical methods
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049312N1
Registration date:2020-11-29, 1399/09/09
Registration timing:prospective
Last update:2020-11-29, 1399/09/09
Update count:0
Registration date
2020-11-29, 1399/09/09
Registrant information
Name
ehsan mostajeran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3771 2831
Email address
mostajeran.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-01, 1399/10/12
Expected recruitment end date
2021-03-01, 1399/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of window dimension and membrane usage on lateral sinus membrane elevation and soft tissue invasion to sinus cavity
Public title
the effect of window dimension on sinus lift successful rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
alveolar ridge atrophy in posterior of maxilla
remaining alveolar ridge between 3-5 millimeter
the patient without any uncontrol disorder, immunosuppress, physical disorder, bisphosphonate drug usage, chemotherapy and radiotherapy on face area
the patient who don't smoking
the patient who need sinus membrane elevation more than 4 milliliter
Exclusion criteria:
the patient with uncontrol disorder, and some disease like: immunosuppress, physical disorder, bisphosphonate drug usage, chemotherapy and radiotherapy on face area
remaining alveolar ridge more than 5 millimeter
the patient who need sinus membrane elevation less than 4 milliliter
the smoker patient
patient with acute sinusitis
Age
From 25 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Since patients will be candidates for surgery based on referral and it is not possible to access them together at the same time, sampling will be sequential to complete the number of samples. The initial evaluator, if the input criterion is met without knowing the type of surgical technique that will be performed, randomly allocates the patient to a study group using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
It should be noted that the patient and the evaluator (clinical and radiological evaluation) are not aware of the type of window and whether or not to place the membranes. Of course, the patient is fully aware of the surgery and its purpose and the 4 types of techniques that can be performed, but will not know in which group it is located. The initial and final assessor will also be generally unaware of what technique has been applied to each patient
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of ahvaz university of medical sciences
Street address
No. 119, Mohammadi Alley, Attari Ave, Sharifzade Ave, 24 metri azadegan street
City
ahvaz
Province
Khouzestan
Postal code
6193654589
Approval date
2020-10-09, 1399/07/18
Ethics committee reference number
IR.AJUMS.REC.1399.550
Health conditions studied
1
Description of health condition studied
atrophy of maxillary alveolar ridge posteriorly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
elevation the sinus membrane
Timepoint
Obtaining CBCT after five months after surgery
Method of measurement
Use CBCT radiography
Secondary outcomes
1
Description
Complications during and after surgery, pain and patient comfort
Timepoint
From the time of surgery until a week later
Method of measurement
interview with patients and observation of complications
Intervention groups
1
Description
Control group: Group 1 : Patients who perform conventional sinus lift (window size 7-8 mm) without membranes
Category
Treatment - Surgery
2
Description
Intervention group: Group 2: Patients who perform conventional sinus lift with absorbent membranes.
Category
Treatment - Surgery
3
Description
Intervention group: Group 3: Patients Perform small sine lift windows (windows 5-4 mm) without membranes.
Category
Treatment - Surgery
4
Description
Intervention group: Group 4: Patients who perform small sine lift windows with absorbent membranes.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral and Maxillofacial Surgery, School of Dentistry, Ahvaz Jundishapur University of M
Full name of responsible person
kazem khiabani savojbolaghchi
Street address
No. 119, Mohammadi Alley, Attari Ave, Sharifzade Ave, 24 metri azadegan street
City
ahvaz
Province
Khouzestan
Postal code
6193654589
Phone
+98 31 3771 2831
Email
mostajeran.e@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
kazem khiabani savojbolaghchi
Street address
ahvaz jondishapur university of medical science
City
ahvaz
Province
Khouzestan
Postal code
61355715794
Phone
+98 31 3771 2831
Email
mostajeran.e@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
ehsan mostajeran
Position
oral and maxillofacial surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 119, Mohammadi Alley, Attari Ave, Sharifzade Ave, 24 metri azadegan street
City
ahvaz
Province
Khouzestan
Postal code
6193654589
Phone
+98 31 3771 2831
Email
mostajeran.e@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
kazem khiabani savojbolaghchi
Position
associate professor of oral and maxillofacial surgery
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department of dental faculty of ahvaz jondishapor medical science university
City
ahvaz
Province
Khouzestan
Postal code
61357115794
Phone
+98 61 3320 5168
Email
khiabani_ak@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
kazem khiabani savojbolaghchi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department of dental faculty of ahvaz jondishapor medical science university
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3320 5168
Email
khiabani_ak@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
the data is related to the amount of elevation of the sinus membrane and the surrounding bone around the implant in different sizes of the lateral window with or without the use of membranes.
When the data will become available and for how long
starting patient surgery at 1 january 2021 till 1march 2021
To whom data/document is available
open access in public
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Send a message to the email of the corresponding author
What processes are involved for a request to access data/document