Determining the effect of using collagen foam biomaterial for bone formation in the treatment of sinus lifting by CBCT of patients referred to Islamic Azad University,Tehran Dental Branch in the 1400
Design
A clinical trial with control group,with parallel group,with blinding, with non-random for 12 patients.
Settings and conduct
The study site is the Department of Surgery, School of Dentistry, Islamic Azad University of Tehran; No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
En Inclusion criteria: with maxillary sinus floor bone less than 3 mm at the implant site Exclusion criteria: no systemic/infectious disease; smoking; Uncontrolled or poorly controlled diabetes; Use of immunosuppressive drugs; Bisphosphonate drugs; History of head and neck radiotherapy; Active maxillary sinus obstruction; Chronic steroid treatment
Intervention groups
Intervention group: Using collagen foam biomaterial as a bonding agent in the treatment of open sinus lifting
Control group:Use of mineralized allograft biomaterial as a graft in the treatment of open sinus lifting
Main outcome variables
Determining the amount of ossification done using CBCT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210223050469N4
Registration date:2021-12-04, 1400/09/13
Registration timing:registered_while_recruiting
Last update:2021-12-04, 1400/09/13
Update count:0
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Vahid Mesgarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8878 0179
Email address
vahid_mesgar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-27, 1400/09/06
Expected recruitment end date
2021-12-07, 1400/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using collagen foam biomaterial for bone formation in the treatment of open lifting sinus in CBCT images
Public title
Evaluation of the effect of using collagen foam biomaterial for bone formation in the treatment of open lifting sinus in CBCT images
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of maxillary sinus expansion through panoramic radiography and the need for sinus lifting treatment
Patients in the age range of 25 to 65 years
Exclusion criteria:
Presence of systemic /infectious disease
Smoking
Alcohol consumption
Uncontrolled or poorly controlled diabetes
Bruxism
Taking immunosuppressive drugs
Taking bisphosphonate drugs
History of head and neck radiotherapy
Active maxillary sinus disease
Chronic steroid treatment
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and the outcome evaluator and data analyst do not know the material used. In this way, only the respected surgeon who performs the surgery knows the material used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad University of Medical Sciences
Street address
No.9, 9th Neystan, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-08-05, 1399/05/15
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.165
Health conditions studied
1
Description of health condition studied
Evaluation of the effect of using collagen foam in ossification in open sinus lifting operation in comparison with allograft
ICD-10 code
K08.26
ICD-10 code description
Severe atrophy of the maxilla
Primary outcomes
1
Description
Quantity of sinus floor bone
Timepoint
6 months later
Method of measurement
Radiographic measurements by CBCT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before surgery, CBCT is taken of the desired area and with the software the vertical height of the bone is measured in the specified sections the open sinus lift is then performed using a collagen foam graft made by Etticon company.6 months later, CBCT is performed again and the vertical bone height is measured again in the same sections.
Category
Treatment - Surgery
2
Description
Control group: Before surgery, CBCT is taken of the desired area and with the software the vertical height of the bone is measured in the specified sections the open sinus lift is then performed using a mineralized allograft bonding material made by Kish company .6 months later, CBCT is performed again and the vertical bone height is measured again in the same sections.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Vahid Mesgarzadeh
Street address
No.9, 9th Neystan, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Vahid_mesgar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Arash Azizi
Street address
No.9, 9th Neystan, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Islamic Azad University, Tehran Dental Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Zahra Saeedi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neystan, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Z.saeediii159@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vahid Mesgarzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neystan, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Vahid_mesgar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Saeedi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neystan, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Z.saeediii159@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