Histomorphometric examination of sinus floor bone due to the use of foam Collagen compared to mineralized allografts for bone formation in Open sinus lifting without implant placement
Histomorphometric determination of sinus floor bone due to the use of collagen foam biomaterial in comparison with mineralized allograft for bone formation in the treatment of sinus lifting in patients referred to the School of Dentistry of Islamic Azad University of Tehran in 2021
Design
A non-randomized clinical trial with control group, with parallel groups, without blinding, on 20 patients.
Settings and conduct
The study site is the Department of Surgery, School of Dentistry, Islamic Azad University of Tehran; blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: with maxillary sinus floor bone less than 5 mm at the implant site.
Non-inclusion criteria: 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 without implant placement.
Control group: Use of mineralized allograft biomaterial as a graft in the treatment of open sinus lifting without implant placement
Main outcome variables
Percentage of ossification by immature and lamellar bones; Angiogenesis; The degree of inflammation and reaction of a foreign body; Percentage of material remaining
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210223050469N3
Registration date:2021-11-29, 1400/09/08
Registration timing:registered_while_recruiting
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
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
Histomorphometric examination of sinus floor bone due to the use of foam Collagen compared to mineralized allografts for bone formation in Open sinus lifting without implant placement
Public title
Using foam Collagen bone formation in Open sinus lifting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Has a maxillary sinus floor bone less than 5 mm at the implant site
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
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant and statistical analyst does not know which material will be used in each patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Azad University of Medical Sciences
Street address
No.9, 9th Neystan, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.284
Health conditions studied
1
Description of health condition studied
maxillary sinus floor pneumatization
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of ossification by immature, lamellar and necrotic bones
Timepoint
Four months later
Method of measurement
Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan
2
Description
Angiogenesis
Timepoint
Four months later
Method of measurement
Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan
3
Description
Extent of inflammation and foreign body reaction
Timepoint
Four months later
Method of measurement
Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan
4
Description
Percentage of material remaining
Timepoint
Four months later
Method of measurement
Histomofometric measurement of sinus floor bone with ys100 light microscope made in Japan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All surgeries are performed in two stages and in the first stage, include open sinus lift is performed using collagen foam bonding material made by Etticon company without implant placement. Then 6 months later, the second stage of surgery, which includes bone sampling with trephine in the bone drill site with implant placement
Category
Treatment - Surgery
2
Description
Control group: All surgeries are performed in two stages and in the first stage, include open sinus lift is performed using mineralized allograft bonding material made by Kish company without implant placement. Then 6 months later, the second stage of surgery, which includes bone sampling with trephine in the bone drill site with implant placement
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 street
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 street
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
Erfan Babaie
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neystan, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
erfan.babaie.mjrd@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 street
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
Erfan Babaie Mojarad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.9, 9th Neystan, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
erfan.babaie.mjrd@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