Comparison of guided bone regeneration of collagen-curcumin-aspirin membrane with commercial collagen membrane in patients who needed alveolar ridge augmentation for implant placement
Comparison of guided bone regeneration of collagen-curcumin-aspirin membrane with commercial collagen membrane in patients who needed alveolar ridge augmentation for implant placement
Design
A parallel clinical trial with the control group of 10 patients
Settings and conduct
The prepared membranes will be used in 10 patients (each patient needs two implants). After implant placement, the periosteum and skin are sutured using a 5-0 suture. In 1, 2, 4 and 8 weeks after surgery, a clinical evaluation of the paitient will be performed. In two month after surgery, the radiographic images will be used to examine the area.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who need implant placement and alveolar ridge augmentation at the same time.
Exclusion criteria: People with poor oral health
Intervention groups
Test group: The prepared collagen-curcumin-aspirin membranes are used under the implant.
Control group: Commercial collagen membranes are used under the implant.
Main outcome variables
Ability to conduct guided bone regeneration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048756N2
Registration date:2021-01-20, 1399/11/01
Registration timing:prospective
Last update:2021-01-20, 1399/11/01
Update count:0
Registration date
2021-01-20, 1399/11/01
Registrant information
Name
Solmaz Maleki Dizaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 3161
Email address
maleki.s.89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-02, 1399/11/14
Expected recruitment end date
2021-03-04, 1399/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of guided bone regeneration of collagen-curcumin-aspirin membrane with commercial collagen membrane in patients who needed alveolar ridge augmentation for implant placement
Public title
Evaluation of guided bone regeneration in collagen-curcumin-aspirin membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need implant placement and alveolar ridge augmentation at the same time.
Exclusion criteria:
People with poor oral health
Smokers
Alcoholics
People with diabetes
People with high blood pressure or other systemic diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
-
Randomization (investigator's opinion)
N/A
Randomization description
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 Tabriz University of Medical Sciences
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.TBZMED.REC.1399.864
Health conditions studied
1
Description of health condition studied
Guided bone regeneration (GBR) to improve bone defects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
New bone formation
Timepoint
Two months after implant and membrane placement
Method of measurement
Radiographic imaging
Secondary outcomes
empty
Intervention groups
1
Description
Control group: One of the patient's implants is considered as a control in which a commercial collagen membrane (Regen, Germany) is placed in the lower tissue of the implant and then the tissue is sutured and the implant is placed. Another implant of the patient is considered as the test group. Collagen-curcumin-aspirin membranes are placed in the lower tissue of the implant and then the tissue is sutured and the implant is placed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Amir Hossein Bani Shahabadi
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
a_banishahabadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
Street address
Golgasht St, Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Vice Chancellor for Research and Technology
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Amir Hossein Bani Shahabadi
Position
Resident of Oral and Maxillofacial Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
a_banishahabadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be published as an article.
When the data will become available and for how long
After the final publication of the article resulting from the data.
To whom data/document is available
Public
Under which criteria data/document could be used
For use in research articles and systematic reviews with citation.
From where data/document is obtainable
Dr. Solmaz Maleki Dizaj, Tabriz Faculty of Dentistry
What processes are involved for a request to access data/document