To determine the implant stability with and without platelet-rich fibrin among smokers
Design
This is a randomized clinical trial, phase II, in which 30 eligible smokers will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible smokers who will refer to School of Dentistry of Hamadan University during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 60 years;
Smoker;
Having at least 2 teeth lost;
Enough remaining bone volume for receiving implant with at least diameter of 4 mm and length of 11.5 mm;
Exclusion criteria:
Any lesion in oral cavity;
Using immunosuppressive drugs;
Using alcohol;
Liver, blood, or renal diseases;
Pregnancy
Intervention groups
Intervention group: The implant with at least diameter of 4 mm and length of 11.5 mm with platelet-rich fibrin
Control group: The implant with at least diameter of 4 mm and length of 11.5 mm without platelet-rich fibrin
Main outcome variables
Primary outcome: Implant stability immediately after surgery and 1 and 4 weeks after that through physical examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N211
Registration date:2018-03-12, 1396/12/21
Registration timing:registered_while_recruiting
Last update:2018-03-12, 1396/12/21
Update count:0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implant stability with and without platelet-rich fibrin among smokers: a randomized clinical trial
Public title
Implant stability with and without platelet-rich fibrin among smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 60 years
Smoker
Having at least 2 teeth lost
Enough remaining bone volume for receiving implant with at least diameter of 4 mm and length of 11.5 mm
Exclusion criteria:
Any lesion in oral cavity
Using immunosuppressive drugs
Using alcohol
Liver, blood, or renal diseases
Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
30
Two teeth loss in every patient will be randomly assigned to each implant. In other words, each patient will be its own control.
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through tossing coin
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
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.UMSHA.REC.1396.717
Health conditions studied
1
Description of health condition studied
Implant stability
ICD-10 code
M27.6
ICD-10 code description
Endosseous dental implant failure
Primary outcomes
1
Description
Implant stability
Timepoint
Immediately after surgery and 1 and 4 weeks after that
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The implant with at least diameter of 4 mm and length of 11.5 mm with platelet-rich fibrin
Category
Treatment - Devices
2
Description
Control group: The implant with at least diameter of 4 mm and length of 11.5 mm without platelet-rich fibrin
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Sara Ebrahimi
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sara_ebrahimi64@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Ebrahimi
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sara_ebrahimi64@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
Sara Ebrahimi
Position
Student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sara_ebrahimi64@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Ebrahimi
Position
Student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sara_ebrahimi64@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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