To compare the success rate of immediate versus delayed implant placement in patients who need implant
Design
This is a randomized clinical trial, phase II, in which 50 eligible patients will be randomly assigned to the intervention (immediate implant placement) and control (delayed implant placement) groups
Settings and conduct
The eligible patients who need implant and will refer to School of Dentistry during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Need implant
Exclusion criteria:
Tooth and gum infection
Intervention groups
Intervention group: Immediate implant placement immediately after tooth extraction without using bone marrow material
Control group: Delayed implant placement one month after tooth extraction without using bone marrow material
Main outcome variables
Primary outcome: Assessing clinical success of implant one year after surgery through clinical examination and radiography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N207
Registration date:2018-02-19, 1396/11/30
Registration timing:retrospective
Last update:2018-02-19, 1396/11/30
Update count:0
Registration date
2018-02-19, 1396/11/30
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
2016-12-30, 1395/10/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of immediate versus delayed implant placement in patients who need implant: a randomized clinical trial
Public title
Comparison of the success rate of immediate versus delayed implant placement in patients who need implant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Need implant
Exclusion criteria:
Tooth and gum infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
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
2016-12-24, 1395/10/04
Ethics committee reference number
IR.UMSHA.REC.1395.427
Health conditions studied
1
Description of health condition studied
The failure or success of implant placement
ICD-10 code
M27.6
ICD-10 code description
Endosseous dental implant failure
Primary outcomes
1
Description
Assessing clinical success of implant
Timepoint
One year after surgery
Method of measurement
Through clinical examination and radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Immediate implant placement immediately after tooth extraction without using bone marrow material
Category
Treatment - Surgery
2
Description
Control group: Delayed implant placement one month after tooth extraction without using bone marrow material
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Koorosh Tamizi
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
offecpring_k@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
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
Koorosh Tamizi
Position
Dental Student
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
offecpring_k@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Parviz Torkzaban
Position
Periodontist
Latest degree
Specialist
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
torkzaban_m@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