Comparison the effect of bone platform-switched and non platform-switched implants on marginal bone loss after 12 months of follow up in patients under implant treatment: A randomized clinical trial
The aim of the study: Comparison the effect of bone platform-switched and non platform-switched implants placed in patients who need implant treatment on marginal bone loss after 12 months of follow up
Design: A unicentral randomize clinical trial.
Sample size: A number of 25 non platform-switched implants will be examined as a control group and the same number of platform-switched implants will be assessed as a test group.
Inclusion criteria: patients who need implant treatment in premolar and molar regions and also have the essential systemic and local conditions for the implant placement surgery will be registered in the study.
Exclusion criteria: Patients who are unwilling to continue the study will be excluded.
Intervention: Bone level implant placement.
Outcome: Determination of the amount of marginal bone loss, 12 month after the implant placements.
After an 8-week healing period the implant supported crown will be formed. During the follow-up period, 12 months after implant placements, a periapical digital radiography will be recorded from both the test and the control groups and the amount of crestal bone loss will be measured and will be compared between groups.
All implants will be of the same brand with the same surface texture.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204029358N1
Registration date:2012-11-02, 1391/08/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-02, 1391/08/12
Registrant information
Name
Amirreza Rokn
Name of organization / entity
Dental Implant Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8351
Email address
roknamir@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Granted by Tehran University of Medical Sciences.
Expected recruitment start date
2012-10-27, 1391/08/06
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of bone platform-switched and non platform-switched implants on marginal bone loss after 12 months of follow up in patients under implant treatment: A randomized clinical trial
Public title
The effect of bone platform switched implants on marginal bone loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who need implant treatment in premolar and molar regions and also have the essential systemic and local conditions for the implant placement surgery will be registered in this study.
Exclusion criteria: Patients who are unwilling to continue the study will be excluded.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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
Tehran University of Medical Sciences
Street address
Ghods building, Bolvar Keshavarz Ave.
City
Tehran
Postal code
Approval date
2012-10-06, 1391/07/15
Ethics committee reference number
63883
Health conditions studied
1
Description of health condition studied
Other disorders of teeth and supporting structures
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Marginal bone loss
Timepoint
12 month afterthe intervention
Method of measurement
Periapical digital radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Application of platform switching technique for implant treatment in premolar and molar regions of the mouth. In this group Noble active implants will be applied.
Category
Treatment - Other
2
Description
Control: Application of non-platform switching technique for implant treatment in premolar and molar regions of the mouth. In this group Noble Biocare Replace Select Groovy implants wiil be applied
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Implant ward of dental school, Tehran University of Medical Sciences
Full name of responsible person
Amirreza Rokn
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Ghods building, Bolvar Keshavarz Ave.
City
Tehran
Grant name
Grant code / Reference number
91-01-104-17105
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental Implant Research Center, Tehran University of Medical Sciences
Full name of responsible person
Shadab Rashtak
Position
Dentist
Other areas of specialty/work
Street address
Dental Implant Research Center, Tehran University of Medical Sciences, Ghods st., Bolvar Keshavarz Ave.
City
Tehran
Postal code
Phone
+98 21 8897 8351
Fax
Email
shadab.rashtak@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Implant Research Center, Tehran University of Medical Sciences
Full name of responsible person
Amirreza Rokn
Position
DDS,MSc, Associated Prof
Other areas of specialty/work
Street address
Dental Implant Research Center, Tehran University of Medical Sciences, Ghods st., Bolvar Keshavarz Ave.
City
Tehran
Postal code
Phone
+98 21 8897 8351
Fax
Email
arrokn@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Implant Research Center, Tehran University of Medical Sciences
Full name of responsible person
Rebecca Menasheof
Position
Dentist
Other areas of specialty/work
Street address
Dental Implant Research Center, Tehran University of Medical Sciences, Ghods st., Bolvar Keshavarz Ave.
City
Tehran
Postal code
Phone
+98 21 8897 8351
Fax
Email
rebecca.menasheof@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)