The purpose of this study is to compare implant stability and crestal bone loss around implant in Dio-SM & Dentis implants from implant insertion to third month. Methods: A total of 30 implants (15 implants from each system) were placed. Dio-SM implants were placed bilaterally symmetrical or beside Dentis S-clean implants. After to connect healing abutment, implant stability was recorded by PERIOTEST and parallel standard radiography was done at baseline, the first month and third month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011411560N2
Registration date:2013-02-01, 1391/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-01, 1391/11/13
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Khorasgan Branch, Dental School of Azad University
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Crestal bone loss and Implant stability between Dio and Dentis Implants
Public title
Comparison of Crestal bone loss and Implant stability between Dio and Dentis Implants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 65-20 years; 25% or less plaque before surgery; two adjacent edentulous area or bilaterally symmetrical, with identical conditions to put implants with same length and diameter (± 0.2) in a patient; good bone height and width. Exclusion criteria: presence of systemic disease; smoking; infection with other types of periodontitis except chronic periodontitis, implant placement in fresh socket; additional surgeries such as bone grafting.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the Medical Sciences, khorasegan part, Islamic Azad University
Street address
University Boulevard, Arghavanieh, East J Street
City
Esfahan
Postal code
81551-39998
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1207549
Health conditions studied
1
Description of health condition studied
Dental Implant
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
implant stability
Timepoint
base line, the first month, third month
Method of measurement
Priotest device
2
Description
crestal bone loss
Timepoint
at base line, the first month, third month
Method of measurement
standard radiography
Secondary outcomes
empty
Intervention groups
1
Description
Dio implant placement
Category
Treatment - Surgery
2
Description
Dentis implant placement
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Khorasgan Branch, Islamic Azad University of Isfahan
Full name of responsible person
Deputy of Research
Street address
University Boulevard, Arghavanieh, East J Street
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khorasgan Branch, Islamic Azad University of Isfahan
Full name of responsible person
Deputy of Research, Dr. Paiam Najafi
Street address
University Boulevard, Arghavanieh, East J Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khorasgan Branch, Islamic Azad University of Isfahan
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
khorasgan Branch, Islamic Azad University of Isfahan
Full name of responsible person
Dr. Paiam Najafi
Position
Deputy of Research
Other areas of specialty/work
Street address
University Boulevard, Arghavanieh, East J Street
City
Isfahan
Postal code
8155139998
Phone
+98 31 1535 4001
Fax
+98 31 1535 4001
Email
payam.najafi@gmail.com
Web page address
http://www.khuisf.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
khorasgan Branch, Islamic Azad University of Isfahan
Full name of responsible person
Seeid Hedayat-allah Golestaneh
Position
Periodontologist
Other areas of specialty/work
Street address
University Boulevard, Arghavanieh, East J Street
City
Isfahan
Postal code
8155139998
Phone
+98 31 1535 4001
Fax
+98 31 1535 4001
Email
golestaneh@dnt.mui.ac.ir
Web page address
http://www.khuisf.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
khorasgan Branch, Islamic Azad University of Isfahan
Full name of responsible person
Abdosafah Sherafati
Position
Dentist
Other areas of specialty/work
Street address
unit 2,number 10, 37 Avenue, Nasr Koye
City
Tehran
Postal code
25456-542312
Phone
+98 21 8826 0550
Fax
Email
slr_1975@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)