A comparison of osteobiol gen_os with normal healing extraction socket in quality and quantity of bone formation for implant placement in partial edentulous patients
The aim of this research is to evaluate a kind of bone material xenograft (ostel biol gen_os)in socket regeneration.patients need to extract two teeth in two contra-lateral quadrant.they have not systemic disease like Diabetes,Autoimmune disorder,viral and bacterial infection.they are not smokers and their cooporation is good.this is a randomized clinical trial study.12 cases(6 test and 6 control in 6 patients) were selected.after tooth removal the grafting material put in the socket.3 to 4 month later during implant placement,the speciment from both sites are sent for histologic and histomorphometric evaluation.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201202018898N1
Registration date:2012-07-25, 1391/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Mojgan Paknejad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5801
Email address
mpaknejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental Research Center, Tehran University of Medical Science
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of osteobiol gen_os with normal healing extraction socket in quality and quantity of bone formation for implant placement in partial edentulous patients
Public title
effect of osteobiol gen_os in healin process of socket
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:prescence of two hopeless teeth in two quadrant of the jaw
exclusion criteria: systemic disease such as diabetes,autoimmune disorder,viral and bacterial infection;smoker;patients with poor compliance and poor oral hygiene
;metabolic disorder that affected bone
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
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
Faculty of Dentistry,Tehran University of Medical Science
Street address
Faculty of Dentistry,Tehran University of Medical Science,Karegar Shomali St,Hakim Hwy,Tehran,IRAN
City
Tehran
Postal code
55991_14399
Approval date
2006-12-23, 1385/10/02
Ethics committee reference number
8601694798
Health conditions studied
1
Description of health condition studied
extraction of teeth due to periodontitis
ICD-10 code
K05,K08
ICD-10 code description
k 05:Gingivitis and periodontal diseases,k 08:Other disorders of teeth and supporting structures
Primary outcomes
1
Description
percantage of regenerative bone
Timepoint
4 month after extraction
Method of measurement
estimation of bone filled surface with photoshop software
2
Description
type of regenerating bone
Timepoint
4 month after extraction
Method of measurement
light microscope
3
Description
percentage fo remaining material
Timepoint
4 month after extraction
Method of measurement
evaluation of material filled surface with photoshop software
Secondary outcomes
1
Description
bone vitality
Timepoint
4 month after extraction
Method of measurement
light microscope
2
Description
foregin body reaction
Timepoint
4 month after extraction
Method of measurement
light microscope
3
Description
inflamation
Timepoint
4 month after extraction
Method of measurement
number of inflamatory cells in high power field
Intervention groups
1
Description
putting bone graft in socket and sampling during implamentation surgery
Category
Treatment - Surgery
2
Description
control group:no intervention after extraction and sampling during implamentation surgery
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology Center,Faculty of Dentistry,Tehran University of Medical Science
Full name of responsible person
Mojgan Paknejad
Street address
Faculty of Dentistry,Tehran University of Medical Science,Karegar Shomali St,Hakim Hwy,Tehran,IRAN
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Research Center,Tehran Univercity of Medical Science
Full name of responsible person
Elahe Alamdar
Street address
Tehran University of Medical Science, Ghods St,Enghelab Ave,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Center,Tehran Univercity of Medical Science
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
Faculty of Dentistry,Tehran University of Medical Science
Full name of responsible person
Mohadeseh Heidari
Position
Resident of Periodontology
Other areas of specialty/work
Street address
Faculty of Dentistry,Tehran University of Medical Science,Karegar Shomali St,Hakim Hwy,Tehran,IRAN
City
Tehran
Postal code
14399_55991
Phone
+98 21 8835 1168
Fax
Email
heidari_mohadeseh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry,Tehran University of Medical Science
Full name of responsible person
Mojgan Paknejad
Position
Profesor assistant,Peridontologist
Other areas of specialty/work
Street address
Faculty of Dentistry,Tehran University of Medical Science,Karegar Shomali St,Hakim Hwy,Tehran,IRAN
City
Tehran
Postal code
14399_55991
Phone
+98 88497390
Fax
Email
heidari_mohadeseh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry,Tehran University of Medical Science
Full name of responsible person
Mohadeseh Heidari
Position
Resident of Periodontology
Other areas of specialty/work
Street address
Faculty of Dentistry,Tehran University of Medical Science,Karegar Shomali St,Hakim Hwy,Tehran,IRAN
City
Tehran
Postal code
1439955991
Phone
+98 21 8835 1168
Fax
Email
heidari_mohadeseh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)