This study is a single-blind controlled clinical trial. A total of 24 one-stage implants in mandible of 12 patients in a splith mouth design are placed. on all implants, gingival former were placed . both implants in each patient have the same diameter and length .one implant in each patient before insertion , (test group). Implant stability measured with periotest unit on all implanton the day of surgery and weeks 1,2,4, 6 and 8 after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104116166N1
Registration date:2011-11-21, 1390/08/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-21, 1390/08/30
Registrant information
Name
Narges Fahami
Name of organization / entity
Islamic Azad University of Isfahan(Khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
n.fahami@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Khorasgan branch
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Platelet-Rich Plasma on Implant Stability in Mandible
Public title
Effect of Platelet-Rich Plasma on Implant Stability in Mandible
Effect of Platelet-Rich Plasma on Implant Stability in Mandible
Effect of Platelet-Rich Plasma on Implant Stability in Mandible
Effect of Platelet-Rich Plasma on Implant Stability in Mandible
Effect of Platelet-Rich Plasma on Implant Stability in Mandible
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria 1 - complete or partial edentulism in mandible (in the case of partial edentulous, edentulous space and the size of at least 2 teeth posterior mental foramen is located) 2 - bone height in radiogheraphy is at least 13 mm to permit to insert an implant with 11 mmlength.
Exclusion criteria 1 - systemic disease such as diabetes, cardiovascular disorders, or blood problems. 2 - smoking (more than 10 cigarettes per day)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
khorasegan (Isfahan)Islamic Azad University
Street address
khorasegan (Isfahan)Islamic Azad University
City
Isfahan
Postal code
Approval date
2010-06-12, 1389/03/22
Ethics committee reference number
23810201891010
Health conditions studied
1
Description of health condition studied
implant insertion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Implant stability
Timepoint
0,1,2,4,6,8 weeks
Method of measurement
With periotest unit
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, one implant in each patient is dipped with outogenous Platelet-Rich Plasma before insertion. surface of implant was dipped with Platelet-Rich Plasma for 30 seconds.
Category
Treatment - Other
2
Description
In control group, one implant in each patient was inserted without dipping in Platelet-Rich Plasma.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty - Islamic Azad university Khorasgan branch (Isfahan)
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Khorasgan branch
Full name of responsible person
Vahid Esfahanian
Street address
university bulv. - jay street - Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Khorasgan branch
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
Islamic Azad University khorasgan branch (Isfahan)
Full name of responsible person
Narges Fahami
Position
Periodontist
Other areas of specialty/work
Street address
Number 4 - East yas Street- Ghobadi street - Ferdos Bulv. -Tehran
City
Tehran
Postal code
Phone
+98 21 4405 5206
Fax
Email
n.fahami@khuisf.ac.irnargesfahami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Khorasgan branch (Isfahan0
Full name of responsible person
Narges Fahami
Position
Periodontist
Other areas of specialty/work
Street address
Number 4 - East yas Street- Ghobadi street - Ferdos Bulv. -Tehran
City
Tehran
Postal code
Phone
+98 21 4405 5206
Fax
Email
n.fahami@khuisf.ac.irnargesfahami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Narges Fahami
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)