Fifty patients are going to be selected according to the stated inclusion (20-60 years old, partial edentulous patients, at most 2 implants, non-submerged technique) and exclusion (systemic diseases, smoker patients, periodontal involved, need to bone augmentation procedures in surgical area) criteria. Provided the patients accept to participate in the study, they are assigning to test (administering Amoxicillin “500 mg” after implant surgery) and control (administering placebo after implant surgery) groups, randomly. Drugs are prescribed every eight hours for seven days. Samples are taken from the sites adjacent to the implant with a paper-point 30 minutes and one week after implant placement. Samples are then sent to microbiologic department to culture the bacteria growing in the paper-point. The changes in the bacterial colonization are going to be assessed inter-groups and intra-group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706101150N1
Registration date:2008-10-29, 1387/08/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2008-10-29, 1387/08/08
Registrant information
Name
Neda Moslemi
Name of organization / entity
Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 3902
Email address
nmoslemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental faculty - Tehran University of Medical Sciences
Expected recruitment start date
2008-11-22, 1387/09/02
Expected recruitment end date
2012-01-01, 1390/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of administration of Amoxicillin after Implant surgery on Bacterial colonization adjacent to Implant Surgical Site: Microbiologic Study
Public title
The Effect of Amoxicillin on Bacterial colonization adjacent to Implant Surgical Site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- 20-60 years old patients.
2- partial edentulous patients
3- At most, two implants are inserted
4- non-submerged surgical technique
Exclusion criteria:
1- Smoker patients
2- periodontal involved
3- need to perform bone augmentation procedures in surgical area
4- patients who are involved in relevant systemic diseases
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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 Ave., Keshavarz Blv.,Tehran University of Medical Sciences
City
Tehran
Postal code
99694-47166
Approval date
2008-07-01, 1387/04/11
Ethics committee reference number
7060-70-02-87
Health conditions studied
1
Description of health condition studied
Prophylactic antibiotic administration after dental implant surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
microbial colonization
Timepoint
30 minutes after surgery and 1 week after surgery
Method of measurement
Microbiologic culture
Secondary outcomes
1
Description
pain
Timepoint
One week fter surgery
Method of measurement
Visual scale
2
Description
swelling
Timepoint
One week after surgery
Method of measurement
Observation (yes/no)
Intervention groups
1
Description
Intervention group: Amoxicillin administration, 500mg/8h for one week
Category
empty
2
Description
placebo administration in control group
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty
Full name of responsible person
Neda Moslemi
Street address
Ghods Ave., Keshavarz Blv., Dental Faculty,Tehran University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Street address
Ghods Ave., Keshavarz Blv., Dental Faculty,Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
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 Faculty-Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Position
Periodontist / Assistant Professor
Other areas of specialty/work
Street address
Ghods Ave., Keshavarz Blv., Dental Faculty,Tehran University of Medical Sciences
City
Tehran
Postal code
47166-99694
Phone
+98 21 8897 3902
Fax
Email
nmoslemi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Position
Periodontist/Assistant Professor
Other areas of specialty/work
Street address
Ghods Ave., Keshavarz Blv., Dental Faculty,Tehran University of Medical Sciences
City
tehran
Postal code
47166-99694
Phone
+98 21 8897 3902
Fax
Email
nmoslemi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Position
Periodontist/Assistant Professor
Other areas of specialty/work
Street address
Ghods Ave., Keshavarz Blv., Dental Faculty,Tehran University of Medical Sciences
City
tehran
Postal code
47166-99694
Phone
+98 21 8897 3902
Fax
Email
nmoslemi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)