the goal of this study is determine Azithromycin concentration in Gingival Crevicular Fluid (GCF). With the use of a single dose of Azithromycin by a healthy individual deemed to be safe and may not cause health problems. In many case studies and treatment protocols, the use of a single dose by a healthy individual is common. Therefore, we select a group of 30 individuals who were healthy. The individuals consume a single dose of 250 mg; the GCF concentration of the drug is determine in 0, 6, 12 , 36 ,84 and 156 hour . For sampling we use paper cone #30 and gently place samples by applying the intrasulcular method to avoid any mechanical damages to interproximal areas of molar and canine. The samples placed in test tubs contain 0.5 ml NormalSalin and test tube tightly seal, and refrigerate at 4 degree Celsius to prevent deactivation with the enzyme. For determine concentration of Azithromycin with the use of the MTBE solution along with calcium chloride solution is performed . Ultimately, 20 micro liters of the extracted Azithromycin were injected to a device and the data Analyzed.
General information
Acronym
Concentration of Azithromycin in GCF
IRCT registration information
IRCT registration number:IRCT201412033451N2
Registration date:2014-12-23, 1393/10/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-23, 1393/10/02
Registrant information
Name
Mahmood Khosravi samani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
m.khosravi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2014-12-26, 1393/10/05
Expected recruitment end date
2015-02-24, 1393/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining concentration of Azitromycin in GCF after single dose administration in healthy subjects (by HPLC method)
Public title
Determining concentration of Azithromycin in GCF after single dose adminstration
Purpose
Treatment
Inclusion/Exclusion criteria
The eligible and healthy volunteers will be enrolled in this case study only after receiving adequate information regarding purpose of the subject research and providing their consent for participation. Inclusion criteria: are having a gingival index less than 1.5 ; have adequate oral and general health conditions
The exclusion criteria : are taking any oral medication in the last two weeks ; having an allergic reaction to Azithromycin ; gingivitis ; periodontitis ; showing any signs of gingival recession.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
University of Medical Sciences-ganj afrooz avenu
City
babol
Postal code
41367
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
4232
Health conditions studied
1
Description of health condition studied
Determine Concentration of Azithromycin in gingival crevicular fluid
ICD-10 code
Z01.2
ICD-10 code description
Dental examination
2
Description of health condition studied
Concentration of Azithromycin in gingival crevicular fluid
ICD-10 code
Z01
ICD-10 code description
Other special examinations and investigations of persons without complaint or reported diagnosis
Primary outcomes
1
Description
Concentration of Azithromycin in GCF
Timepoint
Ine the 0 . 6 . 12 36 . 84 . 156 hours azithromycin concentrations in GCF checked.
Method of measurement
We used HPLC method for measuring Concentration of Azithromycin in GCF
Secondary outcomes
empty
Intervention groups
1
Description
A group of 30 individuals were selected and a single dose of 250 mg Azithromycin were prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology , School of Dentistry , Babol University of Medical Sciences
Full name of responsible person
Dr Mahmood Khosravi Samani
Street address
Babol University of medical sciences , Ganj afrooz street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Material Center , School of Dentistry , Babol University of Medical Sciences
Full name of responsible person
Dr Homaion Alaghemand
Street address
Babol University of Medical Sciences , Ganjafrooz street
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Material Center , School of Dentistry , Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr Mahmood Khosravi Samani
Position
Periodontologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences , Ganj afrooz street
City
Babol
Postal code
47176
Phone
+98 11 3219 9592
Fax
Email
m.khosravi@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Aliakbar Moghadamnia
Position
PhD in Pharmacology and Toxicology
Other areas of specialty/work
Street address
Department of Pharmacology , Faculty of Medicine , Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
a.moghadamnia@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khashayar Dehshiri
Position
Dental student
Other areas of specialty/work
Street address
Babol University of Medical Sciences , Ganjafrooz street
City
Babol
Postal code
41367
Phone
Fax
Email
drdehshiry@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)