Survey of systemic prescription of Azithromycin using Salivary Occult Blood Test (SOBT) and periodontal parameters in non-surgical treatment of patients with moderate to severe Chronic Periodontitis.
The aim of this study is to determine the effects of periodontal treatment of Azithromycin in patients with chronic periodontitis using salivary occult blood test and periodontal index. The main criterion for inclusion is existence of moderate to severe chronic periodontitis and the main Exclusion criteria are: antibiotic therapy during the last 3 months, periodontal treatment during the last 3 months, systemic disease affecting periodontal condition. The study population are 42 patients with chronic periodontitis, which refer to the Hamedan Dentistry Faculty. They will randomly divide into two groups and after mechanical treatment and scaling, azithromycin is given to the intervention group And after a month, the treatment effects of azithromycin will compared to the control group using periodontal index and salivary occult blood test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052510304N2
Registration date:2015-06-10, 1394/03/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-10, 1394/03/20
Registrant information
Name
Davood Mansoori
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1074
Email address
sr.arabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2015-06-07, 1394/03/17
Expected recruitment end date
2015-07-01, 1394/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of systemic prescription of Azithromycin using Salivary Occult Blood Test (SOBT) and periodontal parameters in non-surgical treatment of patients with moderate to severe Chronic Periodontitis.
Public title
Survey of prescription of Azithromycin in treatment of patients with Chronic Periodontitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years old; have at least 20 teeth; existence of chronic periodontitis.
Exclusion criteria: antibiotics therapy during the last 3 months; a history of allergy to macrolides; smokers (more than 5 cigarettes a day); periodontal treatment during the last 3 months; systemic diseases affecting the periodontal condition such as diabetes; blood disorders and diseases of the immune system (systemic disease according to patient and medical history evaluated); patients treated with drugs Anitacid and Cyclosporine; patients with anemia (anemia according to patient and medical history estimated); patients with thrombocytopenia and liver defects; patients with leukemia; the use of aspirin and other anticoagulants; use Corticosteroids (up to one year).
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Hamedan University Of Medical Sciences
Street address
Hamedan, Mahdiyeh Street , Fahmideh Street, In Front Of Mardom Park, Hamedan University Of Medical Sciences, Dentistry Faculty
City
Hamedan
Postal code
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
UMSHA.REC.1394,36
Health conditions studied
1
Description of health condition studied
Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Probing Depth
Timepoint
Before Intervention And 1 Mounth After Intervention And 2 Mounth After Intervention
Method of measurement
Milimeter
2
Description
Bleeding on Probing
Timepoint
Before Intervention And 1 Mounth After Intervention And 2 Mounth After Intervention
Method of measurement
Present ( 0 - 100 )
3
Description
Gingival Recession
Timepoint
Before Intervention And 1 Mounth After Intervention And 2 Mounth After Intervention
Method of measurement
Milimeter
4
Description
gingival Index
Timepoint
Before Intervention And 1 Mounth After Intervention And 2 Mounth After Intervention
Method of measurement
0, 1 , 2, 3
5
Description
Clinical Aattachment Level
Timepoint
Before Intervention And 1 Mounth After Intervention And 2 Mounth After Intervention
Method of measurement
Milimeter
6
Description
Salivary Occult Blood
Timepoint
Before Intervention And 1 Mounth After Intervention And 2 Mounth After Intervention
Method of measurement
0, 1
7
Description
Groups
Timepoint
Before Intervention And 1 Mounth After Intervention And 2 Mounth After Intervention