Chronic periodontitis is an inflammatory disease of the tooth supporting tissues which is caused by micro organisms residing in the subgingival bio film . This chronic inflamation will progressively destruct the periodontal ligament. The basic treatment plan is oral hygiene instruction,removal of irritation factors and scaling and root planning(SRP). The effect of SRP in treatment of chronic periodontitis has been previously proved by several studies. The purpose of this study is to evaluate azithromycin as an adjunct to SRP treatment in patients with chronic periodontitis . This study is a randomized, double blinded, placebo controlled study.Inclusion criteria: having at least 20 teeth and at least 18 years of age.
exclusion criteria: pregnancy, allergy to macrolids, SRP in the last 6 months
40 individuals-divided equally into 2 groups.
Intervention: administration of azithromycin only on the first day of treatment until 3 days.
result: improvement in clinical signs of gingiva
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071518493N1
Registration date:2015-03-06, 1393/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-06, 1393/12/15
Registrant information
Name
Leila Gholami
Name of organization / entity
Hamadan University of Medical Sciences, Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 1949
Email address
l.gholami@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-02-23, 1393/12/04
Expected recruitment end date
2015-10-12, 1394/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of systemic administration of azithromycin following non-surgical treatment in patients with moderate chronic periodontitis
Public title
Azithromycin's effect on periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:non smoker patient;18 years old or more;with at least 20 teeth
Exclusion criteria:pregnancy;antibiotic therapy in the last 3 months;use of any antibiotics during the study;allergy to macrolids;use of warfarin or cyclosporins;immune system insufficiency
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Zahedan University of Medical Science
Street address
Zahedan University of Medical Science-Dr.Hesabi square
City
Zahedan
Postal code
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
6731
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic pericoronitis Periodontitis: NOS complex simplex
Primary outcomes
1
Description
Pocket depth
Timepoint
pre treatment,2 weeks after treatment,1 month after treatment,3 month after treatment
Method of measurement
distance between gingiva margin to base of pocket by williams probe
2
Description
Clinical attachment level
Timepoint
pre treatment,2 weeks after treatment,1 month after treatment,3 month after treatment
Method of measurement
distance between cej to base of pocket by williams probe
3
Description
Gingival index
Timepoint
pre treatment,2 weeks after treatment,1 month after treatment,3 month after treatment
Method of measurement
by O'Leary technique
4
Description
Plaque index
Timepoint
pre treatment,2 weeks after treatment,1 month after treatment,3 month after treatment
Method of measurement
by O'Leary technique
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Administrating azithromycin 250 mg for 3 days,2 pills per day,Scaling Root Planing ,Oral hygiene instruction.
Category
Treatment - Drugs
2
Description
Control group:Administrating placebo for 3 days,2 pills per day.Scaling Root Planing,oral hygiene instructions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Gholami
Street address
Periodontology departement, Dentistry School, Mehr st
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Rafigh doost
Street address
Zahedan University of Medical Sciences-Dr.Hesabi square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Soroosh Mokhtari
Position
Dentist
Other areas of specialty/work
Street address
Dentistry School, Mehr st
City
Zahedan
Postal code
Phone
+98 54 3341 4004
Fax
Email
soroosh.mokhtari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Leila Gholami
Position
Periodontologist
Other areas of specialty/work
Street address
Dentistry School-Mehr st
City
Zahedan
Postal code
Phone
+98 54 3341 4004
Fax
Email
l.gholami@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Leila Gholami
Position
Periodontologist
Other areas of specialty/work
Street address
Periodontology department, Dentistry School, Mehr st.
City
Zahedan
Postal code
Phone
+98 54332414004
Fax
Email
l.gholami@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)