The aim of this study is to compare Amoxicillin–Metronidazole effects with Farmentin (a new compound of Co-Amoxiclave) in the treatment of moderate chronic periodontitis. In this single blind trial, 60 patients (30 females and 30 males) with chronic moderate periodontitis were evaluated. SRP and OHI were done for all patients similarly. Patients were divided into three groups to receive Farmentin or Amoxicillin plus Metronidazole for one week or nothing in the control group. Periodontical Disease Index (PDI), Gingival Index (GI), Modified Papillary Bleeding Index (MPBI), plaque index (PLI) and Probing packet Depth (PPD) were measured at the baseline, a week after scaling and before taking medicine, 1, 3, and 6 weeks after taking medicine and 2, 3 months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902073813N1
Registration date:2006-02-20, 1384/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2006-02-20, 1384/12/01
Registrant information
Name
Niloofar Jenabian
Name of organization / entity
Dental Faculty of University of Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
n.jenabian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental Faculty of Babol University of Medical Sciences
Expected recruitment start date
2006-02-20, 1384/12/01
Expected recruitment end date
2008-11-03, 1387/08/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Farmentin and combined Amoxicilin-Metronidazole in the treatment of Moderate Chronic Periodontits
Public title
Farmentin comparing with Amoxicilin-Metronidazole in the treatment of Moderate Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 30-50, at least one pocket with PPD>4mm in each quadrant
Excluding criteria: Systemic Disease Involvement, History of Antibiotic therapy during last 6 month
Age
From 30 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Babol Medical Science
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Postal code
4717641367
Approval date
empty
Ethics committee reference number
694
Health conditions studied
1
Description of health condition studied
Moderate Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic Periodontitis
Primary outcomes
1
Description
Periodontal Disease Index
Timepoint
Baseline, one, three, and six weeks, two and three months after the intervention
Method of measurement
Periodontal Disease Index Russel
Secondary outcomes
1
Description
إBleeding Index
Timepoint
Baseline, one, three, and six weeks, two and three months after the intervention
Method of measurement
Bleeding Index Barnett
2
Description
Gingival Index
Timepoint
Baseline, one, three, and six weeks, two and three months after the intervention
Method of measurement
Gingival Index Loe &Silness
3
Description
plaque index
Timepoint
Baseline, one, three, and six weeks, two and three months after the intervention
Method of measurement
plaque index Silness & Loe
4
Description
probing pocket depth
Timepoint
Baseline, one, three, and six weeks, two and three months after the intervention
Method of measurement
Periodontal Probe
Intervention groups
1
Description
Farmentin suspention 457mg, BD, for 7 days
Category
Treatment - Drugs
2
Description
Amoxicilin, capsule 500mg plus Metronidazole tablet 250mg, three times a day, for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty
Full name of responsible person
Niloofar Jenabian
Street address
Felestin st., Velayat sq.
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Faculty
Full name of responsible person
Niloofar Jenabian
Street address
Felestin st., Velayat sq.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Faculty
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Position
Periodontology Board
Other areas of specialty/work
Street address
Felestin st., Velayat sq.
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
+98 11 1229 1093
Email
njenabian@hotmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)