Protocol summary

Summary
Introduction: In most cases of periodontal therapy, antibiotics are suggested as adjuvant. It is necessary to evaluate the effect of systemic administration of antibiotics in treatment of periodontal diseases and introduce a cost-effective method for managing of periodontal infections in population which do not have access to periodontal therapy. Aim: comparison the effect of antibiotics alone, scaling and root planing (SRP) alone or SRP combined with antibiotics as gold standard approach in Improvement of PPD of patients with chronic periodontitis. Material and Method: This was an experimental study. It was conducted on 44 patients with chronic peridontitis. They were randomly assigned to three groups as follows: 1- SRP Group receiving scaling and root planing alone. 2- AB Group that received antibiotic. 3- Combination Group that received SRP and antibiotic. Clinical measurements including probing depth (PPD) and gingival bleeding index (GBI) and plaque index (PI) were taken – at base line and 3 months after the treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105123720N2
Registration date: 2012-01-18, 1390/10/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-18, 1390/10/28
Registrant information
Name
Roya Shariatmadarahmadi
Name of organization / entity
Department of periodontology, Dental branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
r_shariatmadari@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2009-07-06, 1388/04/15
Expected recruitment end date
2010-04-09, 1389/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of systemic antibiotic alone with scaling and root planing (SRP) in treatment of generalized chronic periodntitis
Public title
Comparison of systemic antibiotic alone with scaling and root planing (SRP) in treatment of generalized chronic periodntitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: more than30years old; at least 12 natural healthy tooth with at least 1 molar in each quadrant; at least 6 pocket with ppd. Exclusion criteria: any systemic disease.
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic azad university, Dental branch
Street address
No 4, Neyestan 10th, Pasdaran
City
Tehran
Postal code
Approval date
2010-05-31, 1389/03/10
Ethics committee reference number
17057

Health conditions studied

1

Description of health condition studied
chronic periodontitis
ICD-10 code
KO5.3
ICD-10 code description
chronic periodontitis

Primary outcomes

1

Description
probing pocket depth
Timepoint
before treatment, 3 month after treatment
Method of measurement
by periodontal probe (mm)

Secondary outcomes

1

Description
gingival bleeding index
Timepoint
before treatment, 3 months after treatment
Method of measurement
visual (percent)

2

Description
plaque index
Timepoint
before treatment, 3 months after treatment
Method of measurement
the Quigly-Hien Plaque index

Intervention groups

1

Description
First or SRP Group: scaling and root planing alone.
Category
Treatment - Other

2

Description
Second or AB Group: antibiotic alone. I. cap.Amoxicillin 500mg, oral, 3times a day, 10days; II. Tab. Metronidazole 250mg, oral, 3 times a day, 10days.
Category
Treatment - Drugs

3

Description
Third or Combination Group: Scaling & root planing and antibiotic. I. cap. Amoxicillin 500mg, oral, 3 times a day, 10days. II. Tab. Metronidazole 250mg, oral, 3 times a day, 10days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic azad university, Dental branch
Full name of responsible person
Dr.Roya Shariatmadar Ahmadi
Street address
N0 4, Neyestan 10th, Pasdaran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dr.Samira Hajisadeghi
Full name of responsible person
Dr.Samira Hajisadeghi
Street address
N0 4, Neyestan 10th, Pasdaran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr.Samira Hajisadeghi
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
Islamic Azad university, Dental branch
Full name of responsible person
Dr.Samira Hajisadeghi
Position
post graduate studant of oral & maxillofacial medicine
Other areas of specialty/work
Street address
N0 4, Neyestan 10th, Pasdaran
City
Tehran
Postal code
Phone
+98 21225445703
Fax
Email
dr.s.hajisadeghi@gmail.com , s_waterlily2004@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental branch of Islamic Azad university
Full name of responsible person
Dr. Roya Shariatmadar Ahmadi
Position
periodontist, assistant prof. of department of periodontics of Azad university
Other areas of specialty/work
Street address
No 4, Neyestan 10th, Pasdaran
City
Tehran
Postal code
Phone
+98 21225645703
Fax
Email
dr.r.shariatmadari@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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