The aim of this study is comparison the effect of scaling and root planning (as the standard non-surgical treatment) on salivary and serum Visfatin. Study design is interventional, non randomized and no using of placebo. In this clinical trial study, 18 patients with moderate to severe chronic periodontitis and BMI 18-24.9 kg /m2, who had referred to the Periodontics Department of Tabriz Dental Faculty, will be included. Gingival index, probing pocket depth and clinical attachment level will be measured for diagnosis of periodontitis. 5 milliliters of blood and 3 milliliters of saliva will be collected and immediately transferred to the laboratory. Salivary and serum Visfatin will be measured at baseline and one month after scaling and root planning by Visfatin Eliza kit. Primary outcome is the change of serum and salivariy Visfatin before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012080510501N1
Registration date:2012-08-25, 1391/06/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-08-25, 1391/06/04
Registrant information
Name
Nader Abolfazli
Name of organization / entity
Departyment of periodontics, Tabriz faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
abolfazli@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research of Tabriz university of medical sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of non-surgical periodontal treatment on salivary and serum visfatin in generalized moderate to severe chronic periodontitis
Public title
The effect of non-surgical periodontal treatment on salivary and serum visfatin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: individuals whit BMI 18-24.9 kg/m2; natural teeth ≥20; GI>1; moderate to severe chronic periodontitis in which at least 30% sites have CAL≥3mm and PPD≥5mm and radiographic signs of bone loss are present. Exclusion criteria: individuals with systemic diseases that can alter the course of periodontal disease; pregnancy or lactation; hypertension; aggressive periodontitis; history of using anti hyperlipidemia medication or antibiotic in the preceding 6 months; ongoing usage of NSAIDs; a smoking habit; or those who had received scaling and root planning in the preceding 6 months.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Daneshgah st.
City
Tabriz
Postal code
Approval date
2012-07-09, 1391/04/19
Ethics committee reference number
3953/4/5
Health conditions studied
1
Description of health condition studied
generalized modorate to severe chronic periodontitis
ICD-10 code
k05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
serum visfatin
Timepoint
before intervention, one month after intervention
Method of measurement
Eliza kit
2
Description
salivary visfatin
Timepoint
before intervention, one month after intervention
Method of measurement
Eliza kit
Secondary outcomes
1
Description
gingival index
Timepoint
before intervention, one month after intervention
Method of measurement
gingival index score
2
Description
clinical attachment level
Timepoint
before intervention, one month after intervention
Method of measurement
prob
3
Description
clinical pocket depth
Timepoint
before intervention, one month after intervention
Method of measurement
prob
Intervention groups
1
Description
Scaling and root planning by ultrasonic and hand instruments
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
department of periodontics, Tabriz faculty of dentistry
Full name of responsible person
Dr. Nader ASbolfazli
Street address
Department of Periodontics, faculty of dentistry, Daneshgah street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for research of Tabriz university of medical sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Faculty of dentistry, Daneshgah street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellor for research of Tabriz 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
Tabriz faculty of dentistry
Full name of responsible person
Dr. Nader Abolfazli
Position
Associate Professor of periodontics
Other areas of specialty/work
Street address
faculty of dentistry, department of periodontics, Daneshgah street
City
Tabriz
Postal code
5166614713
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Abolfazli@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences, faculty of dentistry
Full name of responsible person
Dr. Nader Abolfazli
Position
Associate Professor of periodontics
Other areas of specialty/work
Street address
Department of periodontics, Faculty of dentistry, Daneshgah street
City
Tabriz
Postal code
5166614713
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Abolfazli@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences, faculty of dentistry
Full name of responsible person
Sahar Jabali
Position
Post graduate student of periodontics, Professional doctorate
Other areas of specialty/work
Street address
Department of periodontics, faculty of dentistry, Daneshgah street
City
Tabriz
Postal code
5166614713
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
saharj92@gmail.com
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)