Protocol summary

Summary
the periodontal disease is a common cause of dentoalveolar problems and curcumin has an antioxidant and antiflammatory properties and it can protect from oxidative stress and relief the pain.so this study tries to evaluate the effect of curcumin in clinical parameter after scaling and root planning in the patient with moderate chronic periodontitis.the samples are selected from the patients who refer to dental faculty of babol. The clinical parametersgingival index (GI) Loe and Silness , Bleeding index (BI)Mombelli, the probe depth and the clinical level would be recorded in the beginning of the study and the 8 weeks and 4 months later. All the patients would be under scaling and root planning. The group of patients after the scaling and root planning would take BCM-95 Curcumin 500mg twice daily as oral capsules for 8 months. The ones of the control group would take the placebo. For blinding we will use same color capsule in same and coded boxes. after finishing the plan and statistical analysis, the codes are declared. Using the SPSS statistical software and the T-Test statistical tests, the difference between the data would be analyzed.the control group take placebo. patients,analizer,and practitioner don't know which group receives placepo.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014070918413N2
Registration date: 2014-08-14, 1393/05/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-08-14, 1393/05/23
Registrant information
Name
Farhad Dabbagh Sattari
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 1555
Email address
fdabbaghsattari@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
babol university of medical science, the drug producer company
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Biocurcumax TM Curcumin (BCM-95) In Patients With Moderate Chronic Periodontitis
Public title
The Effect Of Biocurcumax TM Curcumin (BCM-95) In Patients With Moderate Chronic Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: In the present clinical trial study, 30 patients who are systemically healthy, but suffering from moderate chronic Periodontitis were selected. They had at least one periodontal pocket of a probe depth of 4-6 millimeters in each quadrant and bleeding during the probe. The patients who had a background of tooth scaling and root planning within the past 12 months; Exclusion criteria: those with high risk medical conditions, pregnant or breast feeding mothers, those who were cured with antibiotics or anti-inflammatory, antioxidants, or anti TNF-α within the past 6 months, as well as the presently smokers and those who have quit smoking within 1 year of the study, are not included in the research.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Science, Vice Chancellor for Research and Technology
Street address
Babol, Ganj Afrouz Street, Babol University of Medical Science, Vice Chancellor for Research and Technology
City
babol
Postal code
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
4232

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
gingival index
Timepoint
0, 8 week later,4 month later
Method of measurement
the method of silness&loe,using periodontal probe

2

Description
clinical attachment level
Timepoint
0, 8 weeks later,4 month later
Method of measurement
with probe

3

Description
gingival sulcus bleeding index
Timepoint
0 ,8weeks later,4 month later
Method of measurement
after using probe,wait for 15 seconds

4

Description
probinf pocket depth
Timepoint
0, 8weeks later ,4 month later
Method of measurement
probe periodontal

Secondary outcomes

empty

Intervention groups

1

Description
in cases for 4 weeks, two capsules(500mg) within meal will be given.
Category
Treatment - Drugs

2

Description
in the control group for 4 weeks 2 Placebo capsules with meals will be given.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol University of Medical Sience, Faculty of Dentistry, Department of Periodontics
Full name of responsible person
hedieh ehsani
Street address
Babol, Ganj Afruz Street, Babol University of Medical Sience
City
babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sience, Vice Chancellor for Research and Technology
Full name of responsible person
Hedieh Ehsani
Street address
Babol University of Medical Sience, Ganj Afruz Street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sience, Vice Chancellor for Research and Technology
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
Babol University of Medical Sience
Full name of responsible person
Hedieh Ehsani
Position
student
Other areas of specialty/work
Street address
Babol University of Medical Sience, Ganjafruz street, Babol
City
Babol
Postal code
Phone
+98 11 3222 4032
Fax
Email
hediehehsani9@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sience
Full name of responsible person
Farhad DabbaghSattari
Position
Periodontologist
Other areas of specialty/work
Street address
Babol University of Medical Sience, Ganjafruz street, Babol
City
Babol
Postal code
Phone
+98 11 3222 4032
Fax
Email
hediehehsani9@gmail.com fdabbaghsattari@yahoo.com
Web page address
www.mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Hedieh Ehsani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
hediehehsani9@gmail.com
Web page address

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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