Protocol summary

Summary
The aim of this study is evaluation the effect of cocoa on total antioxidant power and lipid oxidation in saliva on patients whit chronic moderate periodontitis.in this clinical trial 40 patients who referring on the department of periodontology and have chronic moderate periodontitis will be participate. Inclusion criteria:The patients without history of systemic disease ; The patients without digestive problem;The patients be able to cooperate and have same plaque index. Exclusion criteria: smoker patients; menopause women;the patients who intake nutritional and vitamin supplements; the patients who cocoa and it's products are in they daily nutritional regiment; the patients whit any periodontal treatment during past 6 month; the patients whit antibiotic therapy during 1 month; the patients had taken anti inflammatory drugs during past 1 month. sample size is 40 patients that divided to two groups whit 20 members. The intervention group intake daily 30 gram Idin78% dark chocolate in three dosage for four weeks. The control group intake daily 23.4 gram Idin white chocolate in three dosage for four weeks. primary outcome: Ferric reducing antioxidant power - FRAP ; Thiobarbituric acid reactive substances- TBARS .secondary outcomes: Gingival Index; Modified Papillary Bleeding Index; Probing Pocket Depth; Probing Pocket Depth; Attachment loss

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201309303813N3
Registration date: 2014-05-29, 1393/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-29, 1393/03/08
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
Vice chancellor for research and thechnology
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of cocoa on total antioxidant capacity and lipid oxidation in saliva on moderate chronic periodontitis.
Public title
The evaluation of the effect of cocoa on periodontal disaese
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:The patients without history of systemic disease ; The patients without sensitivity to coca and it's products;The patients age between 30 to 50 ; The patients have chronic moderate periodontitis ;The patients be able to cooperate and have same plaque index; The patients without digestive problem Exclusion criteria: smoker patients; menopause women;the patients who intake nutritional and vitamin supplements; the patients who cocoa and it's products are in they daily nutritional regiment; the patients whit any periodontal treatment during past 6 month; the patients whit antibiotic therapy during 1 month; the patients had taken anti inflammatory drugs during past 1 month.
Age
From 30 years old to 50 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)
Single blinded
Blinding description
Placebo
Not 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
4717641367
Approval date
2013-11-09, 1392/08/18
Ethics committee reference number
3326

Health conditions studied

1

Description of health condition studied
Moderate Chronic Periodontitis
ICD-10 code
k05.3
ICD-10 code description
Chronic Periodontitis

Primary outcomes

1

Description
Total Antioxidant Power
Timepoint
At base line and One month after intervention
Method of measurement
Ferric Reducing Antioxidant power test-FRAP

2

Description
Saliva lipid preoxidation
Timepoint
At base line and One month after intervention
Method of measurement
Thiobarbituric Acid Reactive Substances test-TBARS

Secondary outcomes

1

Description
Gingival Index
Timepoint
this index will be recorded at base line and 2 , 4 ,6 and 8 weeks later.
Method of measurement
loe and silness method

2

Description
Modified papillary bleeding index
Timepoint
this index will be recorded at base line and 2 , 4 ,6 and 8 weeks later.
Method of measurement
Bernet method

3

Description
Probind pocket depth
Timepoint
this index will be recorded at base line and 2 , 4 ,6 and 8 weeks later.
Method of measurement
whit periodontal probe

4

Description
Attachment loss
Timepoint
this index will be recorded at base line and 2 , 4 ,6 and 8 weeks later.
Method of measurement
whit periodontal probe

Intervention groups

1

Description
The intervention group intake daily 30 gram Idin78% dark chocolate in three dosage for four weeks.
Category
Other

2

Description
The control group intake daily 23.4 gram Idin white chocolate in three dosage for four weeks.
Category
Other

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
Niloofar Jenabian
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
Niloofar Jenabian
Street address
Babol, Ganj Afruz Street, Babol University of Medical Sience
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
Niloofar Jenabian
Position
Assistant Professor, Babol University Of Medical Siences, faculty Of Dentistry, Department of Period
Other areas of specialty/work
Street address
Babol, Ganj Afruz Street, Babol University of Medical Sience
City
Babol
Postal code
4717641367
Phone
+98 11 1222 4032
Fax
+98 11 1222 4032
Email
njenabian@hotmail.com njenabian@yahoo.com
Web page address
www.mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sience
Full name of responsible person
Niloofar Jenabian
Position
Periodontologist
Other areas of specialty/work
Street address
Babol, Ganj Afruz street, Babol University of Medical Sience
City
Babol
Postal code
4717641367
Phone
+98 11 1222 4032
Fax
+98 11 1222 4032
Email
njenabian@hotmail.com njenabian@yahoo.com
Web page address
www.mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sience
Full name of responsible person
Niloofar Jenabian
Position
Assistant Professor, Babol University Of Medical Sience, Faculty of Dentistry , Departman of Periodo
Other areas of specialty/work
Street address
Babol, Ganj Afruz street, Babol University of Medical Sience
City
Babol
Postal code
4717641367
Phone
+98 11 1222 4032
Fax
+98 11 1222 4032
Email
njenabian@hotmail.com njennabian@yahoo.com
Web page address
www.mubabol.ac.ir

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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