Green tea effects on clinical indexes and Salivary Cytokines level of Patients with chronic periodontitis as first phase complement for periodontal treatment
Objectives: Green tea effects on patients with chronic periodontitis as first phase complement for periodontal treatment
Design: Systematic effects of green tea due to its antibacterial and anti-inflammatory especially in inaccessible places for scaling as first phase complement of periodontal treatment (sanitarian education and scaling and root planning)
Setting and conduct: Patients are selected from department of periodontology in Shahed School of Dentistry based on inclusion criteria and getting individuals written consents. Afterwards, clinical criteria are recorded and saliva samples are taken. In the following, in addition to teeth scaling, green tea is given to the intervention group in order to drink according to given instructions and the control group only takes teeth scaling. Moreover, after six week, clinical criteria are recorded once again and saliva samples are taken. The results of the salvia samples are studied using ELISA test. Dividing the patients into two groups will be done by one person and scaling and saliva samples by someone else.
Input conditions: Existence of 2 teeth with 5 millimeters or more teeth pocket depth in each quadrant; existence of bleeding caused by probing (BOP) in pockets with size of 5 millimeters or more; clinical attachments loss which are more than 3 millimeters; research condition acceptance.
Output conditions: Catching systemic disease; pregnancy and breastfeeding sicknesses; periodontal treatment receiving in last 6 months; smoking and drinking alcohol; antibiotic and NSAIDs taking history in last 6 months and green tea drinkers who drink more than one cup in a week and a fixed orthodontic appliance people
Intervention: Chronic Periodontal patients divide into two groups. In the first group (15 people) the saliva is collected but there will not be any interventions. In this case the group is controlling. In the second group (15 people) patients drink green tea before scaling for 6 weeks. In both groups saliva is collected after 6 weeks
Main outcome measures: The amount of 1 and 6 salivary interleukin and clinical criterion (pocket depth, bleeding and plaque indexes).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015113025296N1
Registration date:2016-05-21, 1395/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Gita Rezvani
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
g.rezvani@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
The grant of project executive from vice chancellor for assistance of Shahed University
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Green tea effects on clinical indexes and Salivary Cytokines level of Patients with chronic periodontitis as first phase complement for periodontal treatment
Public title
Green tea effects on clinical indexes and Salivary Cytokines level of Patients with chronic periodontitis as first phase complement for periodontal treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Existence of 2 teeth with 5 millimeters or more teeth pocket depth in each quadrant; existence of bleeding caused by probing (BOP) in pockets with size of 5 millimeters or more; clinical attachments loss which are more than 3 millimeters; research condition acceptance.
Exclusion criteria: Catching systemic disease; pregnancy and breastfeeding sicknesses; periodontal treatment receiving in last 6 months; smoking and drinking alcohol; antibiotic and NSAIDs taking history in last 6 months and green tea drinkers who drink more than one cup in a week; a fixed orthodontic appliance people.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of Shahed University
Street address
Shahed university, front of the Holy Shrine of Imam Khomeini, Persian Gulf Highway (Tehran-Qom), Tehran, Iran
City
Tehran
Postal code
Approval date
2014-12-29, 1393/10/08
Ethics committee reference number
shahed.rec.1393/29
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 bleeding index (Ainamo & Bay)
Timepoint
6 week
Method of measurement
William`s periodontal probe
2
Description
Plaque index (O'leary index)
Timepoint
6 week
Method of measurement
William`s periodontal probe
Secondary outcomes
1
Description
IL1 beta consentration
Timepoint
6 week
Method of measurement
ELISA
2
Description
IL6 consentration
Timepoint
6 week
Method of measurement
ELISA
Intervention groups
1
Description
1.75 gram green tea in 500 milliliter boiling water as an anti-inflammatory and anti-bacterial agent twice in day for 6 week after first phase of periodontal treatment was prescribed for study group and only first phase of periodontal treatment for control group
Category
Treatment - Other
2
Description
Control group: Only first phase of periodontal treatment will be done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology department of Shahed university`s dental College
Full name of responsible person
Dr Ferial Taleghani
Street address
Faculty of Dentistry of Shahed University, Italy street, Vesal and Qods interval, Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed university
Full name of responsible person
Dr Zahra Kiasalari
Street address
Shahed university, front of the Holy Shrine of Imam Khomeini, Persian Gulf Highway (Tehran-Qom), Thehran, Iran
City
Tehran
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, Shahed university
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
Dental college of Shahed university
Full name of responsible person
Dr Gita Rezvani, Dr Ferial Taleghani
Position
Assistant professor of oral pathology, Assistant professor of periodontology
Other areas of specialty/work
Street address
Faculty of Dentistry of Shahed University, Italy street, Vesal and Qods interval, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 8895 9210
Fax
Email
g.rezvani@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental college of Shahed university
Full name of responsible person
Dr Gita Rezvani, Dr Ferial Taleghani
Position
Assistant professor of oral pathology ,Assistant professor of periodontology
Other areas of specialty/work
Street address
Faculty of Dentistry of Shahed University, Italy street, Vesal and Qods interval, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 8895 9210
Fax
Email
g.rezvani@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental college of Shahed university
Full name of responsible person
Maryam Valizadeh, Mahnaz Birjandi
Position
Dentistry student, Dentistry student
Other areas of specialty/work
Street address
Faculty of Dentistry of Shahed University, Italy street, Vesal and Qods interval, Keshavarz Boulevard
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)