The aim of this study was to evaluate the effectiveness of green tea chowing gums on the gingivitis. In a randomized clinical trial, 45 patients with gingivitis were selected. 22patient were choose to use placebo chewing gums and 23 patient had to use green tea chewing gums. In this study scaling hasn`t been done on the patient because it effects on the result of measurement. At first the condition of periodontal and oral hygiene of the patient has been studied. At first meeting, the saliva of patient was supplied in the way of [an stimulated ] for testing of inflammation factor IL1a. Also the index of approximate plaque(API) and sulcus bleeding(SBI) were measured. At the first meeting 42 chewing gums were given to every patients. They had to chew 2 of them every day for 20 minutes.7 days after the first meeting, only the indexes were measured. 21 day after the first meeting all the measurements were repeated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403155570N6
Registration date:2014-04-12, 1393/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Parichehr Behfarnia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1666 1707
Email address
behfarnia@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-09-09, 1392/06/18
Expected recruitment end date
2014-01-25, 1392/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical and patological effect of green tea on the periodontal gingivitis
Public title
The effect of green tea chowing gums on the inflamation of the gingiva
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion ctiteria: gingivitis suffering; good patient coapration;having mor than 20 teeth. Exclusion criteria: having sistemic diseas; using the drugs that effects on gums; using tabacco products; pregnancy.
Age
From 28 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Isfahan University Of Medical Sciences
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
8174673461
Approval date
2013-09-18, 1392/06/27
Ethics committee reference number
393031
Health conditions studied
1
Description of health condition studied
gingivitis
ICD-10 code
KO5
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
aproximal plaque index
Timepoint
Base line(before treatment), 7 day afte Base line,21 day
Method of measurement
Clinical Evaluation( by periodontal prob)
Secondary outcomes
1
Description
IL1a
Timepoint
Base line(before treatment), 21 day after Base line
Method of measurement
ELISA test
2
Description
Sulcus bleeding index
Timepoint
Base line(before treatment), 7 day after Base line,21 day after Base line
Method of measurement
Clinical Evaluation(Probing by periodontal prob)
Intervention groups
1
Description
Intervention Group: Oral hygiene instruction,use of green tea gums for21 days after beginning study,2 on day
Category
Treatment - Drugs
2
Description
Control group: Oral hygeine instruction,use of placebo gums for21 days after beginning study,2 on day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics Department, Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Grant name
تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1666 1707
Fax
+98 31 1668 7080
Email
behfarnia@den.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1666 1707
Fax
+98 31 1668 7080
Email
behfarnia@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1666 1707
Fax
+98 31 1668 7080
Email
behfarnia@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)