Effect of hydroalcholic extract of green tea mouth wash will be evaluated on gingivitis in this study. The study is double blinded clinical trial. The patients will randomly divide into two groups of test and control. Each group will consist of twenty five patients suffering from plaque induced gingivitis who were referred to periodontics department of Hamadan dentistry faculty. Hydroalcholic extract of green tea for test group and chlorhexidine mouth wash will be used for control group. Plaque index, bleeding on probing and gingival index variables will measure on base line, one month and two months after mouthwash usage. All examinations and measurements will be done by one dentist with Williams's periodontal probe. Plaque index will be evaluated by disclosing agent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111223468N3
Registration date:2017-05-03, 1396/02/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-03, 1396/02/13
Registrant information
Name
Nazli Rabienejad
Name of organization / entity
Hamadan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1059
Email address
n.rabinezhad@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2017-05-10, 1396/02/20
Expected recruitment end date
2017-12-10, 1396/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of green tea mouthwash on gingival indices in gingivitis suffered patients
Public title
Evaluation the effect of green tea mouthwash on gingival health
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: diagnosis of plaque induced gingivitis.
Exclusion: systemic disease; pregnancy; smoking; antibiotic consumption during study and six month before; any other mouth wash during study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Commitee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Mardom street
City
Hamedan
Postal code
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.UMSHA.REC.1395.322
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Gingivitis (chronic): NOS desquamative hyperplastic simple marginal ulcerative
Primary outcomes
1
Description
Plaque index
Timepoint
Baseline, one and two months after
Method of measurement
Inspection
2
Description
Bleeding on probing
Timepoint
Baseline, one and two months after
Method of measurement
Periodontal prob
3
Description
Gingival index
Timepoint
Baseline, one and two months after
Method of measurement
Inspection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: green tea mouth wash twice a day for 2 months
Category
Treatment - Other
2
Description
Control group: placebo mouthwash twice a day for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Dental Faculty
Full name of responsible person
Nazli Rabinejad
Street address
Hamedan Dental Faculty, Mardom street
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Hamedan University of Medical Sciences, Mardom street
City
Hamedan
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, Hamedan University of Medical Sciences