Protocol summary

Summary
This is a randomized, double-blind, controlled, clinical trial which aims to evaluate the effects of green tea mouthwash containing one percent tannin on plaque accumulation, gingivitis, and tooth staining. One tenth percent chlorhexidine mouthwash is used as positive control.40 subjects recruiting from the students of dentistry faculty of Guilan University of Medical Sciences , all of which are systemically healthy , are not under any medication, do not have dental prostheses, and do not wear orthodontic appliances, participate in this study. Upon entry, they sign an informed consent and randomly assign in case and control groups. Plaque and gingival indices as well as gingival bleeding index are recorded at baseline. Scaling and polishing are performed and plaque index score is decreased to zero. During the study period, participants follow their routine oral hygiene methods and are advised not to use any mouthwash other than their respected one. All the participants are provided with a calibrated cup and mouthwashes in dark, coded bottles and are instructed to use 15 ml of the mouthwash twice daily for 1 minute during the 4 weeks of trial. All the indices plus tooth staining index are recorded after 1 and 4 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302241081N7
Registration date: 2014-09-14, 1393/06/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-14, 1393/06/23
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology, Guilan University of Medical Sciences
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2013-06-10, 1392/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Green Tea Mouthwash Containing 1 % Tannin on Plaque, Gingivitis and tooth staining
Public title
Effect of green tea Mouthwash on Gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adult subjects with age range of 18-25; Systemically healthy; having mild to moderate gingivitis; having gingival index score of 1 at baseline; having at least 20 standing teeth. Exclusion criteria: Having periodontal pocket ; having clinical attachment loss; being under medication; smoking; mouth breathing,; severe tooth crowding; wearing orthodontic appliances ; having any type of dental prostheses.
Age
From 18 years old to 25 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Opposite Sepah Bank, Vest Beheshti Blv.
City
Rasht
Postal code
4193893345
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
3910396406

Health conditions studied

1

Description of health condition studied
Chronic Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
stain severity index
Timepoint
Baseline, 1, and 4 weeks
Method of measurement
Stain index, Lobene, 1968

2

Description
Gingival bleeding index
Timepoint
Baseline, 1, and 4 weeks
Method of measurement
Gingival Bleeding Index (Ainamo & Bay, 1975)

3

Description
Gingival Index
Timepoint
Baseline, 1, and 4 weeks
Method of measurement
Gingival Index (Loe & Silness, 1963)

4

Description
Stain extent index
Timepoint
Baseline, 1, and 4 weeks
Method of measurement
Stain index, Lobene, 1968

5

Description
Plaque Index
Timepoint
Baseline, 1, and 4 weeks
Method of measurement
Plaque Index: Turskey Modification of Quigley Hein

Secondary outcomes

1

Description
Decrease in plaque index
Timepoint
1 and 4 weeks after intervention
Method of measurement
Plaque Index: TMQH

2

Description
Decrease in gingival bleeding index
Timepoint
1 and 4 weeks after intervention
Method of measurement
Gingival Bleeding Index: Ainamo & Bay

3

Description
Decrease in Gingival Index
Timepoint
1 and 4 weeks after intervention
Method of measurement
Gingival Index: Loe & Silness

Intervention groups

1

Description
The intervention group use green tea mouthwash containing 1% Tannin
Category
Treatment - Drugs

2

Description
The control group use 0.1% chlorhexidine mouthwash
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry Guilan University of Medical Sciences
Full name of responsible person
Dr. Golpar Radafshar
Street address
Facultly of Dentistry, further than Khazar restaurant, Pro. Samiei Blv. Gaz Square
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Susan Komaie
Street address
Opposite Sepah band, West Shahid Beheshti Blv. Gaz Square
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Nastaran Mirfarhadi
Position
MS Nursing education
Other areas of specialty/work
Street address
Guilan University of Medical Sciences Complex Buildings, Faculty of Dentistry, Saravan Free way, Lakan Road
City
Rasht
Postal code
4194173774
Phone
+98 13 1326 3616
Fax
+98 13 1326 3616
Email
mirfarhadi@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Dentistry, Guilan University of Medical Sciences
Full name of responsible person
Dr. Golpar Radafshar
Position
Associate Professor of Periodontology/ Head of Dental and Maxilloracial developmental disease resear
Other areas of specialty/work
Street address
Gillan University of Medical Sciences Complex Buildings, Faculty of Dentistry,Saravan Free way, Lakan Road
City
Rasht
Postal code
4194173774
Phone
+98 13 1326 3616
Fax
+98 13 1326 3616
Email
golshad@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Golpar Radafshar
Position
Associate Professor of Periodontics
Other areas of specialty/work
Street address
Guilan University of Medical Sciences Complex Buildings, Saravan Free way, Lakan road
City
Rasht
Postal code
4194173774
Phone
+98 13 1326 3616
Fax
+98 13 1326 3616
Email
golshad@gums.ac.ir
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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