This study is of clinical trials to determine the effect of mouthwashes containing green tea extract on the severity of halitosis in patients with this problem. A total of 42 patients with oral malodor referred to Department of Periodontics, School of Dentistry, Isfahan University of Medical Sciences were first examined clinically, and when approved the disease, included in the study. Smoking patients and those with systemic diseases considered as confounding factors in the study were excluded and replaced. Patients enrolled in the study were divided into two intervention (21 individuals) and control groups (21 individuals) based on a table of random numbers and in the form of double-blind trial (scholars and patients). The severity of halitosis was determined in both groups by organoleptic method. Patients in the intervention group and those in the control group used the mouthwash containing green tea and the placebo, respectively, twice a day (morning and late at night) each time for 30 seconds, for a week. Patients were trained the modified brushing Bass technique in order to eliminate the confounding factors. The intensity of halitosis was re-measured in patients using organoleptic method, and its changes were compared with the primary state. The improvement was expected in the severity of halitosis in both the intervention and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012026122N1
Registration date:2016-02-25, 1394/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-25, 1394/12/06
Registrant information
Name
Parichehr Behfarnia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 4520 7244
Email address
behfarniaa@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-02-27, 1394/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of mouthwashes containing green tea on the severity of halitosis in patients with halitosis
Public title
Comparison of the effectiveness of mouthwashes containing green tea on the severity of halitosis in patients with halitosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who complain of oral malodor; Patients who their halitosis will be confirmed after clinical examination.
Exclusion criteria:
Patients who were not willing to participate in the study; female patients in their period of menstruation; smoking people; those with systemic diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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 Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Approval date
2014-12-22, 1393/10/01
Ethics committee reference number
394501
Health conditions studied
1
Description of health condition studied
oral malodor
ICD-10 code
R19.6
ICD-10 code description
halitosis
Primary outcomes
1
Description
oral halitosis with organoleptic method
Timepoint
before intervention, one weak after intervention
Method of measurement
Fundamentals of Organoleptic method: The patient will be asked to keep his/her mouth closed for two minutes and then exhale out the air. To determine the severity of the oral malodor, the researcher will measure the severity of the patient’s halitosis from the distance of 10 cm. and 50 cm., and then the severity of patient’s halitosis is classified as following five categories based on the organoleptic method: 0 = no smell of halitosis, 1= low, 2= moderate, 3= severe, 4 = very intense smell
Secondary outcomes
empty
Intervention groups
1
Description
using from green tea mouth wash for one week two times a day in intervention group
Category
Treatment - Drugs
2
Description
using placebo mouth wash for one week two times a day in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics Department of School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezarjarib street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller of 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
Isfahan University of Medical Science
Full name of responsible person
Parichehr Behfarnia
Position
Department of Periodontics and Torabinejad Research Center, School of Dentistry, Isfahan University
Other areas of specialty/work
Street address
Department of Periodontics , School of Dentistry, Isfahan University of Medical Sciences. Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3625 0466
Fax
Email
behfarniaa@dnt.mui.ac.ir rnazeria@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Periodontist, Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontics , School of Dentistry, Isfahan University of Medical Sciences. Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3625 0466
Fax
Email
behfarniaa@dnt.mui.ac.ir rnazeria@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rahman Nazeri
Position
General Dentist
Other areas of specialty/work
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezarjarib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 4520 7244
Fax
Email
rnazeria@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)