Protocol summary

Summary
The purpose of this study is to compare the efficacy of two chlorhexidine and Halita mouthrinses in reducing bad breath in patients referring to the Department of Oral Medicine at Tabriz University of Medical Sciences. Inclusion criteria: Organoleptic score (OLS) of over 2. Exclusion criteria: Alcohol and tobacco use; Systemic diseases; Medications that cause dry mouth; Consumption of antibiotics in the previous two weeks; Pocket depth greater than 6 mm; Eating spicy foods, onion, and garlic 48 hours prior to the examination; Use of orthodontic appliances (fixed or removable) and removable dental prosthesis; Allergy or any undesirable reactions to either of test mouthrinses. It should be noted that, during the study period, the participants did not receive dental procedures such as scaling, restoration, etc. and thus their oral health conditions were unchanged. The most important issue in treatment of bad breath is to identify the cause in order to eliminate it. An easy and low-cost way is to administer health protocols that involve the use of toothbrush, dental floss, and mouthwash. Chemical methods such as using mouthwashes are complement to mechanical methods. A large number of studies on different types of mouthwashes such as chlorhexidine, cetylpyridinium chloride, and zinc have been performed. 50 samples were randomly selected and divided into two groups of 25, with consideration for the drop-out in the current triple-blind randomized controlled clinical trial. Halita (containing 0.05% chlorhexidine, 0.05% cetylpyridinium chloride, and zinc) and chlorhexidine moutrinses (both provided by Rozhin Co., Tabriz, Iran) were prepared in 140 ml volume for 7-day use (14 doses) in blindly marked similar containers. Oral and written instructions of using the mouthrinse were given to the patients. After 7 days, patients in both groups were examined to evaluate the effects.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121520314N1
Registration date: 2015-02-23, 1393/12/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Siamand Ebrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 659 6739
Email address
aghazadehm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Rozhin Co.
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of efficacy of Halita mouthrine with chlorhexidine mouthrine in reducing oral malodor in patients with halitosis in 7-day consumption
Public title
Comparison of efficacy of Halita mouthrine with chlorhexidine mouthrine in reducing oral malodor in patients with oral malador
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Organoleptic score (OLS) of over 2. Exclusion criteria: Alcohol and tobacco use; Systemic diseases; Medications that cause dry mouth; Consumption of antibiotics in the previous two weeks; Pocket depth greater than 6 mm; Eating spicy foods, onion, and garlic 48 hours prior to the examination; Use of orthodontic appliances (fixed or removable) and removable dental prosthesis; Allergy or any undesirable reactions to either of test mouthrinses. It should be noted that, during the study period, the participants did not receive dental procedures such as scaling, restoration, etc. and thus their oral health conditions were unchanged.
Age
From 17 years old to 26 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Tabriz University of Medical Sciences
Street address
Daneshgah street
City
Tabriz
Postal code
Approval date
2013-10-25, 1392/08/03
Ethics committee reference number
939

Health conditions studied

1

Description of health condition studied
Oral halitosis
ICD-10 code
R19.6
ICD-10 code description
Halitosis

Primary outcomes

1

Description
Oral halitosis
Timepoint
before intervention and after 7 days of intervention
Method of measurement
Organoleptic measurement

Secondary outcomes

empty

Intervention groups

1

Description
0.05% chlorhexidine mouth rinse in 140 ml volume for 7-day use (14 doses) 10 ml for one dose.
Category
Treatment - Drugs

2

Description
Halita(containing 0.05% chlorhexidine, 0.05% cetylpyridinium chloride, and zinc) mouth rinse in 140 ml volume for 7-day use (14 doses) 10 ml for one dose.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr Zahra Jamali
Street address
Daneshgah street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, faculty of dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Aminabady
Street address
Daneshgah street
City
Tabriz
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, faculty of dentistry, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Siamand Ebrahimi
Position
Dentistry student
Other areas of specialty/work
Street address
Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3335 7314
Fax
+98 41 3335 9680
Email
Z.jamali55@gmail.com
Web page address
www.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Zahra Jamali
Position
Assistant professor of oral medicine
Other areas of specialty/work
Street address
Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3335 7314
Fax
+98 41 3335 9680
Email
Z.jamali55@gmail.com
Web page address
www.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Siamand Ebrahimi
Position
Dentistry student
Other areas of specialty/work
Street address
Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3544 1256
Fax
+98 41 3335 9680
Email
syamand.ebrahimy@yahoo.com
Web page address
www.tbzmed.ac.ir

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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