Comparison of the effect of probiotic tablets and probiotic enriched yogurt on halitosis
Design
This is a randomized clinical trial, phase 2-3 is in the form of a crossover. This single-blinded study will be conducted on 42 patients diagnosed with halitosis eligible to participate in the study. A randomized Simple randomization method is used for randomization and participants are assigned to two intervention groups.
Settings and conduct
This study, which will be conducted in the dental clinic of Kermanshah city, is single-blinded, and the outcome evaluators are kept blind to the allocation of the study groups. Before the intervention, the halitosis is measured by a Halimeter. After the 14-day period, the halitosis is recorded by the Halimeter, and after a 14-day rest period, the groups are switched and this time the first group consumes the probiotic yogurt and vice versa.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Acknowledgment of halitosis that has been confirmed by the examiner or the person's relatives; Informed consent; At least 15 years old; Maintaining oral hygiene in the form of brushing at least once a day
Exclusion criteria: Cigarette and tobacco smoking; Suffering from systemic and digestive diseases; Pregnancy and breastfeeding; Sinusitis and respiratory diseases; Allergy to dairy products; Complete toothlessness
Intervention groups
The first intervention group dissolves a probiotic pill in the mouth at night after brushing and then eats it for 14 days.
The second intervention group consumes 100 ml of probiotic yogurt once a day after a meal for 14 days.
Main outcome variables
Halitosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N193
Registration date:2023-01-27, 1401/11/07
Registration timing:prospective
Last update:2023-01-27, 1401/11/07
Update count:0
Registration date
2023-01-27, 1401/11/07
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-11, 1401/11/22
Expected recruitment end date
2023-05-12, 1402/02/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of probiotic tablets and probiotic enriched yogurt on halitosis :a crossover clinical trial
Public title
Comparison of the effect of probiotic tablets and probiotic enriched yogurt on halitosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acknowledgment of real bad breath that has been confirmed by the examiner or the person's relatives
Informed consent
At least 15 years old
Maintaining oral hygiene in the form of brushing at least once a day
Exclusion criteria:
Cigarette and tobacco smoking
Suffering from systemic and digestive diseases
Pregnancy and breastfeeding
Sinusitis and respiratory diseases
Allergy to dairy products
Complete toothlessness
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen from outside. One of the colleagues of the plan is asked to remove one card from the container at a time. The names of the 21 cards that are selected first are placed in the first intervention group, the second 21 selected cards are placed in the second intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessors are blinded to the study group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-01-03, 1401/10/13
Ethics committee reference number
IR.KUMS.REC.1401.412
Health conditions studied
1
Description of health condition studied
Halitosis
ICD-10 code
R19.6
ICD-10 code description
Halitosis
Primary outcomes
1
Description
Halitosis
Timepoint
The beginning of the study, 14 days after the start of the intervention, the end of the study (28 days after the intervention)
Method of measurement
Using a Holimeter
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group dissolves a probiotic pill in the mouth at night after brushing and then eats it for 14 days.
Category
Treatment - Other
2
Description
The second intervention group consumes 100 ml of probiotic yogurt once a day after a meal for 14 days
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Negar Eyvazi
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
ng.eyvazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negar Eyvazi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
ng.eyvazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Narges Ziaei
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
n.ziaei@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negar Eyvazi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
ng.eyvazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD