Determining the effect of probiotic yogurt on the amount of Streptococcus mutans colony in children treated with fixed spacer
Design
Clinical trial with control group, with parallel groups, single blind, randomized, phase 3, 70 patients per day. Permutation block method was used for randomization.
Settings and conduct
70 adolescents aged 5 to 15 who did not have systemic disease and had not used long-term antibiotics or probiotic products recently and needed to use a fixed spacer were included in the study. Using a questionnaire, each patient's information about health, medicine, dental care and habits is recorded by a questionnaire. After explaining the implementation method to the parents and obtaining informed consent, the children who need a safe space will be randomly divided into two groups. After placing the fixed spacer, the probiotic yogurt intervention group and the normal yogurt control group received 200 grams once a day for two weeks. After placing the fixed spacer and before the intervention and two weeks after the intervention, a saliva sample was prepared and the amount of Streptococcus mutans colony was measured. The participants did not know the type of yogurt consumed
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age between 5 and 15 years
2. The use of a fixed astronaut
Exclusion criteria:
1. Unwillingness and cooperation to continue at every stage of the research
2. Failure to follow the recommended interventions
Intervention groups
intervention groups: The group receiving 200 grams of probiotic yogurt once a day
control group: The group receiving 200 grams of regular yogurt once a day
Main outcome variables
amount of Streptococcus mutans colony
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240511061731N1
Registration date:2024-06-18, 1403/03/29
Registration timing:prospective
Last update:2024-06-18, 1403/03/29
Update count:0
Registration date
2024-06-18, 1403/03/29
Registrant information
Name
maedeh babaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 382 4905
Email address
babaeimaedeh275@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-07, 1403/05/17
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic yogurt on the amount of Streptococcus mutans colony in children with fixed spacer
Public title
The effect of probiotic yogurt on Streptococcus mutans in children with fixed spacer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age between 5 and 15 years
The use of a fixed spacer
Absence of chronic disease
Not using other probiotic products
Exclusion criteria:
Unwillingness and cooperation to continue at every stage of the research
Occurrence of physical or mental problems that are not able to cooperate
Failure to follow the recommended interventions
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
They were placed in two control and intervention groups by random allocation method of block randomization. First, in order to generate a random sequence, random allocation software was used and the size of the blocks was selected (the letter A was assigned to the intervention group and the letter B was assigned to the control group, and random sequences such as AABBAB, ABBAAB, etc. were generated). After random sequence generation, each of these sequences was recorded on a card and the cards were placed inside sealed opaque envelopes. In order to maintain the random sequence, numbering was done on the outer surface of the envelopes and they were placed inside a box. Then, a lottery was conducted and each envelope was assigned to one of the blocks, and in this way, people were assigned to one of the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in the study did not know about the type of yogurt consumed
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani Street, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88155571
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
IR.SKUMS.MED.REC.1402.086
Health conditions studied
1
Description of health condition studied
Tooth Decay
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Streptococcus mutans colony rate
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
5 ml of unstimulated saliva was collected in a tube and the samples were cultured in a blood agar plate at 37°C for 48 hours in an incubator, and then the number of Streptococcus mutans colonies was measured.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group receiving Kalleh Lactivia probiotic Yoghurt 200 grams daily for two weeks
Category
Treatment - Other
2
Description
Control group: The group receiving regular Kalleh Yoghurt 200 grams daily for two weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord University of Medical Sciences Dental Clinic
Full name of responsible person
maedeh babaei
Street address
Challenger, Rahbar Blvd., Resalat Square, Faculty of Dentistry
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3232 2400
Email
info@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
fatemeh naderi
Street address
Shahrekord, Kashani Boulevard, Shahrekord University of Medical Sciences
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Maedeh Babaei
Position
Dentistry student
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Shahrekord, Moalem Blvd., Mujahidhan Street, 34
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817917135
Phone
+98 913 382 4905
Fax
Email
babaeimaedeh275@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
maedeh babaei
Position
Dental student
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Shahrekord, Moalem Blvd., Mujahidhan Street, 34
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817917135
Phone
+98 38 24905
Email
babaeimaedeh275@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maedeh Babaei
Position
Dentistry student
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Shahrekord, Moalem Blvd., Mujahidhan Street, 34
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817917135
Phone
+98 913 382 4905
Fax
Email
babaeimaedeh275@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available