A clinical trial to compare the effectiveness of probiotics pills with fluoride mouthwash on microbial population in saliva in fixed orthodontic patients
To compare the effectiveness of probiotics pills with fluoride mouthwash on microbial population in saliva in fixed orthodontic patients
Design
Totally, 75 patients whose undergoing fixed orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran. In this double-blind, controlled clinical trial, the patients are assigned into parallel groups using simple sampling methods.
Settings and conduct
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection and clinical care is blind to group allocation and the type of drugs. Patients will receive Lacto Gum biodegradable, placebo and fluoride mouthwash for 3 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 17-18 years; no history of systemic disease; nonuse of antibiotic and probiotic drugs; The patient is in the middle of the spectrum regarding caries risk, and not high caries risk is recommended. In addition, the individual should have good oral hygiene.
Exclusion criteria: Dentinogenesis imperfect; amelogenesis imperfect; having specific metabolic diseases; bulimia nervosa; anorexia nervosa; having probiotics drug intolerance.
Intervention groups
The intervention group will receive Lacto Gum biodegradable sucker pills containing Lactobacillus salivarius produced by Biology Fermentation Company for 3 weeks. Control group one will receive sucker pills of placebo without Lactobacillus salivarius for 3 weeks. Control group two will receive fluoride mouthwash for 3 weeks.
Main outcome variables
Evaluation and comparison of the buffering power of the saliva, Streptococcus mutans and Lactobacillus population in between groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200203046363N1
Registration date:2020-03-02, 1398/12/12
Registration timing:prospective
Last update:2020-03-02, 1398/12/12
Update count:0
Registration date
2020-03-02, 1398/12/12
Registrant information
Name
Amirreza Faraji Eraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 1674
Email address
farajiar931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of probiotics pills with fluoride mouthwash on microbial population in saliva in fixed orthodontic patients
Public title
The effectiveness of probiotics pills on microbial population in orthodontic patient
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 17-18 years
No history of systemic disease
Nonuse of antibiotic and probiotic drugs
The patient is in the middle of the spectrum regarding caries risk, and not high caries risk is recommended. In addition, the individual should have good oral hygiene
Exclusion criteria:
Dentinogenesis imperfect
Amelogenesis imperfect
Having specific metabolic diseases
Bulimia nervosa
Anorexia nervosa
Having probiotics drug intolerance
Age
From 14 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into three groups of 25 patients with blocks of 2, 4, and 6 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the intervention and two control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection and clinical care are blind to group allocation and the type of drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.116
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.5
ICD-10 code description
Fitting and adjustment of ileostomy and other intestinal appliances
Primary outcomes
1
Description
Buffering power of the saliva
Timepoint
Before and 3 weeks after the intervention
Method of measurement
PH meter device
2
Description
Streptococcus mutans population
Timepoint
Before and 3 weeks after the intervention
Method of measurement
Microbial counting
3
Description
Lactobacillus population
Timepoint
Before and 3 weeks after the intervention
Method of measurement
Microbial counting
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive Lacto Gum biodegradable sucker pills containing Lactobacillus salivarius produced by Biology Fermentation Company for 3 weeks.
Category
Prevention
2
Description
Control group one will receive sucker pills of placebo without Lactobacillus salivarius produced by Biology Fermentation Company for 3 weeks.
Category
Prevention
3
Description
Control group two will receive fluoride mouthwash for 3 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Amirreza Faraji Eraghi
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
farajiar931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Faraji Eraghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3884 1674
Email
farajiar931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Faraji Eraghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3884 1674
Email
farajiar931@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Faraji Eraghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3884 1674
Email
farajiar931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Amirreza Faraji Eraghi provides the data analysis to the applicants via email: farajiar931@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.