This single-blind clinical trial aims to investigate the effect of probiotic yogurt mouthwash on salivary pH of 40 patients 14-17 years old with both jaws fixed orthodontic appliances. Exclusion criteria includes tooth decay, systemic and gum diseases, the use of steroids and other drugs, smoking and pregnancy. Patients are randomly divided into two groups with table of random numbers. Yogurts are given in similar packages to the patients. During the first period, patients in both groups will not use yogurt for a week. The intervention group receives 20 mL probiotic yogurt (20.000.000 colony/gram Lactobacillus acidophilus and Bifidobacterium lactis) and the control groups receives 20 mL nonprobiotic yogurt after brushing and flossing 2 times daily for 2 weeks for one minute mouthwash, and then avoid mouth washing, eating and drinking for one hour and then wash their mouth. The third period is 2 weeks rest and the patients avoid the consumption of yogurt. In the fourth period, patients in the intervention group receive nonprobiotic yogurt and the control group patients receive probiotic yogurt twice daily for 2 weeks. At the beginning and end of 2nd and 4th period, salivary pH of all patients are measured by labtron ph meter made by Labtron co. Iran. At 10-11 am, unstimulated saliva samples are collected. pH 5 to 5.8 is very acidic, 6 to 6.6 relatively acidic and pH of 6.8 to 7.8 indicates healthy saliva.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040533236N1
Registration date:2017-07-25, 1396/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
Nafiseh Zarenejad
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
nzarenejad@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of probiotic yogurt mouthwash on salivary pH in orthodontic patient in sari dentistry school clinic
Public title
The effect of probiotic yogurt mouthwash on salivary pH
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 14-17 years; fixed orthodontic treatment of jaw distance of at least 3 months of treatment
Exclusion criteria: Dental decay; systemic diseases; Any disease of the gums and teeth; Systemic corticosteroid and other medications including antibiotics; Chlorhexidine mouthwash; Xylitol gum chewing during the past 4 weeks; smoking; Pregnancy; OCP
Age
From 14 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Moallem square, Sari, Iran
City
Sari
Postal code
4815838447
Approval date
2016-10-25, 1395/08/04
Ethics committee reference number
IR.MAZUMS.REC.95.2122
Health conditions studied
1
Description of health condition studied
Fixed orthodontic for teeth
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Salivary pH
Timepoint
Start of treatment, at the end of 1st, 2nd, 3rd and 4th course
Method of measurement
pH meter
Secondary outcomes
empty
Intervention groups
1
Description
The control group receives 20 mL nonprobiotic yogurt mouthwash twice daily for 2 weeks.
Category
Placebo
2
Description
The intervention group receives 20 mL probiotic yogurt (20.000.000 colony/gram Lactobacillus acidophilus and Bifidobacterium lactis) after brushing and flossing 2 times daily for 2 weeks for one minute mouthwash
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Sciences
Full name of responsible person
Nafiseh Zarenejad
Street address
Next to Tooba Clinic, Faculty of Dentistry, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmadali Enayati
Street address
Vice chancellor for research of Mazandaran University of Medical Sciences, Moallem Square, Sari
City
Sari
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 of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Nafiseh Zarenejad
Position
Assistant Professor
Other areas of specialty/work
Street address
Next to Tooba Clinic, Faculty of Dentistry
City
Sari
Postal code
4815838447
Phone
+98 11 3330 0000
Fax
Email
nzarenejad@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nafiseh Zarenejad
Position
Assistant Professor, Tooth Restoration Specialist
Other areas of specialty/work
Street address
Next to Tooba Clinic, Faculty of Dentistry, Sari
City
Sari
Postal code
4815838447
Phone
+98 11 3334 2334
Fax
Email
nzarenejad@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nazanin Ghobadi
Position
Student
Other areas of specialty/work
Street address
Sari
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)