Back to resultsEffects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp
Primary Purpose
Tooth Decay, Probiotics, Streptococcus Mutans
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Probiotic use
Sponsored by
About this trial
This is an interventional prevention trial for Tooth Decay focused on measuring tooth caries, probiotics, qPCR, Streptococcus mutans, Lactobacillus
Eligibility Criteria
Inclusion Criteria: Every included child had at least 8 tooth with caries. Exclusion Criteria: Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.
Sites / Locations
- Başkent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Probiotics
Control
Arm Description
Group A-Probiotics group: Patients who started using probiotic drops after general anesthesia procedure
Group B-Control group: Patients who did not use any probiotics after general anesthesia procedure
Outcomes
Primary Outcome Measures
S mutans count
CFU
Lactobacillus spp count
CFU
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05859646
Brief Title
Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp
Official Title
Evaluation of Streptococcus Mutans and Lactobacillus Species Due to Probiotic Use in Oral Flora
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Didem Sakaryali Uyar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period.
Detailed Description
Fifthy-eight pediatric patients without any systemical diseases whose dental treatments were completed under general anesthesia were included in the study. The study was carried out as two-groups; Group A: Patients who started using probiotics after general anesthesia and Group B: Patients who did not use probiotics after general anesthesia. The counts of S. mutans and Lactobacillus spp. were determined by quantitative polymerase chain reaction (qPCR) by analysis of saliva samples taken from all patients on the day before the general anesthesia (T0), at 1-month (T1), 3-month (T2) and 6-month (T3) follow-up periods. The statistical significance level was accepted as p<0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay, Probiotics, Streptococcus Mutans
Keywords
tooth caries, probiotics, qPCR, Streptococcus mutans, Lactobacillus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
Masking
Outcomes Assessor
Masking Description
The outcome assessment was performed by a different researcher who was unaware of the group distributions in which patients were included.
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Group A-Probiotics group: Patients who started using probiotic drops after general anesthesia procedure
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group B-Control group: Patients who did not use any probiotics after general anesthesia procedure
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic use
Other Intervention Name(s)
Follow-up after general anesthesia
Intervention Description
Probiotics were used for 3 months and all participated patients were followed for 6 months.
Primary Outcome Measure Information:
Title
S mutans count
Description
CFU
Time Frame
6 month
Title
Lactobacillus spp count
Description
CFU
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Every included child had at least 8 tooth with caries.
Exclusion Criteria:
Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.
Facility Information:
Facility Name
Başkent University
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06490
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After the study is published, it can be sent to the individual upon reasonable request.
Learn more about this trial
Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp
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