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NCT05859646 Clinical Trial

Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp

Probiotics Clinical Trial

Official title:
Evaluation of Streptococcus Mutans and Lactobacillus Species Due to Probiotic Use in Oral Flora

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05859646
Other study ID # D-KA 19/41
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2020
Est. completion date May 15, 2022

Study information
Verified date May 2023
Source Baskent University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date May 15, 2022
Est. primary completion date January 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 12 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotic use
Probiotics were used for 3 months and all participated patients were followed for 6 months.

Locations
Country Name City State
Turkey Baskent University Ankara Cankaya

Sponsors (1)
Lead Sponsor Collaborator
Didem Sakaryali Uyar

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary S mutans count CFU 6 month
Primary Lactobacillus spp count CFU 6 month
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