Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp

May 5, 2023 updated by: Didem Sakaryali Uyar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06490
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics
Group A-Probiotics group: Patients who started using probiotic drops after general anesthesia procedure
Dietary supplement: Probiotic use
Probiotics were used for 3 months and all participated patients were followed for 6 months.
Other Names:
  • Follow-up after general anesthesia
No Intervention: Control
Group B-Control group: Patients who did not use any probiotics after general anesthesia procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S mutans count
Time Frame: 6 month
CFU
6 month
Lactobacillus spp count
Time Frame: 6 month
CFU
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Didem Sakaryali Uyar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-KA 19/41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the study is published, it can be sent to the individual upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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