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Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp

Sponsor
Didem Sakaryali Uyar (Other)
Overall Status
Completed
CT.gov ID
NCT05859646
Collaborator
(none)
58
Enrollment
1
Location
2
Arms
28
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic use
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 separate groups, experimental and control, 6 month follow-up period, randomized distribution2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
Masking:
Single (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.
Primary Purpose:
Prevention
Official Title:
Evaluation of Streptococcus Mutans and Lactobacillus Species Due to Probiotic Use in Oral Flora
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
Jan 15, 2022
Actual Study Completion Date :
May 15, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. S mutans count [6 month]

      CFU

    2. Lactobacillus spp count [6 month]

      CFU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Başkent University Ankara Cankaya Turkey 06490

    Sponsors and Collaborators

    • Didem Sakaryali Uyar

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Didem Sakaryali Uyar, Asst. Prof. Dr., Baskent University
    ClinicalTrials.gov Identifier:
    NCT05859646
    Other Study ID Numbers:
    • D-KA 19/41
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Didem Sakaryali Uyar, Asst. Prof. Dr., Baskent University
    tooth caries
    probiotics
    qPCR
    Streptococcus mutans
    Lactobacillus
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of May 16, 2023