NCT05859646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 5, 2023

Last Update Submit

May 5, 2023

Conditions

Keywords

tooth cariesprobioticsqPCRStreptococcus mutansLactobacillus

Outcome Measures

Primary Outcomes (2)

  • S mutans count

    CFU

    6 month

  • Lactobacillus spp count

    CFU

    6 month

Study Arms (2)

Probiotics

EXPERIMENTAL

Group A-Probiotics group: Patients who started using probiotic drops after general anesthesia procedure

Dietary Supplement: Probiotic use

Control

NO INTERVENTION

Group B-Control group: Patients who did not use any probiotics after general anesthesia procedure

Interventions

Probiotic useDIETARY_SUPPLEMENT

Probiotics were used for 3 months and all participated patients were followed for 6 months.

Also known as: Follow-up after general anesthesia
Probiotics

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Every included child had at least 8 tooth with caries.

You may not qualify if:

  • Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent University

Ankara, Cankaya, 06490, Turkey (Türkiye)

Location

Related Publications (1)

  • Sakaryali Uyar D, Uskudar Guclu A, Celik E, Memis Ozgul B, Altay Kocak A, Basustaoglu AC. Evaluation of probiotics' efficiency on cariogenic bacteria: randomized controlled clinical study. BMC Oral Health. 2024 Aug 2;24(1):886. doi: 10.1186/s12903-024-04659-y.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessment was performed by a different researcher who was unaware of the group distributions in which patients were included.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

January 15, 2020

Primary Completion

January 15, 2022

Study Completion

May 15, 2022

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

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

Locations