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Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp

NCT ID: NCT05859646

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2022-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Decay Probiotics Streptococcus Mutans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessment was performed by a different researcher who was unaware of the group distributions in which patients were included.

Study Groups

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Probiotics

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

Group Type EXPERIMENTAL

Probiotic use

Intervention Type DIETARY_SUPPLEMENT

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic use

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Follow-up after general anesthesia

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Didem Sakaryali Uyar

OTHER

Sponsor Role lead

Responsible Party

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Didem Sakaryali Uyar

Asst. Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Başkent University

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 39095860 (View on PubMed)

Other Identifiers

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D-KA 19/41

Identifier Type: -

Identifier Source: org_study_id

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