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Outcome Measures

Primary Outcomes (2)

Salivary load of Streptococcus mutans
Change in salivary Streptococcus mutans load from baseline to 4 weeks after the intervention, measured using quantitative real-time polymerase chain reaction (qRT-PCR).
Baseline and 4 weeks after intervention
Salivary load of Lactobacillus acidophilus
Change in salivary Lactobacillus acidophilus load from baseline to 4 weeks after the intervention, measured using quantitative real-time polymerase chain reaction (qRT-PCR).
Baseline and 4 weeks after intervention

Secondary Outcomes (3)

Clinical evaluation of plaque accumulation using Oral Hygiene Index Simplified
Baseline and 4 weeks after intervention
Evaluation of Salivary pH.
Baseline and 4 weeks after intervention
Evaluation of Buffering capacity
Baseline and 4 weeks after intervention

Study Arms (3)

Probiotic Lozenges Group

EXPERIMENTAL

Participants will receive oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei. Lozenges will be administered once daily at home for 4 weeks.

Dietary Supplement: Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei

Xylitol Lozenges Group

ACTIVE COMPARATOR

Participants will receive xylitol-based moisturizing lozenges once daily at home for 4 weeks.

Dietary Supplement: Xylitol-based moisturizing lozenges

No Lozenges Group

NO INTERVENTION

Interventions

Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracaseiDietary supplement

Participants in this group will receive oral probiotics lozenge for daily consumption for 28 days ,once a day (probiotic containing mainly Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei). Participants will be instructed to maintain standard oral hygiene practices using fluoridated toothpaste.

Also known as: SUPERTEETH DENTAL PROBIOTIC

Probiotic Lozenges Group

Xylitol-based moisturizing lozengesDietary supplement

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

The study is single-blinded approach reduces performance bias by ensuring that the microbiologist and statisticians are unaware of the treatment assignments. This maintains objectivity and minimizes behavior influenced by treatment expectations.

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: This study uses a parallel assignment model in which participants are randomly allocated into three groups: An experimental group receiving probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei once daily for four weeks. A positive control group receiving xylitol-based moisturizing lozenges. A negative control group receiving no lozenges. All participants will follow standardized oral hygiene instructions throughout the study.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Master's Student

Evaluation of the Antibacterial Effect of Probiotics on Cariogenic Bacteria in Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

Probiotic Lozenges Group

Xylitol Lozenges Group

No Lozenges Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

Probiotic Lozenges Group

Xylitol Lozenges Group

No Lozenges Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations