Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

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

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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This study is a randomized controlled trial involving 127 children ages between 4 and 5 years to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in reducing Streptococcus mutans (S. mutans) bacteria, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP over a 6 month period using Saliva Check Mutans kits to detect Mutans Streptococci (MS). It is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans level in different values.

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Detailed Description

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Aim: The aim of this study is to investigate the efficacy of CPP-ACP in reducing S. mutans, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP.

Materials and methods: This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure S. mutans levels in terms of Colony forming units (CFU) using Saliva Check Mutans kits (GC© , Asia) for this purpose. Samples will be analyzed for S. mutans colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.

Expected results: it is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans levels in different levels.

Conditions

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Mutans Streptococci Oral Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure MS levels in terms of (CFU) using Saliva Check Mutans kits ( GC, Asia) for this purpose. Samples will be analyzed for MS colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPP-ACP paste

Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.

Group Type ACTIVE_COMPARATOR

CPP-ACP paste

Intervention Type OTHER

Children will brush their teeth with CPP-ACP paste twice daily.

Fluoride toothpaste

Group Type ACTIVE_COMPARATOR

Fluoride toothpaste

Intervention Type OTHER

Children will brush their teeth with fluoridated toothpaste twice daily.

Both (Fluoride and CPP-ACP)

Fluoride toothpaste and CPP-ACP paste

Group Type ACTIVE_COMPARATOR

Both (Fluoride and CPP-ACP)

Intervention Type OTHER

Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.

Interventions

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CPP-ACP paste

Children will brush their teeth with CPP-ACP paste twice daily.

Intervention Type OTHER

Fluoride toothpaste

Children will brush their teeth with fluoridated toothpaste twice daily.

Intervention Type OTHER

Both (Fluoride and CPP-ACP)

Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy 4-5 years old children, with primary dentition, and early childhood caries/high risk caries

Exclusion Criteria

* Milk protein (casein) sensitivity
* Patient who has taken antibiotics in the last month
* Lack in cooperation in oral examination
* Medically compromised children
* Children that have received fluoride supplement or professional topical fluoride application at least three months before or during the study period.

Minimum Eligible Age

4 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes