Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03526315

Enrollment

127

Registered

2018-05-16

Start date

2016-03-31

Completion date

2016-10-31

Last updated

2018-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mutans Streptococci, Oral Health

Keywords

CPP-ACP paste, Fluoride toothpaste, Combined use of fluoride and CPP-ACP paste, MS reduction, Antibacterial, Children

Brief summary

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.

Detailed description

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.

Interventions

OTHERCPP-ACP paste

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

OTHERFluoride toothpaste

Children will brush their teeth with fluoridated toothpaste twice daily.

OTHERBoth (Fluoride and CPP-ACP)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

4 Years to 5 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)	3 and 6 months	Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)

Secondary

Measure	Time frame	Description
Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)	3 and 6 months	Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index	3 and 6 months	Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores	3 and 6 months	Changes in ICDAS scores over 3 and 6 months.

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026