Clinical Trials Directory

Trials / Completed

CompletedNCT03526315

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
Phase
N/A
Study type
Interventional
Enrollment
127 (actual)
Sponsor
Jordan University of Science and Technology · Academic / Other
Sex
All
Age
4 Years – 5 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCPP-ACP pasteChildren will brush their teeth with CPP-ACP paste twice daily.
OTHERFluoride toothpasteChildren 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.

Timeline

Start date
2016-03-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2018-05-16
Last updated
2018-05-16

Locations

1 site across 1 country: Jordan

Source: ClinicalTrials.gov record NCT03526315. Inclusion in this directory is not an endorsement.