Jordan University of Science and Technology
Irbid, 22110, Jordan
NCT Number: NCT03526315
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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Notify Me4 year–5 year
All sexes
Interventional
Not applicable
Irbid, 22110, Jordan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children will brush their teeth with CPP-ACP paste twice daily.
Children will brush their teeth with fluoridated toothpaste twice daily.
Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.
Time frame: 3 and 6 months
Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)
Time frame: 3 and 6 months
Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Time frame: 3 and 6 months
Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Time frame: 3 and 6 months
Changes in ICDAS scores over 3 and 6 months.
Jordan University of Science and Technology
Other
Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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