Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children
Condition: Mutans Streptococci; Oral Health
Study type: Interventional

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.
    

Intervention name(s): CPP-ACP paste; Fluoride toothpaste; Both (Fluoride and CPP-ACP)
Intervention type(s): Other; Other; Other
Intervention description(s): 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.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPP-ACP paste; Fluoride toothpaste; Combined use of fluoride and CPP-ACP paste; MS reduction; Antibacterial; Children