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
| Type | Name | Description |
|---|---|---|
| OTHER | CPP-ACP paste | Children will brush their teeth with CPP-ACP paste twice daily. |
| OTHER | Fluoride toothpaste | Children will brush their teeth with fluoridated toothpaste twice daily. |
| OTHER | Both (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.