Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03526315
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2017-03-06
Brief Title:
Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children
Sponsor:
Jordan University of Science and Technology
Organization:
Jordan University of Science and Technology
Study Overview
Official Title:
Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None