Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

J

Jordan University of Science and Technology

Status

Completed

Conditions

Mutans Streptococci
Oral Health

Treatments

Other: Fluoride toothpaste
Other: Both (Fluoride and CPP-ACP)
Other: CPP-ACP paste

Study type

Interventional

Funder types

Other

Identifiers

NCT03526315
JUST

Details and patient eligibility

About

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.

Full 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.

Enrollment

127 patients

Sex

All

Ages

4 to 5 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy 4-5 years old children, with primary dentition, and early childhood caries/high risk caries

Exclusion criteria

  • Milk protein (casein) sensitivity
  • Patient who has taken antibiotics in the last month
  • Lack in cooperation in oral examination
  • Medically compromised children
  • Children that have received fluoride supplement or professional topical fluoride application at least three months before or during the study period.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

127 participants in 3 patient groups

CPP-ACP paste
Active Comparator group
Description:
Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.
Treatment:
Other: CPP-ACP paste
Fluoride toothpaste
Active Comparator group
Description:
Fluoride toothpaste
Treatment:
Other: Fluoride toothpaste
Both (Fluoride and CPP-ACP)
Active Comparator group
Description:
Fluoride toothpaste and CPP-ACP paste
Treatment:
Other: Both (Fluoride and CPP-ACP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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