Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

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)

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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)