Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

Not Applicable

Completed

• Conditions: Mutans Streptococci; Oral Health
• Interventions: Other: CPP-ACP paste; Other: Fluoride toothpaste; Other: Both (Fluoride and CPP-ACP)

• Registration Number: NCT03526315
• Lead Sponsor: Jordan University of Science and Technology

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.

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2017-03-06
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-03
• Last Update Submitted: 2018-05-03
• Study First Posted: 2018-05-16
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPP-ACP paste	CPP-ACP paste	Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.
Fluoride toothpaste	Fluoride toothpaste	Fluoride toothpaste
Both (Fluoride and CPP-ACP)	Both (Fluoride and CPP-ACP)	Fluoride toothpaste and CPP-ACP paste

Primary Outcome Measures

Name	Time	Method
Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)	3 and 6 months	Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)

Secondary Outcome Measures

Name	Time	Method
Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index	3 and 6 months	Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores	3 and 6 months	Changes in ICDAS scores over 3 and 6 months.
Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)	3 and 6 months	Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan