Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

Sponsor

Jordan University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT03526315

Collaborator

(none)

127

Enrollment

Location

Arms

Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mutans Streptococci Oral Health	Other: CPP-ACP paste Other: Fluoride toothpaste Other: Both (Fluoride and CPP-ACP)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

127 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 MS levels in terms of (CFU) using Saliva Check Mutans kits ( GC, Asia) for this purpose. Samples will be analyzed for MS colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.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 MS levels in terms of (CFU) using Saliva Check Mutans kits ( GC, Asia) for this purpose. Samples will be analyzed for MS colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CPP-ACP paste Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.	Other: CPP-ACP paste Children will brush their teeth with CPP-ACP paste twice daily.
Active Comparator: Fluoride toothpaste Fluoride toothpaste	Other: Fluoride toothpaste Children will brush their teeth with fluoridated toothpaste twice daily.
Active Comparator: Both (Fluoride and CPP-ACP) Fluoride toothpaste and CPP-ACP paste	Other: Both (Fluoride and CPP-ACP) Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.

Arm

Intervention/Treatment

Active Comparator: CPP-ACP paste

Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.

Other: CPP-ACP paste

Children will brush their teeth with CPP-ACP paste twice daily.

Active Comparator: Fluoride toothpaste

Fluoride toothpaste

Other: Fluoride toothpaste

Children will brush their teeth with fluoridated toothpaste twice daily.

Active Comparator: Both (Fluoride and CPP-ACP)

Fluoride toothpaste and CPP-ACP paste

Other: Both (Fluoride and CPP-ACP)

Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.