Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mutans Streptococci, Oral Health

Intervention / Treatment
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* Other: CPP-ACP paste
* Other: Fluoride toothpaste
* Other: Both (Fluoride and CPP-ACP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPP-ACP paste, Fluoride toothpaste, Combined use of fluoride and CPP-ACP paste, MS reduction, Antibacterial, Children