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Completed

NCT Number: NCT03526315

Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

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.

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Key information

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPP-ACP paste

Other

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

Fluoride toothpaste

Other

Children will brush their teeth with fluoridated toothpaste twice daily.

Both (Fluoride and CPP-ACP)

Other

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

Primary outcomes

  1. Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)

    Time frame: 3 and 6 months

    Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)

Secondary outcomes

  1. Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)

    Time frame: 3 and 6 months

    Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.

  2. Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index

    Time frame: 3 and 6 months

    Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.

  3. Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores

    Time frame: 3 and 6 months

    Changes in ICDAS scores over 3 and 6 months.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 16, 2018
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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