Clinical trial NCT03526315: Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children
Official title: Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mutans Streptococci
Oral Health
Keywords: CPP-ACP paste
Fluoride toothpaste
Combined use of fluoride and CPP-ACP paste
MS reduction
Antibacterial
Children
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 127
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)
timeFrame: 3 and 6 months
measure: Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index
timeFrame: 3 and 6 months
measure: Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Associate Professor in Pediatric Dentistry
name: Ola Al-Batayneh, MDSc, FRACDS
role: PRINCIPAL_INVESTIGATOR
References: