Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

NCT03526315 | Completed

• 1 other identifier: JUST
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Mutans Streptococci; Oral Health

Keywords

CPP-ACP paste; Fluoride toothpaste; Combined use of fluoride and CPP-ACP paste; MS reduction; Antibacterial; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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 caries using the International Caries Detection and Assessment System (ICDAS) scores

  3 and 6 months

Study Arms (3)

CPP-ACP paste

ACTIVE COMPARATOR

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

Other: CPP-ACP paste

Fluoride toothpaste

ACTIVE COMPARATOR

Fluoride toothpaste

Other: Fluoride toothpaste

Both (Fluoride and CPP-ACP)

ACTIVE COMPARATOR

Fluoride toothpaste and CPP-ACP paste

Other: Both (Fluoride and CPP-ACP)

Interventions

CPP-ACP paste OTHER

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

CPP-ACP paste

Fluoride toothpaste OTHER

Children will brush their teeth with fluoridated toothpaste twice daily.

Fluoride toothpaste

Both (Fluoride and CPP-ACP) OTHER

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

Both (Fluoride and CPP-ACP)

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy 4-5 years old children, with primary dentition, and early childhood caries/high risk caries

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

MeSH Terms

Interventions

Fluorides; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• Ola Al-Batayneh, MDSc, FRACDS

  Associate Professor in Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: May 16, 2018
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)