NCT03526276

Brief Summary

This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
Last Updated

May 16, 2018

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

March 6, 2017

Last Update Submit

May 3, 2018

Conditions

White Spot Lesion of Tooth

Keywords

Quantitative Laser Fluorescence (QLF)CPP-ACP pasteFluoride toothpasteCombined use of fluoride and CPP-ACP pastePrimary teeth

Outcome Measures

Primary Outcomes (1)

  • Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine

    Change in remineralization of white spot lesions as indicated by changes in fluorescence levels detected by QLF after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.

    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 pasteOTHER

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

CPP-ACP paste
Fluoride toothpasteOTHER

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 toothbrushing, twice daily.

Both (Fluoride and CPP-ACP)

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy 4-5 years old children, with primary dentition, and early white spot lesions

You may not qualify if:

  • Lack of cooperation in the oral examination.
  • Allergies to milk protein.
  • Have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.
  • Medically compromised patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

MeSH Terms

Interventions

Fluoridescasein phosphopeptide-amorphous calcium phosphate nanocomplex

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Officials

  • Ola Al-Batayneh, MDSc, FRACDS

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial involving 118 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. Children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoridated toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Quantitative assessment of white spot lesions will be carried out using QLF before remineralizing agent application (baseline) and at 3, and 6 month intervals.
Sponsor Type
OTHER
Responsible Party
SPONSOR

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: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)