NCT03731403

Brief Summary

Remineralization effect of CPP-ACP and Fluoride (MI varnish) versus Fluoride varnish on white spot lesions in maxillary primary incisors

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

First Submitted

Initial submission to the registry

November 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

November 3, 2018

Last Update Submit

July 17, 2020

Conditions

Remineralization Effect of the Varnish on White Spot Lesions

Keywords

Early childhood cariesCasein phosphopeptides-amorphous calcium phosphatefluorideremineralization potentialvarnish

Outcome Measures

Primary Outcomes (1)

  • Caries activity

    Measured by ICDAS II

    Change from base line, after application at 3, 6, 9 last follow up 12 months

Secondary Outcomes (1)

  • Remineralization

    Change from base line, after application at 3, 6, 9 last follow up 12 months

Study Arms (2)

MI Varnish

EXPERIMENTAL
Other: MI varnish

Profluorid Varnish

ACTIVE COMPARATOR
Other: MI varnish

Interventions

MI varnishOTHER

CPP- ACP with 5 % sodium fluoride GC

Also known as: CPP- ACP with fluoride
MI VarnishProfluorid Varnish

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with white spot lesions on their incisors.
  • Age ranging 3-5 years.
  • Good general health.

You may not qualify if:

  • \. Chronic use of medications or antibiotics 2. lack of cooperation in the oral examination 3. Allergies to milk protein or benzoate preservatives 4. Presence of oral soft-tissue lesions or enamel hypoplasia at baseline examination, 5. Children who have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry- Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplexFluorides

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

November 3, 2018

First Posted

November 6, 2018

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)