NCT05442320

Brief Summary

To determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. In addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

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

January 3, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2014

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
Last Updated

July 5, 2022

Status Verified

December 1, 2021

Enrollment Period

4.2 years

First QC Date

December 3, 2021

Last Update Submit

June 29, 2022

Conditions

Fluorosis, Dental

Keywords

Dental fluorosisFingernails fluoride concentrationFluoride toothpaste concentration

Outcome Measures

Primary Outcomes (1)

  • Dental fluorosis

    Dean index

    6 years after permanent incisor eruption

Secondary Outcomes (1)

  • Fingernails fluoride concentration

    4 years of age

Other Outcomes (1)

  • Caries in primary dentition

    4 years of age

Study Arms (2)

500 ppm

ACTIVE COMPARATOR

Toothpaste with 500 ppm fluoride (Biodent, Ilirija d.d)

Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)

1000 ppm

EXPERIMENTAL

Toothpaste with 1000 ppm fluoride (Biodent, Ilirija d.d)

Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)

Interventions

Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)DEVICE

Toothpaste with 500 or 1000 ppm of fluoride

1000 ppm500 ppm

Eligibility Criteria

Age0 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • participation in parenting class
  • normal pregnancy

You may not qualify if:

  • chronic systemic diseases
  • genetic conditions
  • complications at delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fluorosis, Dental

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Same packages of toothpastes with different concentration Key known only to principal investigator
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two parallel groups with different toothpaste fluoride concentrations (500 ppm, 1000 ppm)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2021

First Posted

July 5, 2022

Study Start

January 3, 2010

Primary Completion

March 5, 2014

Study Completion

April 20, 2021

Last Updated

July 5, 2022

Record last verified: 2021-12