NCT03547128

Brief Summary

A cohort of newborns was recruited for the Iowa Fluoride Study from 1992-95 to assess the complex relationships among fluoride intakes, fluoride exposures, dental fluorosis, and dental caries. Detailed questionnaires were sent every 1.5-6 months concerning water sources, fluoride exposures, dietary intakes, etc. Standardized dental exams were conducted at \~ages 5, 9, 13, 17, and 23. At about age 5, participants were invited to join the offshoot Iowa Bone Development Study. Bone densitometry assessments were conducted at ages 5, 8, 11, 13, 15, 17, 19, and 23. These included Dual-energy X-ray Absorptiometry (DXA) of hip, lumbar spine, and whole body from age 5; peripheral Quantitative Computed Tomography (pQCT) of the radius and tibia from age 11; and Multi-Detector Computed Tomography (MDCT) of the tibia from age 19. Physical activity and other factors also were assessed longitudinally.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,882

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1992

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1992

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1996

Completed
21.9 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

January 11, 2018

Last Update Submit

February 21, 2025

Conditions

Dental CariesDental FluorosesBone Density

Keywords

fluoridegeneticsphysical activitydiet

Outcome Measures

Primary Outcomes (18)

  • dental fluorosis-5

    dental fluorosis exam results

    age 5

  • dental fluorosis-9

    dental fluorosis exam results

    age 9

  • dental fluorosis-13

    dental fluorosis exam results

    age 13

  • dental fluorosis-17

    dental fluorosis exam results

    age 17

  • dental fluorosis-23

    dental fluorosis exam results

    age 23

  • dental caries-5

    dental caries exam results

    age 5

  • dental caries-9

    dental caries exam results

    age 5

  • dental caries-13

    dental caries exam results

    age 9

  • dental caries-17

    dental caries exam results

    age 17

  • dental caries-23

    dental caries exam results

    age 23

  • bone densitometry-5

    DXA scans

    age 5

  • bone densitometry-8

    DXA scans

    age 8

  • bone densitometry-11

    DXA and pQCT scans

    age 11

  • bone densitometry-13

    DXA and pQCT scans

    age 13

  • bone densitometry-15

    DXA and pQCT scans

    age 15

  • bone densitometry-17

    DXA and pQCT scans

    age 17

  • bone densitometry-19

    DXA, pQCT, and MDCT scans

    age 19

  • bone densitometry-23

    DXA, pQCT, and MDCT scans

    age 23

Study Arms (1)

Parents with newborns recruited from 1992-5

Parents of newborns recruited from 8 Iowa hospitals in 1992-5

Eligibility Criteria

Age1 Month - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

newborns recruited from 8 Iowa hospitals postpartum

You may qualify if:

  • healthy newborn

You may not qualify if:

  • not health newborn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Marshall TA, Curtis AM, Cavanaugh JE, Warren JJ, Levy SM. Beverage Intakes and Toothbrushing During Childhood Are Associated With Caries at Age 17 Years. J Acad Nutr Diet. 2021 Feb;121(2):253-260. doi: 10.1016/j.jand.2020.08.087. Epub 2020 Oct 24.

    PMID: 33109505DERIVED

  • Marshall TA, Curtis AM, Cavanaugh JE, Warren JJ, Levy SM. Child and Adolescent Sugar-Sweetened Beverage Intakes Are Longitudinally Associated with Higher Body Mass Index z Scores in a Birth Cohort Followed 17 Years. J Acad Nutr Diet. 2019 Mar;119(3):425-434. doi: 10.1016/j.jand.2018.11.003. Epub 2019 Jan 9.

    PMID: 30638821DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

salivary samples collected for DNA

MeSH Terms

Conditions

Dental CariesFluorosis, DentalMotor Activity

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Steven M Levy, dds

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2018

First Posted

June 6, 2018

Study Start

March 1, 1992

Primary Completion

March 1, 1996

Study Completion

June 18, 2019

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

some data are available in NIH repository under DBGap

Time Frame
some past data are there now caries outcomes and explanatory factors
Access Criteria
contact PI for discussions and permissions