Iowa Fluoride Study/Iowa Bone Development Study ((IFS/IBDS))

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries; Bone Density; Dental Fluoroses

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1882

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

newborns recruited from 8 Iowa hospitals postpartum

Description

Inclusion Criteria:

• healthy newborn

Exclusion Criteria:

• not health newborn

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Parents with newborns recruited from 1992-5; Parents of newborns recruited from 8 Iowa hospitals in 1992-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Steven M Levy
• Investigators: Principal Investigator: Steven M Levy, dds, University of Iowa

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 1992
• Primary Completion (Actual): March 1, 1996
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; genetics; fluoride; diet
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Dental Caries; Fluorosis, Dental
• Other Study ID Numbers: 199112665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: some data are available in NIH repository under DBGap

IPD Sharing Time Frame

some past data are there now

caries outcomes and explanatory factors

• IPD Sharing Access Criteria: contact PI for discussions and permissions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No