NCT03547128: (IFS/IBDS)

Iowa Fluoride Study/Iowa Bone Development Study

Completed Last updated 25 February 2025

What this trial tests

trial in Dental Caries in 1,882 participants. Completed in 18 June 2019.

Timeline

1 March 1992

Primary endpoint
1 March 1996

18 June 2019

Quick facts

Lead sponsor	Steven M Levy
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,882
Start date	1 March 1992
Primary completion	1 March 1996
Estimated completion	18 June 2019

Conditions studied

• Dental Caries — all drugs for Dental Caries →
• Dental Fluoroses — all drugs for Dental Fluoroses →
• Bone Density — all drugs for Bone Density →

Sponsor

Steven M Levy

Who can join

Adults 1 Month to 30, any sex, with Dental Caries or Dental Fluoroses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beverage Intakes and Toothbrushing During Childhood Are Associated With Caries at Age 17 Years.
   Marshall TA, Curtis AM, Cavanaugh JE, Warren JJ, et al · · 2021 · cited 8× · PMID 33109505 · DOI 10.1016/j.jand.2020.08.087
2. Associations between body mass index and body composition measures in a birth cohort.
   Marshall TA, Curtis AM, Cavanaugh JE, Warren JJ, et al · · 2022 · cited 5× · PMID 33972687 · DOI 10.1038/s41390-021-01562-y
3. Interscholastic Athletics and Bone Strength: The Iowa Bone Development Study.
   Pashkova A, Hartman JM, Letuchy EM, Janz KF. · · 2022 · cited 4× · PMID 32459739 · DOI 10.1519/jsc.0000000000003646
4. Identification of and Associations among Low, Middle, and High Body Composition Trajectories from Age 5- to 17-Years.
   Marshall TA, Curtis AM, Cavanaugh JE, Warren JJ, et al · · 2020 · cited 1× · PMID 33092036 · DOI 10.3390/children7100192