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Completed

NCT Number: NCT03547128

Iowa Fluoride Study/Iowa Bone Development Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy newborn

Exclusion criteria

  • not health newborn

Treatment and study plan

Primary outcomes

  1. dental fluorosis-5

    Time frame: age 5

    dental fluorosis exam results

  2. dental fluorosis-9

    Time frame: age 9

    dental fluorosis exam results

  3. dental fluorosis-13

    Time frame: age 13

    dental fluorosis exam results

  4. dental fluorosis-17

    Time frame: age 17

    dental fluorosis exam results

  5. dental fluorosis-23

    Time frame: age 23

    dental fluorosis exam results

  6. dental caries-5

    Time frame: age 5

    dental caries exam results

  7. dental caries-9

    Time frame: age 5

    dental caries exam results

  8. dental caries-13

    Time frame: age 9

    dental caries exam results

  9. dental caries-17

    Time frame: age 17

    dental caries exam results

  10. dental caries-23

    Time frame: age 23

    dental caries exam results

  11. bone densitometry-5

    Time frame: age 5

    DXA scans

  12. bone densitometry-8

    Time frame: age 8

    DXA scans

  13. bone densitometry-11

    Time frame: age 11

    DXA and pQCT scans

  14. bone densitometry-13

    Time frame: age 13

    DXA and pQCT scans

  15. bone densitometry-15

    Time frame: age 15

    DXA and pQCT scans

  16. bone densitometry-17

    Time frame: age 17

    DXA and pQCT scans

  17. bone densitometry-19

    Time frame: age 19

    DXA, pQCT, and MDCT scans

  18. bone densitometry-23

    Time frame: age 23

    DXA, pQCT, and MDCT scans

Sponsors and collaborators

Lead sponsor

Steven M Levy

Other

Registry information

Acronym: (IFS/IBDS)

Important dates

Study start
1992
Primary completion
1996
Study completion
2019
First posted
Jun 6, 2018
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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