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

Sponsor

Steven M Levy (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03547128

Collaborator

(none)

1,882

Enrollment

374

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Dental Fluoroses Bone Density

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

1882 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Iowa Fluoride Study/Iowa Bone Development Study

Actual Study Start Date :

Mar 1, 1992

Actual Primary Completion Date :

Mar 1, 1996

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Parents with newborns recruited from 1992-5 Parents of newborns recruited from 8 Iowa hospitals in 1992-5

Outcome Measures

Primary Outcome Measures

dental fluorosis-5 [age 5]
dental fluorosis exam results
dental fluorosis-9 [age 9]
dental fluorosis exam results
dental fluorosis-13 [age 13]
dental fluorosis exam results
dental fluorosis-17 [age 17]
dental fluorosis exam results
dental fluorosis-23 [age 23]
dental fluorosis exam results
dental caries-5 [age 5]
dental caries exam results
dental caries-9 [age 5]
dental caries exam results
dental caries-13 [age 9]
dental caries exam results
dental caries-17 [age 17]
dental caries exam results
dental caries-23 [age 23]
dental caries exam results
bone densitometry-5 [age 5]
DXA scans
bone densitometry-8 [age 8]
DXA scans
bone densitometry-11 [age 11]
DXA and pQCT scans
bone densitometry-13 [age 13]
DXA and pQCT scans
bone densitometry-15 [age 15]
DXA and pQCT scans
bone densitometry-17 [age 17]
DXA and pQCT scans
bone densitometry-19 [age 19]
DXA, pQCT, and MDCT scans
bone densitometry-23 [age 23]
DXA, pQCT, and MDCT scans

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy newborn

Exclusion Criteria:

not health newborn

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Steven M Levy

Investigators

Principal Investigator: Steven M Levy, dds, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven M Levy, Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT03547128

Other Study ID Numbers:

199112665

First Posted:

Jun 6, 2018

Last Update Posted:

May 12, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Steven M Levy, Professor, University of Iowa

Additional relevant MeSH terms:

Dental Caries

Fluorosis, Dental

Study Results

No Results Posted as of May 12, 2022