Dental Caries(IFS/IBDS)NCT03547128
Iowa Fluoride Study/Iowa Bone Development Study
An observational study of Dental Caries and Dental Fluoroses, run by Steven M Levy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Fluoroses, Bone Density
- How many people
- 1,882 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 1992to 18 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: newborns recruited from 8 Iowa hospitals postpartum
Who may be able to join
- healthy newborn
Who cannot join
- not health newborn
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.
Read the 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.
- Conditions
- Dental Caries, Dental Fluoroses, Bone Density
- Keywords
- fluoride, genetics, physical activity, diet
- Medical subject headings
- Dental Caries, Fluorosis, Dental, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parents with newborns recruited from 1992-5 | Parents of newborns recruited from 8 Iowa hospitals in 1992-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental fluorosis-5
dental fluorosis exam results
Measured: age 5
dental fluorosis-9
dental fluorosis exam results
Measured: age 9
dental fluorosis-13
dental fluorosis exam results
Measured: age 13
dental fluorosis-17
dental fluorosis exam results
Measured: age 17
dental fluorosis-23
dental fluorosis exam results
Measured: age 23
dental caries-5
dental caries exam results
Measured: age 5
dental caries-9
dental caries exam results
Measured: age 5
dental caries-13
dental caries exam results
Measured: age 9
dental caries-17
dental caries exam results
Measured: age 17
dental caries-23
dental caries exam results
Measured: age 23
bone densitometry-5
DXA scans
Measured: age 5
bone densitometry-8
DXA scans
Measured: age 8
bone densitometry-11
DXA and pQCT scans
Measured: age 11
bone densitometry-13
DXA and pQCT scans
Measured: age 13
bone densitometry-15
DXA and pQCT scans
Measured: age 15
bone densitometry-17
DXA and pQCT scans
Measured: age 17
bone densitometry-19
DXA, pQCT, and MDCT scans
Measured: age 19
bone densitometry-23
DXA, pQCT, and MDCT scans
Measured: age 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Mar 1992
- Primary completion1 Mar 1996
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven M Levy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven M Levy, University of Iowa
- Investigators
- Steven M Levy, dds, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547128
- Sponsor's protocol ID
- 199112665
- Acronym
- (IFS/IBDS)
- Status last verified
- Feb 2025
- First submitted
- 11 Jan 2018
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: some data are available in NIH repository under DBGap
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.
PubMed 33109505Marshall 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.
PubMed 30638821
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iowa Fluoride Study/Iowa Bone Development Study
- ClinicalTrials.gov ID
- NCT03547128
- Acronym / sponsor ID
- (IFS/IBDS) / 199112665
- Conditions
- Dental Caries, Dental Fluoroses, Bone Density
- Keywords
- fluoride, genetics, physical activity, diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,882 participants (actual)
- Lead sponsor
- Steven M LevyUniversity, hospital or other
- Study start
- 1 Mar 1992 (actual)
- Primary completion
- 1 Mar 1996 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents with newborns recruited from 1992-5 | – | –Parents of newborns recruited from 8 Iowa hospitals in 1992-5 |
Who may qualify
- Ages
- 1 month to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- newborns recruited from 8 Iowa hospitals postpartum
Key inclusion criteria (1 listed)
- healthy newborn
Key exclusion criteria (1 listed)
- not health newborn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
dental fluorosis-5
Time frame: age 5
dental fluorosis exam results
dental fluorosis-9
Time frame: age 9
dental fluorosis exam results
dental fluorosis-13
Time frame: age 13
dental fluorosis exam results
dental fluorosis-17
Time frame: age 17
dental fluorosis exam results
dental fluorosis-23
Time frame: age 23
dental fluorosis exam results
dental caries-5
Time frame: age 5
dental caries exam results
dental caries-9
Time frame: age 5
dental caries exam results
dental caries-13
Time frame: age 9
dental caries exam results
dental caries-17
Time frame: age 17
dental caries exam results
dental caries-23
Time frame: age 23
dental caries exam results
bone densitometry-5
Time frame: age 5
DXA scans
bone densitometry-8
Time frame: age 8
DXA scans
bone densitometry-11
Time frame: age 11
DXA and pQCT scans
bone densitometry-13
Time frame: age 13
DXA and pQCT scans
bone densitometry-15
Time frame: age 15
DXA and pQCT scans
bone densitometry-17
Time frame: age 17
DXA and pQCT scans
bone densitometry-19
Time frame: age 19
DXA, pQCT, and MDCT scans
bone densitometry-23
Time frame: age 23
DXA, pQCT, and MDCT scans
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Derived from this study: PubMed 33109505Marshall 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.
- Derived from this study: PubMed 30638821Marshall 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.
- Individual participant dataSharing planned: Yes. some data are available in NIH repository under DBGap
Related trials for Dental Caries
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M Levy, dds principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Dental Fluoroses, run by Steven M Levy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dental fluorosis-5 (time frame: age 5). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547128, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.