NCT02375763

Brief Summary

Children will be recruited from the pediatric dentistry clinic of Marquette University at their first or recall appointment and will be asked to fill a questionnaire regarding their dietary habits. Afterwards a dietary analysis will be performed using a computer software, developed for this study and dietary instructions will be given to the children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

February 18, 2015

Last Update Submit

March 22, 2017

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in dietary habits at 3 months

    3 months

Study Arms (2)

Sortware suggestions

EXPERIMENTAL

Children will fill a questionnaire regarding their dietary habits. Afterwards a dietary analysis will be performed using a computer software, and dietary instructions will be given to the children.

Other: Software instruction

Traditional suggestions

PLACEBO COMPARATOR
Other: Software instruction

Interventions

Software instructionOTHER
Sortware suggestionsTraditional suggestions

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Free medical history
  • Informed Consent

You may not qualify if:

  • General disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marquette University Pediatric Dentistry Clinic

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 3, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

US(1)