NCT03083444

Brief Summary

To determine if there is an association between Porphyromonas gingivalis infection of dental gingiva during primary tooth eruption and thickening of the radial artery intimamedial layers. Thickening of these layers in infants could be a promoting factor for later development of atherosclerosis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

March 14, 2017

Last Update Submit

January 23, 2018

Conditions

Tooth Eruption, Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Arterial wall thickness

    Increase in thickness of intimamedia layers

    9 months

Interventions

UltrasoundDIAGNOSTIC_TEST

Measurement of thickness of radial artery wall thickness by ultrasound

Eligibility Criteria

Age4 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants 4- 24 months of age.

You may qualify if:

  • Pre-primary tooth eruption infants in the range of 4-8 months -

You may not qualify if:

  • No erupted teeth. No diabetes, obesity, chronic inflammatory disorders, hyperlipidemia, -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University School of Dentistry

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

ExanthemaAtherosclerosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Douglas Benn, DDS PhD

    Creighton University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 20, 2017

Study Start

April 15, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)