Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03083444

P Gingivalis Oral Infection, Intimamedia Thickening in Infants, Atherosclerosis

Early P Gingivalis Oral Infection and Ultrasound Detection of Intimamedia Thickening in Radial Arteries of Young Children

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Creighton University · Academic / Other
Sex
All
Age
4 Months – 24 Months
Healthy volunteers
Accepted

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.

Detailed description

Specific Aim 1. To determine the presence of Pg in the mouth of edentulous pre-eruption and then teething infants. Over a 9-month period 15 normal babies will be recruited for a prospective pilot study from Creighton University students. Cotton swabs of the tongue mucosa and dental plaque will be made to detect the presence of Pg by DNA analysis. Specific Aim 2. To determine the daily temperature of infants. Daily child temperatures will be recorded by the parent. Specific Aim 3. To measure the thickness of the radial artery using a 50 MHz ultrasound probe. A 50 MHz ultrasound scan will be made by a trained dental hygienist of the left radial artery at an initial visit and at 3-monthly intervals to measure IMT.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTUltrasoundMeasurement of thickness of radial artery wall thickness by ultrasound

Timeline

Start date
2017-04-15
Primary completion
2018-11-30
Completion
2018-11-30
First posted
2017-03-20
Last updated
2018-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03083444. Inclusion in this directory is not an endorsement.