Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Ultrasound | Measurement 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.