P Gingivalis Oral Infection, Intimamedia Thickening in Infants, Atherosclerosis

Tooth Eruption, Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03083444
• Other study ID #: 925229-1
• Status: Withdrawn
• Phase: N/A
• First received: March 14, 2017
• Last updated: January 23, 2018
• Start date: April 15, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2018
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 24 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Atherosclerosis
• Tooth Eruption, Atherosclerosis

Intervention

Diagnostic Test:
• Ultrasound
Measurement of thickness of radial artery wall thickness by ultrasound

Locations

Country	Name	City	State
United States	Creighton University School of Dentistry	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial wall thickness	Increase in thickness of intimamedia layers	9 months