Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00098267
Other study ID # 050051
Secondary ID 05-D-0051
Status Completed
Phase N/A
First received July 12, 2006
Last updated June 30, 2017
Start date December 2, 2004
Est. completion date August 3, 2009

Study information

Verified date August 3, 2009
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will explore how bacteria colonize human teeth and how this process changes over the lifetime of individuals. It will include an investigation of transmission of bacteria that initiate colonization between adults and from adults to infants.

Selected NIH scientists and members of their immediate families, including infants, are eligible for this study. Participants provide a small sample of saliva and a sample of bacteria collected by rubbing a cotton swab over the surfaces of the lower four incisors. Adults collect and submit their own specimens; a dentist collects specimens from children.


Description:

Interactions between different bacteria play an important role in biofilm development during primary colonization of the human tooth surface. Well studied examples of such interactions include the receptor polysaccharide (RPS)-mediated interactions between viridans group streptococci and other oral bacteria including type 2 fimbriated Actinomyces naeslundii. Previous studies have resulted in the identification of different structural, antigenic and molecular types of RPS on the streptococci that initiate colonization of the tooth surface. This information provides the basis for the current protocol, which addresses a number of important questions involving the nature of the commensal relationship that exists between biofilm-forming bacteria and the host. For example: (1) How many types of RPS are produced by the resident flora of an individual at any one time? (2) Does the resident population of RPS-producing clones change over the lifetime of the host? (3) Do individuals produce secretory antibodies against bacterial RPS, and if so, does this drive a change in the antigenic type of RPS produced? (3) When and how do infants acquire RPS-producing bacteria, before or after tooth eruption? To address these questions, we wish to collect and analyze samples of early dental plaque from the members of individual families. The collection of such samples will be accomplished by gently rubbing exposed tooth surfaces with a sterile cotton swab. Adult volunteers will also be asked to provide small samples of saliva, which will be assayed for the presence of specific anti-RPS antibodies. The sampling procedures proposed in this protocol do not present any significant risk to either adult or infant volunteers. The information gained from these studies, although not directly beneficial to these individuals, is expected to provide important insights into the commensal relationship that exists between biofilm-forming bacteria and the host. This in turn will contribute to an improved understanding of variables associated with the maintenance of oral health and the initiation of disease.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 3, 2009
Est. primary completion date August 3, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Months and older
Eligibility - INCLUSION AND EXCLUSION CRITERIA

This is a pilot study with no inclusion or exclusion criteria other than availability. Participants will include Dr. Yoshida, his wife and their infant son and members of Dr. Cisar's family including his wife and adult children. Other NIH scientists and their infant children will also be included. All participants will be asked to sign the appropriate consent / assent forms.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cisar JO, Sandberg AL, Abeygunawardana C, Reddy GP, Bush CA. Lectin recognition of host-like saccharide motifs in streptococcal cell wall polysaccharides. Glycobiology. 1995 Oct;5(7):655-62. — View Citation

Takahashi Y, Ruhl S, Yoon JW, Sandberg AL, Cisar JO. Adhesion of viridans group streptococci to sialic acid-, galactose- and N-acetylgalactosamine-containing receptors. Oral Microbiol Immunol. 2002 Aug;17(4):257-62. — View Citation

Takahashi Y, Sandberg AL, Ruhl S, Muller J, Cisar JO. A specific cell surface antigen of Streptococcus gordonii is associated with bacterial hemagglutination and adhesion to alpha2-3-linked sialic acid-containing receptors. Infect Immun. 1997 Dec;65(12):5042-51. — View Citation

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1