HealthyNCT00098267
Collection of Dental Plaque and Saliva for Studies of Bacterial Colonization of Teeth
An observational study of Healthy, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2004to 3 Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Collection of Dental Plaque and Saliva for Studies of Oral Microbial Colonization
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.
Read the detailed 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.
- Conditions
- Healthy
- Keywords
- Bacteria, Biofilm Formation, Secretory Antibodies, Teeth, Health and Disease
- Medical subject headings
- Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2004 (estimated)
- Study start2 Dec 2004
- Primary completion3 Aug 2009
- Study completion3 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098267
- Sponsor's protocol ID
- 050051
- Other IDs
- 05-D-0051
- Status last verified
- 3 Aug 2009
- First submitted
- 12 Jul 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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. doi: 10.1093/glycob/5.7.655.
PubMed 8608267Takahashi 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. doi: 10.1128/iai.65.12.5042-5051.1997.
PubMed 9393794Takahashi 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. doi: 10.1034/j.1399-302x.2002.170409.x.
PubMed 12121477
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Dental Plaque and Saliva for Studies of Oral Microbial Colonization
- ClinicalTrials.gov ID
- NCT00098267
- Acronym / sponsor ID
- 050051
- Conditions
- Healthy
- Keywords
- Bacteria, Biofilm Formation, Secretory Antibodies, Teeth, Health and Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 2 Dec 2004
- Primary completion
- 3 Aug 2009 (actual)
- Study completion
- 3 Aug 2009 (actual)
- First posted
- 6 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8608267Cisar 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. doi: 10.1093/glycob/5.7.655.
- Background: PubMed 9393794Takahashi 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. doi: 10.1128/iai.65.12.5042-5051.1997.
- Background: PubMed 12121477Takahashi 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. doi: 10.1034/j.1399-302x.2002.170409.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00098267, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.