Dental PlaqueNCT01712672
Bacterial Arrangement on the Teeth
An observational study of Dental Plaque and Oral Health, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
Background: Dental plaque is a coating of bacteria on the teeth. It contributes to poor dental health and diseases such as gingivitis, cavities and periodontal disease. Researchers who study plaque know that many different types of oral bacteria stick to each other in test-tube experiments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Plaque, Oral Health, Periodontal Disease and Caries
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2013to 7 Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: n/a in data analysis-not recruiting
Who may be able to join
- Healthy adult subjects (as determined from self-reported medical history, evaluation by study dentist and nursing assessment, per policy).
- 18 years of age or older
- Good oral health as determined by screening oral examination with:
- no history of oral cancer
- no active periodontal disease.
Who cannot join
- History of any medical conditions affecting salivary flow, such as Sj(SqrRoot)(Delta)gren s syndrome
- History of any immunosuppressant therapy, such as glucocorticoids (within the last year), auto-immune or immune diseases such as ulcerative colitis or systemic lupus erythematosis, or current steroid therapy, other than topical, within the last 30 days
- History of cardiac, kidney, liver and lung disorders
- Use of tobacco within the last year
- Use of antibiotics within the preceding four months
- Use of medications thought to affect salivary flow such as head/neck radiation therapy, diuretics, or nitrates. Medications will be checked against product information for effect and reviewed by the protocol dentist.
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- Clinically visible active dental caries.
- Active periodontal disease as defined as no more than 4 sites in the entire mouth with greater than or equal to 5mm probing depths.
- History of severe allergic reactions (Anaphylaxis) to several allergins and specific allergies to or other substances found in the stent or impression material (ie: Plasticized Methacrylate Polymer, methyl methacrylate monomer, alkyl dimethacrylate, benzophenone, Toluidine and Hydroquinone), waxes containing Pine Rosin, and to the list of ingredients for the impression material.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Bacterial Arrangement in Supragingival Biofilms
Background:
- Dental plaque is a coating of bacteria on the teeth. It contributes to poor dental health and diseases such as gingivitis, cavities and periodontal disease. Researchers who study plaque know that many different types of oral bacteria stick to each other in test-tube experiments. However, it is not clear if these interactions occur in natural dental plaque. By studying how bacteria interact, researchers can better understand how bacteria come together and grow to form plaque.
Read more
Objectives:
- To look at how bacteria interact with one another to form dental plaque.
Eligibility:
- Healthy nonsmoking volunteers at least 18 years of age.
Design:
- Participants will be screened with a medical history and dental exam. They will also have dental impressions taken for a stent (a device similar to Invisalign(SqrRoot) braces).
- Participants will wear the stent for up to 8 hours a day on selected study visit days. It will contain enamel chips made from sterilized human teeth. The mouth bacteria will stick to the chips and grow. Chips will be taken out of the stent twice during these study visit days.
- Participants will have other study visits to provide saliva and plaque samples. They will also have gum swabs to collect bacteria.
- Some participants may have a second set of study visits. At these visits, they will chew gum to increase their saliva production. Afterwards, they will wear the stent with the enamel chips for 4 hours. Samples from the stent will be taken once on these study visit days.
Read the detailed description
Dental caries and periodontal disease are closely associated with the oral biofilm known as dental plaque. Much is known about the makeup of this biofilm, especially at its early stage of development (i.e. up to 12 hrs following tooth cleaning). The primary initial colonizers are streptococci, and actinomyces. These bacteria coaggregate frequently with one another by a mechanism that involves binding of protein adhesins on the surface of one cell to complementary cell surface receptor polysaccharides (RPS) on streptococci.
Coaggregation profiles are known for a wide range of oral actinomyces and streptococci. However, despite the potential significance of these interactions in biofilm formation, little is known about their occurrence within oral biofilms in situ.
Objective
The objective of this study is to determine and compare the influence of coaggregation on the spatial organization of bacteria in supragingival dental plaque formed under conditions of normal salivary flow (Arm 1 of the protocol) or increased salivary flow (Arm 2 of the protocol).
Study Population
The study population will consist of up to twenty-five (25) healthy adult subjects 18 years of age and older. All subjects will participate in Arm 1 of the protocol. In addition, at least three volunteers from Arm 1 will participate in Arm 2 of the protocol.
Study Design
This will be an observational, longitudinal protocol to determine the spatial organization of bacteria found within dental plaque of normal healthy subjects. Enrolled subjects will have a standard oral examination (including oral cancer screening) performed in the NIDCR clinic by protocol-listed dental clinicians. A mandibular stent will be custom fabricated based on impressions taken during the exam. Enamel chips cut from previously extracted third molars will be sterilized by ethylene oxide then inserted into the stent on each side over the molar area. We currently have enough extracted third molars in storage to accommodate tooth chips for the entire protocol if four subjects complete the study as projected. If additional chips are needed, the NIDCR is currently in the process of preparing a protocol that will provide extracted teeth, if needed, for this and other protocols. In Arm 1 of the study, a custom-fitted stent will be worn in the mouth of each subject, and chips removed for analysis after 4 or 8 hours of wearing. The bacterial biofilm on the chips will be stained with fluorescent antibodies against specific microbial adhesins or receptors, after which the spatial organization of labeled cells within the biofilm will be documented by laser confocal microscopy. Chips may be used for bacterial isolation and subjects will be asked to provide saliva samples, and site-specific plaque samples (curette scrapings, gum swabs) for molecular taxonomic analysis. Decisions on which subjects will have these samples taken will be based on the reactivity of available antibodies with bacterial communities. Subjects from Arm 1 of the study who are chosen to participate in Arm 2, will chew a gum base for 10 minutes to increase salivary flow while wearing their stent. The stent from these individuals will be removed after 4 hours of additional wear and analyzed as above. Prior to participation in Arm 2 of the protocol, subjects will be advised that the experiments are supported by a CRADA agreement. Through this agreement, only coded research information will be exchanged. The samples will remain with the NIH research team. Individuals may participate in the first arm only, or in both arms of the study, as indicated in their consent document.
Outcome Measures
Outcome measures for this protocol will be the qualitative and quantitative description of the oral bacterial community during development of initial plaque.
- Keywords
- Dental Plaque, Biofilm, Bacterial Interactions, Receptor Polysaccharide, Oral Streptococci, Natural History
- Medical subject headings
- Dental Plaque, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitatively analyze image data to determine the types of bacteria that directly interact with one another on the chip surface to understand community assembly during plaque accumulation
Bacteria will be isolated from chips and plaque samples. Molecular descriptions of total flora (from chips, plaque samples and gum swabs) will provide a list of bacteria present at the sampling time.
Measured: within 23 study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study start16 Jan 2013
- Primary completion7 Jan 2016
- Study completion7 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Niki M Moutsopoulos, D.D.S., Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712672
- Sponsor's protocol ID
- 130014
- Other IDs
- 13-D-0014
- Status last verified
- Jul 2025
- First submitted
- 20 Oct 2012
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet known
Publications
Palmer RJ Jr, Shah N, Valm A, Paster B, Dewhirst F, Inui T, Cisar JO. Interbacterial Adhesion Networks within Early Oral Biofilms of Single Human Hosts. Appl Environ Microbiol. 2017 May 17;83(11):e00407-17. doi: 10.1128/AEM.00407-17. Print 2017 Jun 1.
PubMed 28341674
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Arrangement in Supragingival Biofilms
- ClinicalTrials.gov ID
- NCT01712672
- Acronym / sponsor ID
- 130014
- Keywords
- Dental Plaque, Biofilm, Bacterial Interactions, Receptor Polysaccharide, Oral Streptococci, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 16 Jan 2013 (actual)
- Primary completion
- 7 Jan 2016 (actual)
- Study completion
- 7 Jan 2016 (actual)
- First posted
- 23 Oct 2012 (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.
Background:
- Dental plaque is a coating of bacteria on the teeth. It contributes to poor dental health and diseases such as gingivitis, cavities and periodontal disease. Researchers who study plaque know that many different types of oral bacteria stick to each other in test-tube experiments. However, it is not clear if these interactions occur in natural dental plaque. By studying how bacteria interact, researchers can better understand how bacteria come together and grow to form plaque.
Objectives:
- To look at how bacteria interact with one another to form dental plaque.
Eligibility:
- Healthy nonsmoking volunteers at least 18 years of age.
Design:
- Participants will be screened with a medical history and dental exam. They will also have dental impressions taken for a stent (a device similar to Invisalign(SqrRoot) braces).
- Participants will wear the stent for up to 8 hours a day on selected study visit days. It will contain enamel chips made from sterilized human teeth. The mouth bacteria will stick to the chips and grow. Chips will be taken out of the stent twice during these study visit days.
- Participants will have other study visits to provide saliva and plaque samples. They will also have gum swabs to collect bacteria.
- Some participants may have a second set of study visits. At these visits, they will chew gum to increase their saliva production. Afterwards, they will wear the stent with the enamel chips for 4 hours. Samples from the stent will be taken once on these study visit days.
Detailed description
Dental caries and periodontal disease are closely associated with the oral biofilm known as dental plaque. Much is known about the makeup of this biofilm, especially at its early stage of development (i.e. up to 12 hrs following tooth cleaning). The primary initial colonizers are streptococci, and actinomyces. These bacteria coaggregate frequently with one another by a mechanism that involves binding of protein adhesins on the surface of one cell to complementary cell surface receptor polysaccharides (RPS) on streptococci.
Coaggregation profiles are known for a wide range of oral actinomyces and streptococci. However, despite the potential significance of these interactions in biofilm formation, little is known about their occurrence within oral biofilms in situ.
Objective
The objective of this study is to determine and compare the influence of coaggregation on the spatial organization of bacteria in supragingival dental plaque formed under conditions of normal salivary flow (Arm 1 of the protocol) or increased salivary flow (Arm 2 of the protocol).
Study Population
The study population will consist of up to twenty-five (25) healthy adult subjects 18 years of age and older. All subjects will participate in Arm 1 of the protocol. In addition, at least three volunteers from Arm 1 will participate in Arm 2 of the protocol.
Study Design
This will be an observational, longitudinal protocol to determine the spatial organization of bacteria found within dental plaque of normal healthy subjects. Enrolled subjects will have a standard oral examination (including oral cancer screening) performed in the NIDCR clinic by protocol-listed dental clinicians. A mandibular stent will be custom fabricated based on impressions taken during the exam. Enamel chips cut from previously extracted third molars will be sterilized by ethylene oxide then inserted into the stent on each side over the molar area. We currently have enough extracted third molars in storage to accommodate tooth chips for the entire protocol if four subjects complete the study as projected. If additional chips are needed, the NIDCR is currently in the process of preparing a protocol that will provide extracted teeth, if needed, for this and other protocols. In Arm 1 of the study, a custom-fitted stent will be worn in the mouth of each subject, and chips removed for analysis after 4 or 8 hours of wearing. The bacterial biofilm on the chips will be stained with fluorescent antibodies against specific microbial adhesins or receptors, after which the spatial organization of labeled cells within the biofilm will be documented by laser confocal microscopy. Chips may be used for bacterial isolation and subjects will be asked to provide saliva samples, and site-specific plaque samples (curette scrapings, gum swabs) for molecular taxonomic analysis. Decisions on which subjects will have these samples taken will be based on the reactivity of available antibodies with bacterial communities. Subjects from Arm 1 of the study who are chosen to participate in Arm 2, will chew a gum base for 10 minutes to increase salivary flow while wearing their stent. The stent from these individuals will be removed after 4 hours of additional wear and analyzed as above. Prior to participation in Arm 2 of the protocol, subjects will be advised that the experiments are supported by a CRADA agreement. Through this agreement, only coded research information will be exchanged. The samples will remain with the NIH research team. Individuals may participate in the first arm only, or in both arms of the study, as indicated in their consent document.
Outcome Measures
Outcome measures for this protocol will be the qualitative and quantitative description of the oral bacterial community during development of initial plaque.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- n/a in data analysis-not recruiting
Key inclusion criteria (5 listed)
- Healthy adult subjects (as determined from self-reported medical history, evaluation by study dentist and nursing assessment, per policy).
- 18 years of age or older
- Good oral health as determined by screening oral examination with:
Key exclusion criteria (9 listed)
- History of any medical conditions affecting salivary flow, such as Sj(SqrRoot)(Delta)gren s syndrome
- History of any immunosuppressant therapy, such as glucocorticoids (within the last year), auto-immune or immune diseases such as ulcerative colitis or systemic lupus erythematosis, or current steroid therapy, other than topical, within the last 30 days
- History of cardiac, kidney, liver and lung disorders
- Use of tobacco within the last year
- Use of antibiotics within the preceding four months
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
qualitatively analyze image data to determine the types of bacteria that directly interact with one another on the chip surface to understand community assembly during plaque accumulation
Time frame: within 23 study visits
Bacteria will be isolated from chips and plaque samples. Molecular descriptions of total flora (from chips, plaque samples and gum swabs) will provide a list of bacteria present at the sampling time.
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 30 Jul 2025.
- Background: PubMed 28341674Palmer RJ Jr, Shah N, Valm A, Paster B, Dewhirst F, Inui T, Cisar JO. Interbacterial Adhesion Networks within Early Oral Biofilms of Single Human Hosts. Appl Environ Microbiol. 2017 May 17;83(11):e00407-17. doi: 10.1128/AEM.00407-17. Print 2017 Jun 1.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. not yet known
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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.
Niki M Moutsopoulos, D.D.S. principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
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 Dental Plaque and Oral Health, 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 5 inclusion and 9 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 30 Jul 2025. 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.
What does the primary outcome measure?
qualitatively analyze image data to determine the types of bacteria that directly interact with one another on the chip surface to understand community assembly during plaque accumulation (time frame: within 23 study visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712672, which also lists 1 linked publication.
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 30 Jul 2025.