Bacterial Arrangement on the Teeth

NCT01712672 | Completed

• 2 other identifiers: 13001413-D-0014
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Plaque; Oral Health; Periodontal Disease and Caries; Periodontal Disease

Keywords

Dental Plaque; Biofilm; Bacterial Interactions; Receptor Polysaccharide; Oral Streptococci; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  within 23 study visits

Study Arms (1)

1

Healthy participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

n/a in data analysis-not recruiting

You may qualify if:

• Healthy adult subjects (as determined from self-reported medical history, evaluation by study dentist and nursing assessment, per policy).
• years of age or older
• Good oral health as determined by screening oral examination with:
• no history of oral cancer
• no active periodontal disease.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 28341674 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Dental Plaque; Periodontal Diseases

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Mouth Diseases

Study Officials

• Niki M Moutsopoulos, D.D.S.

  National Institute of Dental and Craniofacial Research (NIDCR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2012
• First Posted: October 23, 2012
• Study Start: January 16, 2013
• Primary Completion: January 7, 2016
• Study Completion: January 7, 2016
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (1)