Bacterial Arrangement on the Teeth

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier:
NCT01712672
First received: October 20, 2012
Last updated: July 1, 2014
Last verified: June 2014
  Purpose

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.

Condition
Dental Plaque
Oral Health
Periodontal Disease and Caries
Periodontal Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Bacterial Arrangement in Supragingival Biofilms

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Arrangement of Oral Microflora on Tooth Surfaces

Secondary Outcome Measures:
  • Effect of Chewing Gum on Arrangement and Type of Oral Microflora
  • Molecular Analysis of Oral Microflora Composition

Estimated Enrollment: 25
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • 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.

EXCLUSION CRITERIA:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712672

Contacts
Contact: Linda A McCullagh, R.N. (301) 943-4315 mccullaghl@mail.nih.gov
Contact: John O Cisar, Ph.D. (301) 496-1822 jcisar@dir.nidcr.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: John O Cisar, Ph.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier: NCT01712672     History of Changes
Other Study ID Numbers: 130014, 13-D-0014
Study First Received: October 20, 2012
Last Updated: July 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Dental Plaque
Biofilm
Bacterial Interactions
Receptor Polysaccharide
Oral Streptococci

Additional relevant MeSH terms:
Dental Plaque
Periodontal Diseases
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on July 24, 2014