Study of the Composition of Dental Plaque
Spatial Organization of Viridans Streptococci in Oral Biofilms
2 other identifiers
observational
50
1 country
1
Brief Summary
This study will examine the composition of dental plaque-a naturally occurring substance that sticks to the teeth and can cause tooth decay and gum disease. A better understanding of how plaque builds up in the mouth may help in developing improved ways of controlling it. Healthy normal volunteers between the ages of 18 and 65 who work at the National Institutes of Health main campus in Bethesda, Maryland, may participate in this study. Candidates will be screened for eligibility with a medical and dental history. This study involves a maximum of five visits to the dental clinic. At the first visit, participants will have a dental examination, and a mold will be made of the mouth. To make the mold, a small plastic tray containing impression material will be placed in the volunteer's mouth and held in place for about 2 minutes to set. The tray will then be removed and a mold will be made from the impression. The mold will be used to make the mouthpiece used in study 1, described below, and the tooth fittings used in study 2, also described below. Volunteers will participate in one of these two studies. Study 1. Volunteers in study 1 will have their mouthpiece checked at the second visit, have a teeth cleaning, and have the mold put in place. The mouthpiece will be worn for up to 8 hours, during which time soft foods can be eaten. Mouthwash should not be used while the device is in place. At the volunteer's third (last) visit, the mouthpiece will be removed and the volunteer will spit into a tube to collect saliva for examination for bacteria. Study 2. Volunteers in study 2 will have their teeth cleaned at the second visit and the tooth fittings placed onto the back teeth with a dental adhesive. The fittings will be worn for up to 72 hours, during which time volunteers can eat a regular diet and brush their teeth. Mouthwash should not be used while the fittings are in place. At the third, fourth and fifth visits, some of the fittings will be removed and, if necessary, the tooth surface will be polished. The last of the fittings will be removed at the fifth visit and the volunteer will spit into a tube to collect saliva for examination for bacteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 1998
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 1998
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2009
CompletedJuly 2, 2017
August 3, 2009
11.1 years
November 3, 1999
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Aged 18 to 65 years
You may not qualify if:
- History of medical conditions affecting salivary flow.
- History of immunosuppressant therapy.
- Use of tobacco.
- Use of antibiotics within the preceding four months.
- Use of medications thought to affect salivary flow.
- Missing any maxillary premolar, first, or second molar.
- Unwilling or unable to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Bos R, van der Mei HC, Busscher HJ. Co-adhesion of oral microbial pairs under flow in the presence of saliva and lactose. J Dent Res. 1996 Feb;75(2):809-15. doi: 10.1177/00220345960750021201.
PMID: 8655779BACKGROUNDCisar JO, Sandberg AL, Reddy GP, Abeygunawardana C, Bush CA. Structural and antigenic types of cell wall polysaccharides from viridans group streptococci with receptors for oral actinomyces and streptococcal lectins. Infect Immun. 1997 Dec;65(12):5035-41. doi: 10.1128/iai.65.12.5035-5041.1997.
PMID: 9393793BACKGROUNDFrandsen EV, Pedrazzoli V, Kilian M. Ecology of viridans streptococci in the oral cavity and pharynx. Oral Microbiol Immunol. 1991 Jun;6(3):129-33. doi: 10.1111/j.1399-302x.1991.tb00466.x.
PMID: 1945494BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
June 19, 1998
Primary Completion
August 3, 2009
Study Completion
August 3, 2009
Last Updated
July 2, 2017
Record last verified: 2009-08-03