Dental Caries Clinical Trial
Official title:
Spatial Organization of Viridans Streptococci in Oral Biofilms
Verified date | August 3, 2009 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 3, 2009 |
Est. primary completion date | August 3, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
- INCLUSION CRITERIA: Aged 18 to 65 years EXCLUSION CRITERIA: 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
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. — View Citation
Cisar 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. — View Citation
Frandsen EV, Pedrazzoli V, Kilian M. Ecology of viridans streptococci in the oral cavity and pharynx. Oral Microbiol Immunol. 1991 Jun;6(3):129-33. — View Citation
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