NCT00001726

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2009

Completed
Last Updated

July 2, 2017

Status Verified

August 3, 2009

Enrollment Period

11.1 years

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

Bacterial ColonizationPlaqueMouthSalivaAdhesionDental Plaque FormationDental Caries

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 8655779BACKGROUND
  • 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. doi: 10.1128/iai.65.12.5035-5041.1997.

    PMID: 9393793BACKGROUND
  • 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. doi: 10.1111/j.1399-302x.1991.tb00466.x.

    PMID: 1945494BACKGROUND

MeSH Terms

Conditions

Dental CariesDental PlaquePeriodontal DiseasesPlaque, AmyloidTissue Adhesions

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental DepositsMouth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCicatrixFibrosisPathologic Processes

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

Locations