Study of Oral Bacteria in Patients With Dry Mouth

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ClinicalTrials.gov Identifier: NCT00048685

Recruitment Status : Completed

First Posted : November 6, 2002

Last Update Posted : March 4, 2008

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

Study Description

Brief Summary:

This study will examine the types of bacteria present in the dental plaque of patients with persistent dry mouth. Saliva is essential for digestion and swallowing and for maintaining the normal mineralization of teeth. People who suffer from dry mouth usually have a significant increase in tooth decay (caries). This study will determine if this increase is due solely to reduced salivary flow or also to an increase in certain types of bacteria in the mouth.

Patients participating in the following NIDCR protocols may be eligible for this study: Evaluation and Treatment of Salivary Dysfunction (84-D-0056), Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome Research Project (99-D-0070), and Salivary Evaluation in Normal Volunteers (94-D-0018).

Participants will have three appointments at the NIH dental clinic as follows:

Visit 1

Dental examination and instruction on keeping a detailed diary of food intake.

Visit 2 (1 week after visit 1)

Attachment of a bacteria collection device (described below) to the side of a tooth.

Visit 3 (48 hours after visit 2)

Removal of the collection device, tooth cleaning and polishing, and submission of food diary.

The bacteria collection device is a 4mm x 2mm x 2mm square of sterilized tooth obtained from slicing an extracted healthy tooth donated by another patient. The donated teeth are either extracted impacted third molars (wisdom teeth) or teeth extracted for teeth straightening (orthodontics). The device is heat-sterilized before being bonded to the participant's tooth. The dental cement used for bonding can be removed after 48 hours with no damage to the surface of the participant's tooth.

Condition or disease
Xerostomia Autoimmune Diseases

Show Detailed Description

Study Design


Study Type :	Observational
Enrollment :	44 participants
Official Title:	Incidence and Frequency of Cariogenic Microflora in Patients With Clinical Xerostomia and Autoimmune Disease
Study Start Date :	November 2002
Study Completion Date :	August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Autoimmune Diseases Dry Mouth

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Selection of subjects for the study will be restricted to the pool of NIDCR patients already participating in protocol 84-D-0056, Evaluation and Treatment of Salivary Dysfunction.

INCLUSION CRITERIA

A. Salivary Flow = 0.1ml/min pooled unstimulated; and

B. A diagnosis of SS (primary or secondary)

C. A diagnosis of non-SS auto-immune disease

D. The use of a medication with known xerostomic effect

E. Subjective xerostomia or xerophthalmia

F. The presence of permanent teeth.

EXCLUSION CRITERIA

A. Child and Adolescent:

Children and Adolescents will not be included in the study due to the presence of deciduous teeth which are less suitable for bonding and which show an altered enamel morphology and pattern of plaque accumulation

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048685

Locations


United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

More Information

Publications:

Almståhl A, Kroneld U, Tarkowski A, Wikström M. Oral microbial flora in Sjögren's syndrome. J Rheumatol. 1999 Jan;26(1):110-4.

Babaahmady KG, Challacombe SJ, Marsh PD, Newman HN. Ecological study of Streptococcus mutans, Streptococcus sobrinus and Lactobacillus spp. at sub-sites from approximal dental plaque from children. Caries Res. 1998;32(1):51-8.

Boutsi EA, Paikos S, Dafni UG, Moutsopoulos HM, Skopouli FN. Dental and periodontal status of Sjögren's syndrome. J Clin Periodontol. 2000 Apr;27(4):231-5.


ClinicalTrials.gov Identifier:	NCT00048685 History of Changes
Other Study ID Numbers:	030026 03-D-0026
First Posted:	November 6, 2002 Key Record Dates
Last Update Posted:	March 4, 2008
Last Verified:	August 2004

Keywords provided by National Institutes of Health Clinical Center (CC):


Caries Bacteria Saliva Teeth	Autoimmune Dry Mouth Salivary Gland Dysfunction Sjogren's Syndrome

Additional relevant MeSH terms:


Autoimmune Diseases Xerostomia Immune System Diseases	Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases

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