Study of Oral Bacteria in Patients With Dry Mouth

Completed

Conditions studied: Xerostomia, Autoimmune Diseases

In brief

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.

Key facts

Study ID

NCT00048685

Run by

National Institute of Dental and Craniofacial Research (NIDCR)

People needed

44

Starts

2002-11-01

Expected to finish

2004-08-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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