Study of Oral Bacteria in Patients With Dry Mouth

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00048685
First received: November 5, 2002
Last updated: March 3, 2008
Last verified: August 2004
  Purpose

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
Xerostomia
Autoimmune Diseases

Study Type: Observational
Official Title: Incidence and Frequency of Cariogenic Microflora in Patients With Clinical Xerostomia and Autoimmune Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 44
Study Start Date: November 2002
Estimated Study Completion Date: August 2004
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048685

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00048685     History of Changes
Other Study ID Numbers: 030026, 03-D-0026
Study First Received: November 5, 2002
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014