Study of Oral Bacteria in Patients With Dry Mouth
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00048685 |
Recruitment Status :
Completed
First Posted : November 6, 2002
Last Update Posted : March 4, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Maryland | |
National Institute of Dental And Craniofacial Research (NIDCR) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00048685 |
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 |
Caries Bacteria Saliva Teeth |
Autoimmune Dry Mouth Salivary Gland Dysfunction Sjogren's Syndrome |
Xerostomia Autoimmune Diseases Immune System Diseases |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |