NCT00048685

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2002

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

November 1, 2002

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2004

First QC Date

November 5, 2002

Last Update Submit

March 3, 2008

Conditions

XerostomiaAutoimmune Diseases

Keywords

CariesBacteriaSalivaTeethAutoimmuneDry MouthSalivary Gland DysfunctionSjogren's Syndrome

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Almstahl A, Kroneld U, Tarkowski A, Wikstrom M. Oral microbial flora in Sjogren's syndrome. J Rheumatol. 1999 Jan;26(1):110-4.

    PMID: 9918250BACKGROUND

  • 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. doi: 10.1159/000016430.

    PMID: 9438572BACKGROUND

  • Boutsi EA, Paikos S, Dafni UG, Moutsopoulos HM, Skopouli FN. Dental and periodontal status of Sjogren's syndrome. J Clin Periodontol. 2000 Apr;27(4):231-5. doi: 10.1034/j.1600-051x.2000.027004231.x.

    PMID: 10783835BACKGROUND

MeSH Terms

Conditions

XerostomiaAutoimmune DiseasesSjogren's Syndrome

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesImmune System DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 5, 2002

First Posted

November 6, 2002

Study Start

November 1, 2002

Study Completion

August 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-08

Locations

US(1)