deltatrials
Terminated OBSERVATIONAL NCT00001196

Evaluation of Salivary Gland Dysfunction

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Updated 9 times since 2017 Last updated: Jun 30, 2017 Started: Mar 23, 1984 Completion: Sep 29, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

Listed as NCT00001196, this observational or N/A phase trial focuses on Salivary Gland and Sjogren's Syndrome and remains terminated or withdrawn. Sponsored by National Institute of Dental and Craniofacial Research (NIDCR), it has been updated 9 times since 1984, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

This study will evaluate participants with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary secretions have antibacterial, lubricating, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning or ulcerated or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell. Participants with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study. Participants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the tongue. Several blood samples will also be drawn for tests. Some participants will have a biopsy of the minor salivary glands, usually from inside the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and to determine the extent of changes in the salivary glands. An eye examination including a standard eye examination and a dry eye assessment is done. The ability to taste and smell may also be evaluated, and participants may...

This study will evaluate participants with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary secretions have antibacterial, lubricating, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning or ulcerated or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell.

Participants with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study.

Participants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the tongue. Several blood samples will also be drawn for tests. Some participants will have a biopsy of the minor salivary glands, usually from inside the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and to determine the extent of changes in the salivary glands. An eye examination including a standard eye examination and a dry eye assessment is done. The ability to taste and smell may also be evaluated, and participants may have an ultrasound examination of their swallowing function.

Status Flow

~Jan 2017 – ~May 2017 · 4 months · monthly snapshotTerminated~May 2017 – ~Jun 2017 · 31 days · monthly snapshotTerminated~Jun 2017 – ~Apr 2018 · 10 months · monthly snapshotTerminated~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated

  2. Sep 2024 — Present [monthly]

    Terminated

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated

Show 4 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Terminated

    Phase: NANone

  2. Jun 2017 — Apr 2018 [monthly]

    Terminated NA

  3. May 2017 — Jun 2017 [monthly]

    Terminated NA

  4. Jan 2017 — May 2017 [monthly]

    Terminated NA

    First recorded

Mar 1984

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Dental and Craniofacial Research (NIDCR)
Data source: National Institutes of Health Clinical Center (CC)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations