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NCT00001601 · ClinicalTrials.gov registry record · NA

Evaluation and Treatment of Oral Soft Tissue Diseases

A NA study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

Completed
Registry status
NA
Development phase
999
Enrollment target

NCT00001601: Completed NA study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

NCT00001601 is a NA study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 999 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001601, a NA study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

COMPLETED
Registry status
NA
Development phase
999 participants
Enrollment target

Study Summary

This study offers evaluation and treatment of patients with diseases of the mouth or systemic diseases that involve the mouth. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purposes of the study are: 1) to allow NIDCR's Gene Therapy and Therapeutics Branch staff to gain more knowledge about oral soft tissue diseases and possibly identify new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.) Patients of any age with oral diseases or systemic diseases involving the mouth may be eligible for this study. Women of childbearing potential and women who are pregnant or breastfeeding will only have tests and procedures and receive medications that pose no greater than a minimal risk to the fetus. Participants will have a comprehensive dental and medical examination, including a physical examination of the head and neck. Additional tests and procedures that may be required for diagnosis and to guide treatment include the following: * Blood and urine tests - for routine laboratory studies, assessment of kidney and liver function, and detection of viruses, fungi, bacteria or parasites * Electrocardiogram - to record the electrical activity of the heart * Biopsies - to examine tissue under the microscope. The method and number of biopsies depends on the individual's specific condition and the tissue to be removed. For all biopsies a local anesthetic (lidocaine with or without epinephrine) is injected at the biopsy site. A punch biopsy uses a small sharp cookie-cutter instrument to remove a small (about 1/10- to 1/5-inch) piece of skin. An excisional biopsy uses a small surgical knife or scalpel to remove a piece of tissue, usually requiring some stitches to close the wound. * Diagnostic imaging - X-rays, photograph

Interventions

  • PROCEDURE Electrocardiogram
  • PROCEDURE Biopsies
  • PROCEDURE Diagnostic imaging

Trial Details

FieldValue
Enrollment Target 999 participants
Start Date 1997-08
Est. Completion 2002-08
Phase NA

What the finished NCT00001601 record still lists

NCT00001601 is an interventional study that assigns participants to a tested intervention. The registered 999 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 3 interventions - of which Electrocardiogram is the first listed.

NCT00001601 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001601 about?

NCT00001601 is a clinical study titled "Evaluation and Treatment of Oral Soft Tissue Diseases". This study offers evaluation and treatment of patients with diseases of the mouth or systemic diseases that involve the mouth. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purposes of the study are: 1) to allow NIDCR's Ge...

What is the current status of trial NCT00001601?

This trial is currently completed. It is a NA study. The enrollment target is 999 participants. The study started on 1997-08. Estimated completion is 2002-08.

What interventions are being tested in trial NCT00001601?

The interventions under investigation include: Electrocardiogram (PROCEDURE), Biopsies (PROCEDURE), Diagnostic imaging (PROCEDURE).

Who is sponsoring clinical trial NCT00001601?

This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001601's enrollment target sits among peer trials

999 121st of 2000 higher than 1,880 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001601, the US trial registry maintained by the National Library of Medicine. NCT00001601 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.