Evaluation and Treatment of Oral Soft Tissue Diseases

March 3, 2008 updated by: National Institute of Dental and Craniofacial Research (NIDCR)

Patient Evaluation and Treatment of Oral Soft Tissue Diseases According to Generally Available, Standard Procedures and Therapeutic Modalities

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, photographs, or other tests as needed for diagnosis

Treatments include tablets, injections and topically applied medications. All preparations are approved by the Food and Drug Administration and are commercially available. Patient follow-up may vary from one visit to intermittent visits over a number of years, depending on the patient's condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The function of this protocol is to support the training of residents in Oral Medicine in the management of oral soft tissue diseases. Patients enrolled in this protocol will be evaluated and treated according to available standard procedures and therapeutic modalities. Samples of blood and oral tissues will be studied by routine and specialized investigative methods to establish the diagnoses, responses to treatment, and/or disease progression.

Study Type

Interventional

Enrollment

999

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Dental and Craniofacial Research (NIDCR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

Patients of any age, both genders, and all racial/ethnic groups with oral diseases or systemic diseases with oral manifestations that will help the branch fulfill the objectives listed in Section 1.0.

Women of childbearing potential, or who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus and/or child. Only diagnosis without radiographs will be performed.

EXCLUSION CRITERIA

A written referral is needed from the patient's physician or dentist.

No patients with significant cognitive impairment.

No pregnancy or lactation, if this status precludes proposed diagnostic procedures or therapies because of unknown, untoward effects on mother and/or child.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

August 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970169
  • 97-D-0169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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