Evaluation and Treatment of Oral Soft Tissue Diseases

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Evaluation and Treatment of Oral Soft Tissue Diseases

First Received: November 3, 1999
Last Updated: March 3, 2008 History of Changes
Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001601

Purpose

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.

Condition
Aphthous Stomatitis
Burning Mouth Syndrome
Lichen Planus
Mouth Disease
Temporomandibular Joint Disorder

Intervention
Procedure: Electrocardiogram
Procedure: Biopsies
Procedure: Diagnostic imaging

Study Type: Interventional
Official Title: Patient Evaluation and Treatment of Oral Soft Tissue Diseases According to Generally Available, Standard Procedures and Therapeutic Modalities

urther study details as provided by National Institutes of Health Clinical Center (CC):



Estimated Enrollment: 999
Study Start Date: August 1997
Estimated Study Completion Date: August 2002
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.

Eligibility

Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001601

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
More Information

Publications:
Lozada-Nur F, Miranda C. Oral lichen planus: epidemiology, clinical characteristics, and associated diseases. Semin Cutan Med Surg. 1997 Dec;16(4):273-7. Review.
Axell T, Pindborg JJ, Smith CJ, van der Waal I. Oral white lesions with special reference to precancerous and tobacco- related lesions: conclusions of an international symposium held in Uppsala, Sweden, May 18-21 1994. International Collaborative Group on Oral White Lesions. J Oral Pathol Med. 1996 Feb;25(2):49-54. Review.
Ship JA. Recurrent aphthous stomatitis. An update. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Feb;81(2):141-7. Review.

Study ID Numbers: 970169, 97-D-0169
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001601 History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Oral Medicine
Oral Lesions
Burning Mouth
Oral Disease
Oral Manifestations
Clinical Experience
Therapy
Educational Training
Pathogenesis
Aphthous Ulcers
Lichen Planus
Temporomandibular Dysfunction (TMD)

Study placed in the following topic categories:
Mouth Diseases
Lichen Planus
Skin Diseases
Stomatitis
Myofascial Pain Syndromes
Fibromyalgia
Joint Diseases
Ulcer
Pain
Stomatitis, Aphthous
Exanthema
Aphthous Stomatitis
Temporomandibular Joint Disorders
Muscular Diseases
Temporomandibular Joint Dysfunction Syndrome
Oral Manifestations
Musculoskeletal Diseases
Craniomandibular Disorders
Stomatognathic Diseases
Skin Diseases, Papulosquamous
Burning Mouth Syndrome

Additional relevant MeSH terms:
Temporomandibular Joint Dysfunction Syndrome
Burning Mouth Syndrome
Mouth Diseases
Myofascial Pain Syndromes
Syndrome
Lichen Planus
Mandibular Diseases
Disease
Skin Diseases
Stomatitis
Joint Diseases
Jaw Diseases
Stomatitis, Aphthous
Temporomandibular Joint Disorders
Muscular Diseases
Pathologic Processes
Musculoskeletal Diseases
Craniomandibular Disorders
Stomatognathic Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 07, 2009