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Evaluation and Treatment of Oral Soft Tissue Diseases

Primary Purpose

Aphthous Stomatitis, Burning Mouth Syndrome, Lichen Planus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrocardiogram
Biopsies
Diagnostic imaging
Sponsored by
National Institute of Dental and Craniofacial Research (NIDCR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Aphthous Stomatitis focused on measuring Oral Medicine, Clinical Experience, Therapy, Educational Training, Pathogenesis, Oral Lesions, Aphthous Ulcers, Lichen Planus, Burning Mouth, Temporomandibular Dysfunction (TMD), Oral Disease, Oral Manifestations

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Dental And Craniofacial Research (NIDCR)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00001601
Brief Title
Evaluation and Treatment of Oral Soft Tissue Diseases
Official Title
Patient Evaluation and Treatment of Oral Soft Tissue Diseases According to Generally Available, Standard Procedures and Therapeutic Modalities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

5. Study Description

Brief 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, 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Stomatitis, Burning Mouth Syndrome, Lichen Planus, Mouth Disease, Temporomandibular Joint Disorder
Keywords
Oral Medicine, Clinical Experience, Therapy, Educational Training, Pathogenesis, Oral Lesions, Aphthous Ulcers, Lichen Planus, Burning Mouth, Temporomandibular Dysfunction (TMD), Oral Disease, Oral Manifestations

7. Study Design

Study Phase
Not Applicable
Enrollment
999 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Electrocardiogram
Intervention Type
Procedure
Intervention Name(s)
Biopsies
Intervention Type
Procedure
Intervention Name(s)
Diagnostic imaging

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Dental And Craniofacial Research (NIDCR)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9421218
Citation
Lozada-Nur F, Miranda C. Oral lichen planus: epidemiology, clinical characteristics, and associated diseases. Semin Cutan Med Surg. 1997 Dec;16(4):273-7. doi: 10.1016/s1085-5629(97)80016-8.
Results Reference
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PubMed Identifier
8667255
Citation
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. doi: 10.1111/j.1600-0714.1996.tb00191.x.
Results Reference
background
PubMed Identifier
8665304
Citation
Ship JA. Recurrent aphthous stomatitis. An update. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Feb;81(2):141-7. doi: 10.1016/s1079-2104(96)80403-3.
Results Reference
background

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Evaluation and Treatment of Oral Soft Tissue Diseases

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