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.
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.
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.
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.