Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001601
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Evaluation and Treatment of Oral Soft Tissue Diseases
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Patient Evaluation and Treatment of Oral Soft Tissue Diseases According to Generally Available Standard Procedures and Therapeutic Modalities
Status:
COMPLETED
Status Verified Date:
2002-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NIDCRs 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 individuals 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 110- to 15-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 patients condition
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 individuals 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 110- to 15-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 patients 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 andor disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-D-0169 | None | None | None |