Aphthous StomatitisNCT00001601
Evaluation and Treatment of Oral Soft Tissue Diseases
A study testing Electrocardiogram, Biopsies and Diagnostic imaging in people with Aphthous Stomatitis and Burning Mouth Syndrome, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphthous Stomatitis, Burning Mouth Syndrome, Lichen Planus
- What is being tested?
- Electrocardiogram, Biopsies and Diagnostic imaging
- Type of treatment
- Surgery or procedure
- How many people
- 999 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1997to Aug 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Aphthous Stomatitis, Burning Mouth Syndrome, Lichen Planus, Mouth Disease, Temporomandibular Joint Disorder
- Being tested
- Electrocardiogram, Biopsies, Diagnostic imaging
- Keywords
- Oral Medicine, Clinical Experience, Therapy, Educational Training, Pathogenesis, Oral Lesions, Aphthous Ulcers, Lichen Planus, Burning Mouth, Temporomandibular Dysfunction (TMD), Oral Disease, Oral Manifestations
- Medical subject headings
- Stomatitis, Aphthous, Burning Mouth Syndrome, Lichen Planus, Mouth Diseases, Temporomandibular Joint Disorders, Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramProcedure or surgery
BiopsiesProcedure or surgery
Diagnostic imagingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1997
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 999 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001601
- Sponsor's protocol ID
- 970169
- Other IDs
- 97-D-0169
- Status last verified
- Aug 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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. doi: 10.1016/s1085-5629(97)80016-8.
PubMed 9421218Axell 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.
PubMed 8667255Ship 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.
PubMed 8665304
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Evaluation and Treatment of Oral Soft Tissue Diseases According to Generally Available, Standard Procedures and Therapeutic Modalities
- ClinicalTrials.gov ID
- NCT00001601
- Acronym / sponsor ID
- 970169
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 999 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Aug 1997
- Study completion
- Aug 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiogram | Procedure or surgery | – |
| Biopsies | Procedure or surgery | – |
| Diagnostic imaging | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9421218Lozada-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.
- Background: PubMed 8667255Axell 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.
- Background: PubMed 8665304Ship 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram, Biopsies and Diagnostic imaging in people with Aphthous Stomatitis and Burning Mouth Syndrome, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001601, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.