Canker SoreNCT00556686
Salivary Catecholamines in Aphthous Stomatitis (Canker Sores)
An observational study of Canker Sore, run by University of California, Davis.
Trial summary
The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Canker Sore
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Dec 2009
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects will be sampled from the community.
Who may be able to join
- Age 18 or older, both genders
- History of recurrent aphthous ulcers with 4 or more episodes per year
Who cannot join
- History of salivary gland disease including Sjogren's disease, parotitis, and sialolithiasis
- History of benign or malignant salivary gland tumor
- History of celiac disease, ulcerative colitis or Crohn's disease
- Patients on medications that affect salivary flow such as anti-depressants and anti-cholinergic medications
About this study
Official title: Salivary Catecholamines in Aphthous Stomatitis
The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing.
Read the detailed description
The purpose of this study is to determine if salivary catecholamines are elevated in patients with the disease aphthous stomatitis. The results of this study will be combined with those performed in collaboration with a co-Investigator to understand the effects of catecholamines on mucosal wound healing and oral epithelial cell migration.
- Conditions
- Canker Sore
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals with a history of canker sores. | |
| 2 | Individuals with no history of canker sores. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: We are currently modifying the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Canker SoreStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Fazel, MD, DDS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556686
- Sponsor's protocol ID
- 200614581
- Status last verified
- Apr 2015
- First submitted
- 8 Nov 2007
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Catecholamines in Aphthous Stomatitis
- ClinicalTrials.gov ID
- NCT00556686
- Acronym / sponsor ID
- 200614581
- Conditions
- Canker Sore
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We are currently modifying the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 12 Nov 2007 (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.
The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing.
Detailed description
The purpose of this study is to determine if salivary catecholamines are elevated in patients with the disease aphthous stomatitis. The results of this study will be combined with those performed in collaboration with a co-Investigator to understand the effects of catecholamines on mucosal wound healing and oral epithelial cell migration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Individuals with a history of canker sores. |
| 2 | – | –Individuals with no history of canker sores. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will be sampled from the community.
Key inclusion criteria (2 listed)
- Age 18 or older, both genders
- History of recurrent aphthous ulcers with 4 or more episodes per year
Key exclusion criteria (4 listed)
- History of salivary gland disease including Sjogren's disease, parotitis, and sialolithiasis
- History of benign or malignant salivary gland tumor
- History of celiac disease, ulcerative colitis or Crohn's disease
- Patients on medications that affect salivary flow such as anti-depressants and anti-cholinergic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
Related trials for Canker Sore
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
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A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
RecruitingPhase 2/3
Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
Aphthus Ulcer
RecruitingPhase 2
Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers
Oral Aphthous Ulcers
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.
Nasim Fazel, MD, DDS principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
An observational study of Canker Sore, run by University of California, Davis.
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 4 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
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 22 Apr 2015.