Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 4:04 PM
Study NCT ID:
NCT00693550
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?
Status:
COMPLETED
Status Verified Date:
2011-06
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:
RATIONALE: Gathering information about allergies to metals may help doctors learn whether having an allergy to metal used in dental work increases the risk of developing oral cancer.
PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.
PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.
Detailed Description:
OBJECTIVES:
* Identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma.
* Compare the prevalence of metal contact allergy in these patients with control data from other existing study populations.
OUTLINE: This is a multicenter study.
* Participants undergo metal patch testing using 27 metals\* commonly used in dental repairs that are part of the Mayo metal series. Metal patches are applied to the patient's back for 3 days and the back is read on days 3 and 5. Relevant patient data obtained from their medical and dental history, physical exam, laboratory values and treatment are documented.
NOTE: \*Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens.
* Identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma.
* Compare the prevalence of metal contact allergy in these patients with control data from other existing study populations.
OUTLINE: This is a multicenter study.
* Participants undergo metal patch testing using 27 metals\* commonly used in dental repairs that are part of the Mayo metal series. Metal patches are applied to the patient's back for 3 days and the back is read on days 3 and 5. Relevant patient data obtained from their medical and dental history, physical exam, laboratory values and treatment are documented.
NOTE: \*Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000589036 | OTHER | Mayo Clinic | View |