Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00693550|
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : June 8, 2011
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Other: metal patch tests|
- 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 Type :||Observational|
|Actual Enrollment :||115 participants|
|Official Title:||Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
- Other: metal patch tests
Twenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days
- Relationship between intraoral metal contact allergy and epithelial carcinogenesis [ Time Frame: one year ]
- Prevalence of metal contact allergy comparison to study control data [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693550
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||James A. Yiannias, MD||Mayo Clinic|