Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer
|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 ]
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|