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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. Identifier: NCT00693550
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : June 8, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Other: metal patch tests

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Relationship between intraoral metal contact allergy and epithelial carcinogenesis [ Time Frame: one year ]
  2. Prevalence of metal contact allergy comparison to study control data [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona


  • Meets 1 of the following criteria:

    • Newly or previously diagnosed oral squamous cell carcinoma

      • Recruited from the otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
    • Healthy volunteer (control)

      • No history of intraoral squamous cell carcinoma
      • Employed at Mayo Clinic Rochester or Mayo Clinic Arizona


  • No immunosuppression
  • No other conditions that interfere with patch testing


  • Not specified

Information from the National Library of Medicine

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 identifier (NCT number): NCT00693550

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Study Chair: James A. Yiannias, MD Mayo Clinic
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Responsible Party: James A. Yiannias M.D., Mayo Clinic Cancer Center Identifier: NCT00693550    
Other Study ID Numbers: 497-00
P30CA015083 ( U.S. NIH Grant/Contract )
CDR0000589036 ( Other Identifier: Mayo Clinic )
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by Mayo Clinic:
lip and oral cavity squamous cell carcinoma
oropharyngeal squamous cell carcinoma
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Dermatitis, Allergic Contact
Neoplasms by Site
Immune System Diseases
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed