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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00693550
First received: June 6, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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 Intervention
Head and Neck Cancer
Other: metal patch tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Relationship between intraoral metal contact allergy and epithelial carcinogenesis [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Prevalence of metal contact allergy comparison to study control data [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: August 2000
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693550

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: James A. Yiannias, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: James A. Yiannias M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00693550     History of Changes
Other Study ID Numbers: 497-00, P30CA015083, CDR0000589036
Study First Received: June 6, 2008
Last Updated: June 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
lip and oral cavity squamous cell carcinoma
oropharyngeal squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on April 17, 2014