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
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, see Learn About Clinical Studies.

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 July 24, 2014