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OpenTrials
Completed

NCT Number: NCT00693550

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Lymphoid Interstitial Pneumonia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metal patch tests

Other

Twenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Jun 9, 2008
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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