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

June 6, 2011 updated by: Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Head and Neck Cancer

Intervention / Treatment

Other: metal patch tests

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.

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relationship between intraoral metal contact allergy and epithelial carcinogenesis Time Frame: one year	one year
Prevalence of metal contact allergy comparison to study control data Time Frame: one year	one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: James A. Yiannias, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria