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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00693550

Enrollment

115

Registered

2008-06-09

Start date

2000-08-31

Completion date

2009-01-31

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

lip and oral cavity squamous cell carcinoma, oropharyngeal squamous cell carcinoma

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.

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.

Interventions

OTHERmetal patch tests

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026