Identification of inflammatory mediator profiles associated with dental devices in order to provide leads in detecting an oral allergic reaction.

• Conditions: 10040790; Allergy; Type IV hypersensitivity; 10001708

• Registration Number: NL-OMON45591
• Lead Sponsor: Academisch Centrum Tandheelkunde Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Patients suspected of having an allergic reaction to palladium or nickel in their dental restorative material and who are orally exposed to these metals by their dental devices and who are scheduled to receive a routine skin patch test at the outpatient clinic Dermato-allergology & occupational dermatology at the VU University Medical Centre for diagnosis of nickel and palladium allergy.
* Patients must be willing to undergo crevicular fluid collection, venipuncture and skin adhesive tape stripping

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Pregnancy or lactation
* Age under 18 or above 80
* Smoking, no more than ten cigarettes per day
* Legally incompetent adults
* Usage of systemic immunosuppressive drugs (e.g. prednison, acitretine, adalimumab, efalizumab, etanercept, methoxsaleen, cyclosporine, azathioprine, infliximab and methothrexate) and antibiotics at least 2 weeks prior to starting of the study NB: Medication that reasonably not intervenes with the study procedures (e.g. an antihistaminicum can be used during the study)
* Severe disorders within the last 6 month, e.g. cancer, acute cardiac- and circularity disorders, serious diabetics
* Participation in a study with pharmaceutical within a period of at least 4 weeks prior to this study
* Immunological disorders, e.g. HIV, infectious hepatitis,
* Alcohol and drug abuse
* Eating or drinking (except water) in the morning preceding the first appointment
* Brushing of the teeth ( toothpaste) the morning preceding the first appointment

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Determine differences in cytokine profiles obtained from gingiva crevicular<br /><br>fluid samples derived from both test groups.<br /><br>* Determine correlation of lymphocyte proliferation test/cytokine secretion<br /><br>test upon in vitro stimulation with metal salts (Ni, Pd) with suspected metal<br /><br>allergy.<br /><br>* Determine correlation of skin tape strip secretome with suspected metal<br /><br>allergy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>