Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45591
Enrollment
50
Registered
2018-06-13
Start date
2017-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Allergy Type IV hypersensitivity

Interventions

Contact dermatitis
Crevicular fluid
Cytokine profile
Dental reconstructive material
Gingiva
Mesoscale
Nickel allergy
Palladiuim allergy
Skin

Sponsors

Academisch Centrum Tandheelkunde Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)