To evaluate the agreement between the results of four diagnostic tests for metal allergy (in vivo patch tests, resp. Lymfocyte Proliferation Test (LPT), a modified LPT (MELISA®), and the Lymfocyte Cytokine Production Test (LCPT), and the clinical…
ID
Source
Brief title
Condition
- Other condition
- Allergic conditions
- Epidermal and dermal conditions
Synonym
Health condition
tandheelkundige slijmvlies aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determination of correlation coefficients between test results of four selected
tests mutually as well as in relation with the diagnostic image of metal
allergiy linked to an oral exposure to dental alloys.
Secondary outcome
not applicable
Background summary
Beside the contemporary in vivo epicutaneous patch test, recently also in vitro
tests are described for the diagnosis of type IV metal allergies. Such
allergies are usually the result of a skin contact, but may also be caused or
aggrevated by oral exposure to metal alloys. In spite of the fact that patch
testing is the only diagnostic system currently available for routine
diagnostics in the Netherlands its value for the diagnostics of a type IV
allergy, originating from an oral exposure to metals, is still unclear.
Meanwhile there is discussion over the diagnostic value of the recently
developed in vitro tests. This study has as aim to determine agreement between
the results of in vivo patch tests, some specially selected in vitro tests and
the diagnostic allergic symptoms that are linked with oral metal exposure
obtained from examination and an anamnesis.
Three in vitro tests are selected, the Lymfocyte Proliferation Test (LPT), a
modification of LPT (MELISA®) and a Lymfocyte Cytokine Production Test (LCPT).
Study objective
To evaluate the agreement between the results of four diagnostic tests for
metal allergy (in vivo patch tests, resp. Lymfocyte Proliferation Test (LPT), a
modified LPT (MELISA®), and the Lymfocyte Cytokine Production Test (LCPT), and
the clinical diagnose with regard to a possible metal allergy linked to oral
exposure.
Study design
Observational study
Study burden and risks
Participants of this study will be exposed to different amounts of burden. For
the estimation of burden one has to differentiate between regular and
experimental diagnostics. In that view the volunteers will have a larger burden
than the patients involved in this study.
Diagnostic protocol of ACTA Department of Oral Diagnostics.
1. Anamnesis.
2. Intra-oral examination, comparable to a dental half year check-up.
3. Metal biopsy of metal based restorations to reveal the oral metal exposure
of the patients/participant.
4. Panorama X-ray photograph, effective dose 6-11 *Sv (RIVM).
5. Communication of findings with the patient
6. Reporting to referral dentist/physician
Total time needed for this part is approximately 90 min.
Diagnostic protocol VUmc Department of Dermato-Allergology
1. Anamnesis.
2. Body examination
3. Epicutane patch testing
4. reading of test results after 48, 72 and 144 hours.
5. Communication of findings with the patient
6. Reporting to referral dentist/physician
Total time needed for this part is approximately 90 min.
Venapunction to collect 130 ml blood for the in vitro tests.
Adverse and serious adverse events
Only the venapunction and the patch testing may produce some mild adverse
events.
Louwesweg 1
1066 EA Amsterdam
Nederland
Louwesweg 1
1066 EA Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients (>18 year) where the anamnesis gives rise to a suspicion of a metal allergy based on an oral exposure and where intra-oral inspection showed one of the following symptoms:
1) not plaque related mucosa deviation (e.g. gingivitis, periodontitis),
2) Lichenoid reaction,
3) Lingua geographica,
4) Local erosion,
5) Edema,
6) Erythema.
Exclusion criteria
Patients/volunteers where the anamnesis showed malignancies and/or systemic diseases, or other disorders that hinder the execution of in vivo or in vitro allergy testing. ;Patients/volunteers who are pregnant.;The use of drugs that interferes with in vivo and/or in vitro allergic diagnostic tests.;Patients not willing to undergo the general diagnostic examination as normally offered by the department of Dermato-Allergy (VUmc) or the department of Oral Diagnostics (ACTA).;Patients of the negative control group were not positive patch tested before and should not have a history of eczema.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15650.029.06 |