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Pilot study on the influence of corrosion-induced release of metal ions by fixed orthodontic appliances (MBA) on the human immune system and salivary composition

Pilot study on the influence of corrosion-induced release of metal ions by fixed orthodontic appliances (MBA) on the human immune system and salivary composition

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00027231
Enrollment
30
Registered
2022-01-31
Start date
2020-01-20
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

metal exposure and sensitization

Interventions

Group 1: Group G1 ("bonding group") Timepoint 1 (T1): Documentation: informed consent and confirmation of participation. General health interviews and collection of a general and specific medical hist
recording of the concentration of metals, toxic metals, plastic concentrations in the saliva, lymphocyte transformation test). "Banding" of the patient (insertion of the multibracket appliance in the
registration of the oral situation. Collection of 2 fasting morning saliva samples and 4 blood tubes (multi-element analysis
recording of concentration of metals, toxic metals, plastic concentrations in saliva, lymphocyte transformation test). Concentration changes from T1 to T4 are documented to detect possible differences

Sponsors

DEGUZ e. V. - Deutsche Gesellschaft für Umwelt-ZahnMedizin e. V.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Voluntary participation Healthy young patients; receive the fixed (mainly metallic) appliance or have it removed. Control group: patients without any metallic appliances or orthodontic treatment. Medications are documented. Oral hygiene and diet remain constant. Patients are instructed not to undergo any further dental treatment (e.g. fillings, dental cleanings) during this period. Additional, medically unnecessary intake of nutritional supplements or minerals is paused. Saliva samples are taken in the morning on an empty stomach (no eating, drinking or teeth brushing before). - metal - upper and lower jaw

Exclusion criteria

Exclusion criteria: Heavy smokers; patients unable to meet study timelines and criteria.

Design outcomes

Primary

MeasureTime frame
Effects on the body and the immune system should be shown.

Secondary

MeasureTime frame
Recommendations and preventive measures for the (orthodontic) treatment of different patients before or during multibracket therapy should be formulated. If there is evidence of health effects, an alternative or change in therapy should be made, especially for sensitized patients.

Countries

Germany

Contacts

Public ContactNusha Paschaei

Charité - Universitätsmedizin Berlin, CC3 Centrum für Zahn-, Mund- und Kieferheilkunde

nusha.paschaei@charite.de004917647601684

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026