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Immunological and Regenerative Implications of Corrosion of Dental Materials

NCT03334461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-26

No results posted yet for this study

Summary

During orthodontic treatment intraoral corrosion results with release of nickel and titanium ions from orthodontic appliances in surrounding tissues. Those transported in the saliva and blood may cause a series of side effects from hypersensitivity reactions and soft tissue proliferation to cyto and genotoxicity. Nickel is one of the strongest contact allergens, present in numerous dental alloys. The aim of this project is to investigate the immune potential of nickel and titan ions (development of allergies, changes in cariogenic potential of dental plaque, resistance of gingivitis to therapy, and bacterial resistance to antibiotics) and changes in performance of orthodontic appliances with repercussion on regeneration of bone and periodontal tissues.

Conditions

  • Caries; Enamel
  • Gingivitis

Interventions

COMBINATION_PRODUCT

Exposure to oral antiseptics or enamel remineralisation agent

Sponsors & Collaborators

  • Croatian Science Foundation

    collaborator OTHER_GOV

  • University of Rijeka

    lead OTHER

Principal Investigators

  • Stjepan Spalj, PhD · University of medicine Rijeka

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2022-03-30
Completion
2022-05-17

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03334461 on ClinicalTrials.gov