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Immunological and Regenerative Implications of Corrosion of Dental Materials

Immunological and Regenerative Implications of Corrosion of Dental Materials in Children and Adolescents

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03334461
Acronym
IMUNODENT
Enrollment
60
Registered
2017-11-07
Start date
2015-12-01
Completion date
2022-05-17
Last updated
2022-05-26

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

Conditions

Caries; Enamel, Gingivitis

Keywords

Oral antiseptics, remineralisation agents

Brief 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.

Detailed description

Tooth movement with appliances based on nickel and titanium has got great osteogenic potential and can regenerate deficient parts of alveolar bone and gingiva and rehabilitate compromised occlusal relations and a patient's masticatory function. Due to the extended duration of this therapy, different procedures are carried out and materials are applied for prevention and regeneration of damaged enamel and oral mucosa. The oral cavity may be considered a galvanic cell in which dental alloys act as electrodes, while saliva and oral preventive and regenerative agents act as electrolites. The interaction causes corrosion, reduction of elasticity and increase of stiffness of appliances, which may in turn result in excessive forces, a disruption of tissue regeneration and irreparable damage of tooth roots, surrounding alveolar bone, periodontal ligament, gingiva and pulp. During the extended exposion, released corrosive products in surrounding tissues and those transported in saliva and blood may cause a series of side effects from hypersensitivity reactions and soft tissue proliferation to cyto and genotoxicity. Today, allergies are ever more frequent and arise earlier in life. A specific group are children and young adolescents in pubertal growth, a period in which the immune system develops. Nickel is one of the strongest contact allergens, present in numerous dental alloys. Nickel allergy is occurs in up to 28.5% of population and cannot be deemed as low potential risk anymore. In contrast, titan was considered a biocompatible material of no allergic potential. However, there is an increase in the frequency of presentations of different hypersensitivity reactions to titan, especially in patients with pacemakers. Numerous patients with hip endoprostheses, stents, dental implans and orthodontic appliances are exposed to titan. Titan allergy may be the cause of unexplained cases of failure and rejection of dental implants. Nickel and titan could cause bacterial resistance to antibiotics which may complicate treatment of a series of infections that are more frequent in children and adolescents. Regulations for safety of medical products regulate safety issues of materials through mandatory laboratory testing and expertise. However, the testing of interactions of these materials with newly formed materials for prevention of damage and regeneration of orodental tissues is not obligatory prior to the start of their commercial use. Such testing should be conducted by independent scientific insitutions and not by producers with direct commercial interest. The aim of this project is to investigate: 1. the corrosion of dental materials and appliances based on nickel and titan (in saliva and due to interaction with probiotics, remineralising agents and antiseptics) 2. the immune potential of nickel and titan ions (development of allergies, changes in cariogenic potential of dental plaque, resistency of gingivitis to therapy, and bacterial resistance to antibiotics) 3. the effect of nickel and titan ions cellular level 4. changes in performance of dental appliances with repercussion on regeneration of bone and periodontal tissues.

Interventions

COMBINATION_PRODUCTExposure to oral antiseptics or enamel remineralisation agent

Sponsors

Croatian Science Foundation
CollaboratorOTHER_GOV
University of Rijeka
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Unlabeled bottles containing testing agent

Intervention model description

Randomized controlled trail

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* patients with fixed orthodontic appliances * must be able to do a mouthwash

Exclusion criteria

* patients allergic to fluoride agents and chlorhexidine gluconate

Design outcomes

Primary

MeasureTime frameDescription
Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents30 daysDetection of change of count of Streptococcus mutans, sorbinus and salivarius and total bacterial count assesed by qPCR in the dental plaque before and after intervention in patients with fixed orthodontic appliances.

Secondary

MeasureTime frameDescription
Stifness of dental alloy90 daysYoung's modulus and yield strength (GPa)
Elasticity of dental alloy90 daysModulus of resilience and springback ratio (MJ/m-3)
Dental arch shape90 daysMeasuring anterior and posterior dental arch width (in millimeters), anterior depth and depth to width ratio in orthodontic patients wearing uncoated nickel-titanium 0.020''x0.020'' archwire on the day of putting the archwire and on the day of removing it.
Oral hygiene210 daysAssessing accumulation of dental biofilm with Modified Silness and Loe Plaque Index (0-3; 0=no plaque and 3=continuous line of dental bacterial plaque more than 1 millimetre).
pH of dental biofilm210 daysMeasuring pH of dental biofilm (colorimetric test with pH scale range from 4 to 7).
Hardness of dental alloy90 daysVickers Pyramid Number (HV)
Corrosion of dental alloy90 daysPotential of corrosion, passive film breakdown and repassivation (mV)
Surface roughness of dental alloy90 daysSurface roughness assessed by Atomic Force Microscopy (nm)
Friction of dental alloy90 daysFriction coefficient (no units)
Forces produced by dental alloy90 daysLoad and unload forces measured by three-point bend test (N)
Gingivitis210 daysAssessing extent of gingivitis by Full Mouth Bleeding Score (percentage).

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026