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Completed

NCT Number: NCT03334461

Immunological and Regenerative Implications of Corrosion of Dental Materials

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rijeka Faculty of Dental Medicine

Rijeka, 51000, Croatia

About this study

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:

  • the corrosion of dental materials and appliances based on nickel and titan (in saliva and due to interaction with probiotics, remineralising agents and antiseptics)
  • 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)
  • the effect of nickel and titan ions cellular level
  • changes in performance of dental appliances with repercussion on regeneration of bone and periodontal tissues.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients allergic to fluoride agents and chlorhexidine gluconate

Treatment and study plan

Exposure to oral antiseptics or enamel remineralisation agent

Combination Product

Primary outcomes

  1. Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents

    Time frame: 30 days

    Detection 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 outcomes

  1. Dental arch shape

    Time frame: 90 days

    Measuring 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.

  2. Oral hygiene

    Time frame: 210 days

    Assessing 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).

  3. pH of dental biofilm

    Time frame: 210 days

    Measuring pH of dental biofilm (colorimetric test with pH scale range from 4 to 7).

  4. Gingivitis

    Time frame: 210 days

    Assessing extent of gingivitis by Full Mouth Bleeding Score (percentage).

  5. Corrosion of dental alloy

    Time frame: 90 days

    Potential of corrosion, passive film breakdown and repassivation (mV)

  6. Surface roughness of dental alloy

    Time frame: 90 days

    Surface roughness assessed by Atomic Force Microscopy (nm)

  7. Friction of dental alloy

    Time frame: 90 days

    Friction coefficient (no units)

  8. Forces produced by dental alloy

    Time frame: 90 days

    Load and unload forces measured by three-point bend test (N)

  9. Hardness of dental alloy

    Time frame: 90 days

    Vickers Pyramid Number (HV)

  10. Stifness of dental alloy

    Time frame: 90 days

    Young's modulus and yield strength (GPa)

  11. Elasticity of dental alloy

    Time frame: 90 days

    Modulus of resilience and springback ratio (MJ/m-3)

Sponsors and collaborators

Lead sponsor

University of Rijeka

Other

Collaborators

  • Croatian Science Foundation

Registry information

Official study title

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

Acronym: IMUNODENT

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2017
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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