Immunological and Regenerative Implications of Corrosion of Dental Materials

Gingivitis Clinical Trial

— IMUNODENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334461
• Other study ID #: IP-2014-09-7500
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2015
• Est. completion date: May 17, 2022

Study information

• Verified date: May 2022
• Source: University of Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 17, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with fixed orthodontic appliances

• must be able to do a mouthwash

Exclusion Criteria:

• patients allergic to fluoride agents and chlorhexidine gluconate

Related Conditions & MeSH terms

• Caries; Enamel
• Gingivitis

Intervention

Combination Product:
• Exposure to oral antiseptics or enamel remineralisation agent

Locations

Country	Name	City	State
Croatia	University of Rijeka Faculty of Dental Medicine	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
University of Rijeka	Croatian Science Foundation

Country where clinical trial is conducted

Croatia, 

References & Publications (6)

Belasic TZ, Pejova B, Curkovic HO, Kamenar E, Cetenovic B, Spalj S. Influence of intraoral application of antiseptics and fluorides during orthodontic treatment on corrosion and mechanical characteristics of nickel-titanium alloy in orthodontic appliances — View Citation

Cindric L, Mohar Vitezic B, Zigante M, Spalj S, Markova Car E. Changes of bacterial profile of dental biofilm during orthodontic treatment and influence of fluorides and chlorhexidine. South Eur J Orthod Dentofac Res. Conference proceedings - 1st Congress

Zibar Belasic T, Mohar Vitezic B, Zigante M, Spalj S, Markova Car E. Supragingival biofilm composition changes during orthodontic treatment and chlorhexidine use. Book of Abstracts 97th Annual Congress of the European Orthodontic Society, Limassol, Cipar,

Zibar Belasic T, Pejova B, Otmacic Curkovic H, Kamenar E, Cetenovic B, Spalj S. Intraoral application of antiseptics and fluorides during orthodontic treatment does not affect significantly corrosion and mechanical characteristics of nickel-titanium alloy

Zibar Belasic T, Zigante M, Perkovic V, Uhac M, Spalj S. Comparison of dental and periodontal condition of patients unexposed and exposed to metal orthodontic appliance. Book of Abstracts of the 7th international Congress of School of Dental Medicine Univ

Zibar Belasic T, Zigante M, Uhac M, Karlovic S, Jelovica Badovinac I, Spalj S. Influence of intraoral application of antiseptics and fluorides during orthodontic treatment on biomechanics of remodeling of dental arches. 8th Virtual World Congress of Denta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents	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.	30 days
Secondary	Dental arch shape	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.	90 days
Secondary	Oral hygiene	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).	210 days
Secondary	pH of dental biofilm	Measuring pH of dental biofilm (colorimetric test with pH scale range from 4 to 7).	210 days
Secondary	Gingivitis	Assessing extent of gingivitis by Full Mouth Bleeding Score (percentage).	210 days
Secondary	Corrosion of dental alloy	Potential of corrosion, passive film breakdown and repassivation (mV)	90 days
Secondary	Surface roughness of dental alloy	Surface roughness assessed by Atomic Force Microscopy (nm)	90 days
Secondary	Friction of dental alloy	Friction coefficient (no units)	90 days
Secondary	Forces produced by dental alloy	Load and unload forces measured by three-point bend test (N)	90 days
Secondary	Hardness of dental alloy	Vickers Pyramid Number (HV)	90 days
Secondary	Stifness of dental alloy	Young's modulus and yield strength (GPa)	90 days
Secondary	Elasticity of dental alloy	Modulus of resilience and springback ratio (MJ/m-3)	90 days

External Links

•   all data concerning new project are available at link (Environmental factors and microbiological interactions in the structure of dental biofilm)
•   all data concerning research project are available at link (Immune and regenerative implications of corrosion of dental materials in children and adolescents)