Immunological and Regenerative Implications of Corrosion of Dental Materials
NCT ID: NCT03334461
Last Updated: 2022-05-26
Study Results
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Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2015-12-01
2022-05-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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high concentration enamel remineralisation agent
first month brushing teeth three times per day: twice per day with high-fluorides gel (Mirafluor K gel cola 6150 ppm F pH 5.1) and once per day without toothpaste and fluoride gel next two months brushing teeth three times per day with toothpaste containing low concentration of fluorides (1450 ppm)
Exposure to oral antiseptics or enamel remineralisation agent
oral antiseptic
first month brushing teeth without toothpaste three times per day and using oral antiseptic chlorhexidine mouthwash (Curasept ADS 212 a 200ml 0,12%) twice per day next two months brushing teeth three times per day with toothpaste containing low concentration of fluorides (1450 ppm)
Exposure to oral antiseptics or enamel remineralisation agent
Control
regular oral hygiene without exposure to oral antiseptic or high concentration enamel remineralisation agent three months brushing teeth three times per day with toothpaste containing low concentration of fluorides (1450 ppm)
No interventions assigned to this group
Interventions
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Exposure to oral antiseptics or enamel remineralisation agent
Eligibility Criteria
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Inclusion Criteria
* must be able to do a mouthwash
Exclusion Criteria
ALL
Yes
Sponsors
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Croatian Science Foundation
OTHER_GOV
University of Rijeka
OTHER
Responsible Party
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Stjepan Spalj
Full Professor
Principal Investigators
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Stjepan Spalj, PhD
Role: PRINCIPAL_INVESTIGATOR
University of medicine Rijeka
Locations
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University of Rijeka Faculty of Dental Medicine
Rijeka, , Croatia
Countries
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References
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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. Angle Orthod. 2021 Jul 1;91(4):528-537. doi: 10.2319/052620-480.1.
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 University of Zagreb, Rovinj, Croatia, 21.-22.05.2021. Acta Stomatol Croat. 2021;55:213-6.
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 Dental Students - Abstract book. Zagreb, Croatia, 2020. p. 2.
Cindric L, Mohar Vitezić 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 of the Faculty of Dental medicine, University of Rijeka, Croatia, October 1st-3rd 2020. Rijeka, Hrvatska, 2020. p. 55.
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 in orthodontic appliances. Prvi kongres Fakulteta dentalne medicine Sveučilišta u Rijeci, Rijeka, 1-2.10.2020. Knjiga sažetaka. South Eur J Orthod Dentofac Res 2020;7:56.
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, 30.05.-03.06.2022.
Related Links
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all data concerning research project are available at link (Immune and regenerative implications of corrosion of dental materials in children and adolescents)
all data concerning new project are available at link (Environmental factors and microbiological interactions in the structure of dental biofilm)
Other Identifiers
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IP-2014-09-7500
Identifier Type: -
Identifier Source: org_study_id
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