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5.



Title of the topic:

Nickel release from stainless steel and nickel titanium archwires from simulated fixed orthodontic appliances- A comparative in vitro study.



6.




Brief resume of intended work:

6.1 Need for the study


Nickel, a primary component of orthodontic brackets, bands and wires, is a potential allergen and a common cause of allergic dermatitis. The harmful effects of nickel have been systematically investigated at the cell, tissue, organ and organism levels. Nickel complexes in the form of arsenides and sulphides have long been known to be carcinogenic, allergenic and mutating substances even at nontoxic concentrations. Nickel might induce DNA alterations mainly through base damage and DNA-strand scission.

Fixed orthodontic appliances usually include brackets, bands and archwires made of stainless steel containing approximately 8% to 12% nickel or nickel-titanium where nickel content exceeds 50%. Hence the release of nickel from these appliances may increase the frequency of hypersensitivity in already nickel sensitive individuals.

The purpose of this study is to estimate and compare the quantity of release of nickel from commonly used stainless steel and nickel titanium archwires into artificial saliva over a period of three months with the use of simulated fixed orthodontic appliances





6.2 Review of Literature





  1. Chung-Ju Hwang, Ji-Soo Shin, Jung-Yul Cha. Metal release from simulated fixed orthodontic appliances. Am J Orthod Dentofacial Orthop 2001;120:383-391

This in vitro study was done to measure metal released from simulated fixed orthodontic appliances with stainless steel and Niti archwires. Conclusion was that chromium, nickel and iron was released consistently up to 2 weeks from all four groups and it ranged till 8 weeks in few groups.




  1. Maja Kuhta, Dubravco Pavlin, Martina Slaj, Suzana Varga, Marina Lapter-Varga, Mladen Slaj. Type of archwire and level of acidity: Effects on release of metal ions from orthodontic appliances. Angle Orthod. 2009; 79:102-110.

This in vitro study examines the effects of 3 parameters- pH value, type of archwire and length of immersion on release of metal ions from orthodontic appliances. Stainless steel, Niti and thermo Niti archwires were used. Results showed pH had a very strong effect on release of ions and largest number of ions was released during the first week of appliance immersion.





  1. Heidi Kerosuo, Grete Moe, Erik Kleven. In vitro release of nickel and chromium from different types of simulated orthodontic appliances. Angle Orthod 1995; 65(2)111-116.

In this study samples consisting of a fixed appliance, a headgear and quadhelix were immersed in saline for 7 days. Similar control appliances were subjected to dynamic test conditions. Significant release of nickel was detected from quad helix than from other appliances in static conditions. Fixed appliance under dynamic conditions showed higher nickel release than the similar appliance in static conditions.




  1. Theodore Eliades, Spiros Zinelis, Moschos A. Papadopoulos, George Eliades, Athanasios E.Athanasios. Nickel content of As-Received and Retrieved Niti and Stainless Steel archwires: Assessing the nickel release hypothesis. Angle Orthod 2004;74:151-154

This study assesses the nickel content of new and recycled stainless steel and Niti archwire alloys. New and recycled archwires were subjected to scanning electron microscopy and energy- dispersive electron probe microanalysis .No changes were detected with respect to nickel content ratios between new and recycled Niti or stainless steel wires.



  1. Guiherme.P.Janson, Eduardo Alvares, Alberto Consolaro, Donald.g.Woodside, Marcos Roberto de Freitas. Nickel hypersensitivity reaction before, during and after orthodontic therapy. Am J Orthop 1998;113:655-60

The objectives of this cross sectional study were to determine the prevalence of nickel hypersensitivity reaction in orthodontic patients. The results were orthodontic treatment did not induce nickel hypersensitivity, hypersensitivity was seen more in females than males, there is an association between history of allergic reaction and use of metallic objects in contact with skin with nickel hypersensitivity.


6.3 Objective of the study:

The objective of this study is to estimate the quantity and compare nickel release from two types of stainless steel and two types of Niti archwires in artificial saliva at various time intervals over a period of 3 months.


7.




Materials and Methods:
7.1 Source of Data

JOURNALS –




  1. American Journal of Orthodontics and Dentofacial Orthopaedics




  1. Angle Orthodontist




  1. Journal of Orthodontics




  1. European journal of Orthodontics




  1. Biomaterials




  1. Orthodontics and Craniofacial research

STASTISTICAL DATA-




  1. Machin D, Campbell M, Fayers P, Pinol A, 1997 ,Sample

Size tables for clinical studies, 2nd edition.




  1. Zar Jerrold M, 1984, Biostatical analysis, 2nd edition.



    1. Method of collection of Data

To measure nickel release from fixed orthodontic appliances, 60 simulated fixed appliances are fabricated. These are divided into four groups of 15 each, two containing stainless steel archwires and two containing Niti archwires.

Group A-Stainless steel , 0.016x0.022-inch (Dentaurum)

Group B-Stainless steel, 0.016x0.022-inch (American Orthodontics)

Group C- copper Niti, 0.016x0.022-inch (Ormco)

Group D- Niti, 0.016x0.022-inch ( American Orthodontics)

Each simulated appliance is made to represent half of the maxillary arch and is fabricated on a stainless steel band material.

Stainless steel brackets of central incisor, canine, first and second premolars are welded at one point on the band and molar tubes of maxillary 1st and 2nd molars are welded at two points on the band, simulating clinical welding. The maxillary lateral incisor bracket is not welded instead ligated with 0.010-inch stainless steel ligature wires. Sixty such appliances are fabricated and divided into four groups and corresponding archwires are attached to the appliance.

The appliances are washed with distilled water and dried. After which each appliance is immersed in 50ml of artificial saliva in polyethylene tubes and sealed and maintained at 37⁰C in an incubator.


To measure the quantity of nickel in saliva inductively coupled plasma mass spectrometer is used.
Plan for data analysis

The saliva is analysed for quantity of nickel from each sample of Group A, B, C and D after 1 day, 7 days, 4 weeks, 8 weeks and 12 weeks.

A mean of the measurements within each group is taken at each time interval. At the end of 12 weeks a graph is plotted to analyse the difference in concentrations of nickel released by every group at various times.

To compare the values between Group A with Group B and Group C with Group D the Paired-T test is applied.


Inclusion criteria:





  1. Sixty simulated fixed orthodontic appliances each represent half of the maxillary dentition.




  1. Four types of archwires of 0.016x0.022-inch.




  1. Artificial saliva.


Exclusion criteria:

-


7.3

Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Not applicable

7.4

Has ethical clearance been obtained from your institution in case of 7.3?

Yes ethical clearance has been taken from the ethical committee.



8.

List of References:
1. Jia-Kuang Liu, Tzer-Min Lee, I-Hua Liu. Effect of loading force on dissolution behaviour and surface properties of nickel-titanium orthodontic archwires in artificial saliva .Am J Orthod Dentofacial Orthop 2011;140:166-76
2. Madhumita Natarajan, Sridevi Padmanabhan, Arun Chitranjan, Malathi Narasimham. Evaluation of the genotoxic effects of fixed appliances on oral mucosal cells and the relationship to nickel and chromium concentrations: An in vivo study. Am J Orthod Dentofacial Orthop 2011;140: 383-388
3. Antonio Jose Ortiz, Esther Fernandez, Ascension Vicente, Jose L Calvo, Clara Ortiz. Metallic ions released from stainless steel nickel-free and titanium orthodontic alloys: Toxicity and DNA damage. Am J Orthod Dentofacial orthop 2011; 140: e115-e122.
4. Nivedita Sahoo, Vignesh Kailasam, Sridevi Padmanabhan, Arun Chitranjan. In-vivo evaluation of salivary nickel and chromium levels in conventional and self-ligating brackets. Am J Orthod Dentofacial Orthop 2011;140:340-5
5. Maria Francesca Sfondrini, Vittorio Cacciafesta, Elena Maffia, Andrea Scribante, Giancarla Alberti, Raffaela Biesuz. Nickel release from new conventional stainless steel, recycled and nickel-free orthodontic brackets: An in vitro study. Am J Orthod Dentofacial Orthop 2010;137:809-15
6. Tzu-Hsin Lee, Ta-Ko Huang, Shu-Yuan Lin, Li-Kai Chen, Ming Yung Chou. Corrosion resistance of different nickel-titanium archwires in acidic fluoride containing artificial saliva. Angle orthod 2010;80 no.3:547-553
7. Camila Alessandra Pazzini, Gilberto Oliveira, Leandro Silva, Cassio Vicente, Luciano Jose. Prevalence of nickel allergy and longitudinal evaluation of periodontal abnormalities in orthodontic allergic patients. Angle Orthod. 2009;79: 922-927
8. S Luft, L Keilig, A Jager, C Bourauel. In-vitro evaluation of corrosion behaviour of orthodontic brackets. Orthod Craniofac Res 2009; 12:43-51.
9. Evangelia Petoumenou,Martin Arndt, Ludger Keilig, Suzanne Reimann, Hildegard Hoederath, Theodore Eliades, Andreas Jager, Christoph Bourauel. Nickel concentration in the saliva of patients with nickel titanium orthodontic appliances. Am J Orthod Dentofacial Orthop 2009;135:59-65
10. F.Amini, A Borzabadi Farahani, A Jafari, M Rabbani. In vivo study of metal content of oral mucosa cells in patients with and without fixed orthodontic appliances. Orthod Craniofac Res 2008;11:51-56
11. Olga-Elpis Kolokitha, Eleftherios G. Kaklamanos, M.A.Papadopoulos. Prevalence of nickel hypersensitivity in orthodontic patients: A meta-analysis. Am J Orthod Dentofacial Orthop 2008;134:722.e1-722.e12
12. Cassio Vicente Pereira, Estela Kaminagakura, Paulo Rogerio, Renata Avelar. Cellular, Humoral and Histopathologic analysis in rats implanted with orthodontic nickel brackets. Angle orthod 2008;78:114-119
13. Rodrigo Matos de Souza, Luciane Macedo de Menezes. Nickel, chromium and iron levels in the saliva of patients with simulated fixed orthodontic appliances. Angle orthod 2008;78: 345-50
14. Ulvi Kahraman Gursoy, Oral Sokucu, Veli Jukka Uitto, Ahmit Aydin. The role of nickel accumulation and epithelial cell proliferation in orthodontic treatment induced gingival overgrowth. Eur J of Orthod 2007;29:555-558
15. Luciane Macedo Menezes, Catia Abdo Quintao, Ana Maria Bolognese. Urinary excretion levels of nickel in orthodontic patients. Am J Orthod Dentofacial Orthop 2007; 131: 635-638
16. Ronny Fors, Maurits Persson. Nickel in dental plaque and saliva in patients with and without orthodontic appliances. Eur J of Orthod 2006; 28: 292-297
17. Keun-Taek Oh, Kyoung-Nam Kim. Ion release and cytotoxicity of stainless steel wires. Eur J of Orthod 2005;27,533-540
18. Seda Gursoy, Ahu Gungor, Cagla Sesen. Comparison of metal release from new and recycled bracket-archwire combinations. Angle orthod 2004; 75:92-94
19. Tsui Hsein Huang, Shinn Jyh Ding, Yan Min, Chia Tze Kao. Metal ion release from new and recycled stainless steel brackets. Eur J of Orthod 2004; 26:171-177
20. Luciane Menezes, Luis Campos, Catia Quintao, Ana Bolognese. Hypersensitivity to metals in orthodontics. Am J Orthod Dentofacial Orthop 2004;126:58-64
21. Her Hsiung Huang, Yu Hui Chiu, Tzu-Hsin Lee, Shih- Ching Wu, Hui Wen Yang, Kuo-Hsiung Su, Chii-Chih Hsu. Ion release from Niti orthodontic wires in artificial saliva with various acidities. Biomaterials 2003; 24;3585-3592
22. Fiorenzo Faccioni, Paola Franceschetti, Marzia Cerpelloni, Maria Fracasso. In vivo study on metal release from fixed orthodontic appliances and DNA damage in oral mucosa cells .Am J Dentofacial Orthop 2003;124:687-694
23. Theodore Eliades, Christos Trapalis, George Eliades, Elias Katsavrias. Salivary metal levels of orthodontic patients: a novel methodological and analytical approach. Eur J of Orthod 2003;25:103-106
24. G.Rahilly, N.Price. Nickel allergy and orthodontics. Journal of orthodontics 2003;30;171-174
25. Theodore Eliades, Spiros Zinelis, George Eliades, Athanasios E. Athenasiou. Nickel content of as-received, retrieved and recycled stainless steel brackets. Am J Orthod Dentofacial Orthop 2002;122:217-220
26. Theodore Eliades, Athanasios E. Athanasiou. In vivo aging of orthodontic alloys: Implications for corrosion potential, nickel release and biocompatibility. Angle Orthod 2002;72:222-237
27. Gunseli Agaoglu, Tulin Arun, Belgin Izgu. Nickel and chromium levels in saliva and serum of patients with fixed orthodontic appliances. Angle Orthod 2001;71:375-379
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