Alignment Efficiency and Coating Durability of Aesthetic Archwires (RCT)

Randomised Controlled Trial of the Alignment Efficiency and Coating Durability of Aesthetic Archwires

This study investigates the efficiency of orthodontic aesthetic archwires which are coated with tooth-colored materials and the durability of the coatings after being used. Theoretically, the coatings provide excellent aesthetics throughout treatment and faster tooth alignment. However, from our clinical experience, these claims are the opposite. Cracks and ruptures as well as archwire fractures have been noted. Therefore, it is presumed that the aesthetic archwires may not be any different from the conventional uncoated archwires.

Study Overview

• Status: Completed
• Conditions: Tooth Movement
• Intervention / Treatment: Other: Aesthetic archwires; Other: Control group

Detailed Description

The development of superelastics nickel titanium (SE NiTi) has overcome problems with previous aligning archwires. This archwire is deemed to be the gold standard aligning archwire for Straight Wire® system due to its shape memory effect, high elasticity and low permanent deformation which delivers continuous force for orthodontic tooth alignment. The only drawbacks of this wire type are it is expensive, have high frictional resistance (Kapila et al., 1990) and is associated with hypersensitivity reaction in nickel allergic patients (Bass et al., 1993).

Development of teflon or polytetrafluoroethylene (PTFE) which is anti-adherent and possesses aesthetic property had been used as orthodontic bracket, archwire and ligature coating. This polymer consists of synthetic fluorine-containing resin or epoxy resin composed mainly of polytetrafluoroethylyene to simulate tooth colour. The polymeric chain with good mechanical stability had been shown to reduce the frictional resistance between bracket-archwire interface and when used as archwire ligature (Farronato et al., 2012, De Franco et al., 1995). PTFE-coated brackets were reported to minimise the formation of biofilm during treatment which can reduce the risk of enamel decalcification (Demling et al., 2010). Furthermore, the coated aesthetic archwires have potential to obviate any allergic reaction during orthodontic treatment in patients with known hypersensitivity to nickel alloy.

Manufacturers have claimed that the aesthetic archwires available in the market have good color stability (remains unchanged for 6 to 8-week duration), good coating durability and low friction, allowing faster tooth movement. However, to our experience, these claims are the opposite.

As these aesthetic archwires are much more expensive than the conventional superelastic nickel titanium, it is therefore important to establish a clinical data to allow clinicians and patients to make a justifiable choice on treatment and develop further research in this area.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • School of Dental Sciences
  • Penang
    • Kepala Batas, Penang, Malaysia, 13200
      • Advanced Medical & Dental Institute
    • Permatang Pauh, Penang, Malaysia, 13500
      • Desa Murni Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient aged 11 years old and above in permanent dentition with all teeth from upper and lower 6 - 6 are present, tooth apices are closed
• Patients who require complete bond-up with upper and lower pre-adjusted edgewise bracket system, MBT prescription with bracket slot size 0.022"
• Able to give consent* *Assent form is required for children below 18 years of age

Exclusion Criteria:

• Patients with cleft lip and palate and other craniofacial deformities and syndromes
• Patients with medical problems / medications that can influence rate of tooth movement
• Teeth blocked out of the arch / ectopic teeth not allowing bracket placement and ligation at bond-up
• Hypodontia with more than one tooth missing in any quadrant
• Have had orthodontic treatment before

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RMO FLi® Tooth-coloured superelastic Nickel Titanium; This group has been allocated with upper and lower round 0.014" RMO FLi® Tooth-coloured superelastic Nickel Titanium aesthetic archwires for a duration of 8 weeks.	Other: Aesthetic archwires; During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.Questionnaires will be answered by participants.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.
Experimental: G&H G4 Tooth-coloured superelastic Nickel Titanium; This group has been allocated with upper and lower round 0.014" G&H G4 Tooth-coloured superelastic Nickel Titanium aesthetic archwires for a duration of 8 weeks.	Other: Aesthetic archwires; During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.Questionnaires will be answered by participants.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.
Experimental: Orthocare Euroform® Cosmetic Tooth-coloured superelastic Nickel Titanium; This group has been allocated with upper and lower round 0.014" Orthocare Euroform® Cosmetic Tooth-coloured superelastic Nickel Titanium aesthetic archwires for a duration of 8 weeks.	Other: Aesthetic archwires; During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.Questionnaires will be answered by participants.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.
Active Comparator: Conventional superelastic Nickel Titanium; This group has been allocated with conventional upper and lower round 0.014" superelastic Nickel Titanium archwires for a duration of 8 weeks.	Other: Control group; During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.This group will not answer the questionnaire.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alignment efficiency	The tooth irregularity between pre- and post-experiment dental casts are measured in millimetres. The difference between the two measurement will be calculated in percentage.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coating loss	The amount of coating loss between the used and unused archwires will be measured in percentage.	8 weeks
Color change	The difference in colour (colour change) between used and unused archwires will be measured in CIE L* a* b* colour space units.	8 weeks
Participant perception towards aesthetic archwires	Patient perception will be assessed using oral aesthetic subjective impact scale (OASIS) questionnaires after the use of aesthetic archwires (at week 8). The cumulative score will be used to determine the perception (14 and below = positive perception; 15 and above = negative perception).	8 weeks

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Anis F Kamaruddin, MOrth, Advanced Medical & Dental Institute

Publications and helpful links

General Publications

• Bass JK, Fine H, Cisneros GJ. Nickel hypersensitivity in the orthodontic patient. Am J Orthod Dentofacial Orthop. 1993 Mar;103(3):280-5. doi: 10.1016/0889-5406(93)70009-D.
• Kapila S, Angolkar PV, Duncanson MG Jr, Nanda RS. Evaluation of friction between edgewise stainless steel brackets and orthodontic wires of four alloys. Am J Orthod Dentofacial Orthop. 1990 Aug;98(2):117-26. doi: 10.1016/0889-5406(90)70005-W.
• Farronato G, Maijer R, Caria MP, Esposito L, Alberzoni D, Cacciatore G. The effect of Teflon coating on the resistance to sliding of orthodontic archwires. Eur J Orthod. 2012 Aug;34(4):410-7. doi: 10.1093/ejo/cjr011. Epub 2011 Apr 8.
• Demling A, Elter C, Heidenblut T, Bach FW, Hahn A, Schwestka-Polly R, Stiesch M, Heuer W. Reduction of biofilm on orthodontic brackets with the use of a polytetrafluoroethylene coating. Eur J Orthod. 2010 Aug;32(4):414-8. doi: 10.1093/ejo/cjp142. Epub 2010 Feb 5.
• De Franco DJ, Spiller RE Jr, von Fraunhofer JA. Frictional resistances using Teflon-coated ligatures with various bracket-archwire combinations. Angle Orthod. 1995;65(1):63-72; discussion 73-4. doi: 10.1043/0003-3219(1995)0652.0.CO;2.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: March 10, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: tooth alignment; patient perception; color change; coating loss; aesthetic archwire
• Other Study ID Numbers: USM/JEPeM/17010022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in publication
• IPD Sharing Time Frame: 6 months after publication.
• IPD Sharing Access Criteria: Describe by what Access criteria IPD and any additional supporting information will be shared through email with other researchers. Principal investigator will review requests prior to data sharing.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No