Alignment Efficiency and Coating Durability of Aesthetic Archwires

NCT03876184 | Completed DMC

• 1 other identifier: USM/JEPeM/17010022
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Tooth Movement

Keywords

tooth alignment; coating loss; color change; patient perception; aesthetic archwire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Coating loss

  8 weeks

• Color change

  8 weeks

• Participant perception towards aesthetic archwires

  8 weeks

Study Arms (4)

RMO FLi® Tooth-coloured superelastic Nickel Titanium

EXPERIMENTAL

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

G&H G4 Tooth-coloured superelastic Nickel Titanium

EXPERIMENTAL

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

Orthocare Euroform® Cosmetic Tooth-coloured superelastic Nickel Titanium

EXPERIMENTAL

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

Conventional superelastic Nickel Titanium

ACTIVE COMPARATOR

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

Interventions

Aesthetic archwires OTHER

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.

G&H G4 Tooth-coloured superelastic Nickel Titanium; Orthocare Euroform® Cosmetic Tooth-coloured superelastic Nickel Titanium; RMO FLi® Tooth-coloured superelastic Nickel Titanium

Control group OTHER

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.

Conventional superelastic Nickel Titanium

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (3)

School of Dental Sciences

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Advanced Medical & Dental Institute

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Desa Murni Dental Clinic

Permatang Pauh, Pulau Pinang, 13500, Malaysia

Location

Related Publications (5)

• 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.

  PMID: 8456786 BACKGROUND

• 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.

  PMID: 2378317 BACKGROUND

• 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.

  PMID: 21478301 BACKGROUND

• 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.

  PMID: 20139131 BACKGROUND

• 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.

  PMID: 7726464 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anis F Kamaruddin, MOrth

  Advanced Medical & Dental Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will select only one sealed envelope containing the archwires which has been labelled and coded without looking at other archwires. Both operators and participants are not informed of the brands of the coated archwires. The statistician will analyse the data based on the assigned codes. The codes will be broken by the principal investigator after the results have been produced.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 15, 2019
• Study Start: October 2, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 6 months after publication.
• 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.

Locations

MY (3)