Tooth MovementRCTNCT03876184
Alignment Efficiency and Coating Durability of Aesthetic Archwires
A study testing Aesthetic archwires in people with Tooth Movement, run by Universiti Sains Malaysia at 3 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Movement
- What is being tested?
- Aesthetic archwires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesMalaysia
- Study dates
- 2 Oct 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites
Advanced Medical & Dental Institute
Kepala Batas, Pulau Pinang, 13200
School of Dental Sciences
Kubang Kerian, Kelantan, 16150
Desa Murni Dental Clinic
Permatang Pauh, Pulau Pinang, 13500
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Movement
- Being tested
- Aesthetic archwires, Control group
- Keywords
- tooth alignment, coating loss, color change, patient perception, aesthetic archwire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aesthetic archwiresOther
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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
Coating loss
The amount of coating loss between the used and unused archwires will be measured in percentage.
Measured: 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.
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start2 Oct 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anis Kamaruddin, Universiti Sains Malaysia
- Investigators
- Anis F Kamaruddin, MOrth, Principal investigator, Advanced Medical & Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876184
- Sponsor's protocol ID
- USM/JEPeM/17010022
- Acronym
- RCT
- Status last verified
- May 2021
- First submitted
- 10 Mar 2019
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication
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.
PubMed 8456786Kapila 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.
PubMed 2378317Farronato 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.
PubMed 21478301Demling 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.
PubMed 20139131De 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.
PubMed 7726464
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Alignment Efficiency and Coating Durability of Aesthetic Archwires
- ClinicalTrials.gov ID
- NCT03876184
- Acronym / sponsor ID
- RCT / USM/JEPeM/17010022
- Conditions
- Tooth Movement
- Keywords
- tooth alignment, coating loss, color change, patient perception, aesthetic archwire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RMO FLi® Tooth-coloured superelastic Nickel Titanium | Experimental | Other: Aesthetic archwiresThis 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. |
| G&H G4 Tooth-coloured superelastic Nickel Titanium | Experimental | Other: Aesthetic archwiresThis 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. |
| Orthocare Euroform® Cosmetic Tooth-coloured superelastic Nickel Titanium | Experimental | Other: Aesthetic archwiresThis 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. |
| Conventional superelastic Nickel Titanium | Active comparator | Other: Control groupThis group has been allocated with conventional upper and lower round 0.014" superelastic Nickel Titanium archwires for a duration of 8 weeks. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aesthetic archwiresDuring 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. | Other | G&H G4 Tooth-coloured superelastic Nickel Titanium, Orthocare Euroform® Cosmetic Tooth-coloured superelastic Nickel Titanium, RMO FLi® Tooth-coloured superelastic Nickel Titanium |
| Control groupDuring 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. | Other | Conventional superelastic Nickel Titanium |
Primary outcome
Alignment efficiency
Time frame: 8 weeks
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.
3 secondary outcomes
Coating loss
Time frame: 8 weeks
Color change
Time frame: 8 weeks
Participant perception towards aesthetic archwires
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 8456786Bass 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.
- Background: PubMed 2378317Kapila 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.
- Background: PubMed 21478301Farronato 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.
- Background: PubMed 20139131Demling 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.
- Background: PubMed 7726464De 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anis F Kamaruddin, MOrth principal investigator
Advanced Medical & Dental Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aesthetic archwires in people with Tooth Movement, run by Universiti Sains Malaysia at 3 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alignment efficiency (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876184, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.