Studies
| Study First Submitted Date | 2019-03-10 |
| Study First Posted Date | 2019-03-15 |
| Last Update Posted Date | 2021-05-11 |
| Start Month Year | October 2, 2017 |
| Primary Completion Month Year | January 31, 2020 |
| Verification Month Year | May 2021 |
| Verification Date | 2021-05-31 |
| Last Update Posted Date | 2021-05-11 |
Detailed Descriptions
| Sequence: | 20709243 |
| 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. |
Facilities
| Sequence: | 199956380 | Sequence: | 199956381 | Sequence: | 199956382 |
| Name | School of Dental Sciences | Name | Advanced Medical & Dental Institute | Name | Desa Murni Dental Clinic |
| City | Kubang Kerian | City | Kepala Batas | City | Permatang Pauh |
| State | Kelantan | State | Penang | State | Penang |
| Zip | 16150 | Zip | 13200 | Zip | 13500 |
| Country | Malaysia | Country | Malaysia | Country | Malaysia |
Conditions
| Sequence: | 52137101 |
| Name | Tooth Movement |
| Downcase Name | tooth movement |
Id Information
| Sequence: | 40133619 |
| Id Source | org_study_id |
| Id Value | USM/JEPeM/17010022 |
Countries
| Sequence: | 42541178 |
| Name | Malaysia |
| Removed | False |
Design Groups
| Sequence: | 55557222 | Sequence: | 55557223 | Sequence: | 55557224 | Sequence: | 55557225 |
| Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator |
| Title | RMO FLi® Tooth-coloured superelastic Nickel Titanium | Title | G&H G4 Tooth-coloured superelastic Nickel Titanium | Title | Orthocare Euroform® Cosmetic Tooth-coloured superelastic Nickel Titanium | Title | Conventional superelastic Nickel Titanium |
| Description | 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. | Description | 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. | Description | 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. | Description | This group has been allocated with conventional upper and lower round 0.014" superelastic Nickel Titanium archwires for a duration of 8 weeks. |
Interventions
| Sequence: | 52453021 | Sequence: | 52453022 |
| Intervention Type | Other | Intervention Type | Other |
| Name | Aesthetic archwires | Name | Control group |
| Description | 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. | Description | 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. |
Keywords
| Sequence: | 79819858 | Sequence: | 79819859 | Sequence: | 79819860 | Sequence: | 79819861 | Sequence: | 79819862 |
| Name | tooth alignment | Name | coating loss | Name | color change | Name | patient perception | Name | aesthetic archwire |
| Downcase Name | tooth alignment | Downcase Name | coating loss | Downcase Name | color change | Downcase Name | patient perception | Downcase Name | aesthetic archwire |
Design Outcomes
| Sequence: | 177257785 | Sequence: | 177257786 | Sequence: | 177257787 | Sequence: | 177257788 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Alignment efficiency | Measure | Coating loss | Measure | Color change | Measure | Participant perception towards aesthetic archwires |
| Time Frame | 8 weeks | Time Frame | 8 weeks | Time Frame | 8 weeks | Time Frame | 8 weeks |
| Description | 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. | Description | The amount of coating loss between the used and unused archwires will be measured in percentage. | Description | The difference in colour (colour change) between used and unused archwires will be measured in CIE L* a* b* colour space units. | Description | 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). |
Sponsors
| Sequence: | 48288918 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Universiti Sains Malaysia |
Overall Officials
| Sequence: | 29267217 |
| Role | Principal Investigator |
| Name | Anis F Kamaruddin, MOrth |
| Affiliation | Advanced Medical & Dental Institute |
Design Group Interventions
| Sequence: | 68105028 | Sequence: | 68105029 | Sequence: | 68105030 | Sequence: | 68105031 |
| Design Group Id | 55557223 | Design Group Id | 55557224 | Design Group Id | 55557222 | Design Group Id | 55557225 |
| Intervention Id | 52453021 | Intervention Id | 52453021 | Intervention Id | 52453021 | Intervention Id | 52453022 |
Eligibilities
| Sequence: | 30746590 |
| Gender | All |
| Minimum Age | 11 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | 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 Exclusion Criteria: Patients with cleft lip and palate and other craniofacial deformities and syndromes |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254113533 |
| Number Of Facilities | 3 |
| Registered In Calendar Year | 2019 |
| Actual Duration | 28 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | False |
| Minimum Age Num | 11 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 3 |
Designs
| Sequence: | 30492875 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Quadruple |
| Masking Description | 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. |
| Subject Masked | True |
| Caregiver Masked | True |
| Investigator Masked | True |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28859164 |
| Responsible Party Type | Principal Investigator |
| Name | Anis Kamaruddin |
| Title | Principal investigator |
| Affiliation | Universiti Sains Malaysia |
Study References
| Sequence: | 52030656 | Sequence: | 52030657 | Sequence: | 52030658 | Sequence: | 52030659 | Sequence: | 52030660 |
| Pmid | 8456786 | Pmid | 2378317 | Pmid | 21478301 | Pmid | 20139131 | Pmid | 7726464 |
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | 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. | Citation | 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. | Citation | 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. | Citation | 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. | Citation | 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. |
Ipd Information Types
| Sequence: | 3331316 | Sequence: | 3331317 |
| Name | Statistical Analysis Plan (SAP) | Name | Informed Consent Form (ICF) |