An interventional study of GUMMETAL Orthodontic Wire and Stainless Steel (CrNi) in Malocclusion, Angle Class I, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment
When there is space present between our teeth orthodontically we have the ability to close them through many methods. Using braces as our treatment modality this study will be investigating how efficient a new orthodontic wire is in closing tooth space. This new material is trade-named GUMMETAL and claims to have many benefits to treating patients orthodontically. We will be exploring its efficiency in space closure compared to an industry standard (stainless steel). We predict that the stainless-steel orthodontic wire will be more efficient at space closure than the new GUMMETAL wires.
This will be a randomized pilot split-mouth clinical trial of patients with spaces ≥ 3mm distal to the maxillary canines in need of closure through sliding mechanics. The sample consists of adolescent patients regardless of Angle's molar malocclusion who are receiving comprehensive full fixed appliance orthodontic treatment. Preformed conjoint archwires half being GUMMETAL and the other half SS, will be utilized. Each patient will have one side of the maxilla randomly allocated into the SS or GUMMETAL treatment group. The study will follow a split-mouth design to reduce the confounding variables from patient to patient on space closure mechanics. The maxillary arch in each subject will be randomized into a SS side or GM side using a random number generator. Spaces will be measured at; T0 is initial records, T1 is initiation of space closure, T2 will be 4 weeks after the initiation of space closure, T3 is another 4 weeks of space closure evaluation and T4 will be the final evaluation of space closure after 4 weeks from T3, via 3D intraoral scans of maxillary arches. Space measurement and calculations will utilize 3Shape software to measure the distance of canine movement based off the distal surface. Sliding mechanics will be activated through NiTi coil springs from the maxillary canines to the maxillary molars. The force will be standardized to 150 gms and will be measured each visit. The same provider will activate the NiTi coil spring for retraction, along with data collection. Superimposition of scans will be utilized to assess outcome measures.
Exclusion Criteria:
TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022"
Device: GUMMETAL Orthodontic Wire
Stainless steel (18% Chromium and 8% Nickel) used as the control, and linked anteriorly to the GUMMETAL counterpart. Size of archwire is 0.016 x 0.022"
Device: Stainless Steel (CrNi)
Orthodontic archwire made of TiNbTaZr alloy.
Also known as: TiNbTaZr, Titanium-niobium, Beta-titanium,
Stainless steel (18% Chromium and 8% Nickel) used as the control, and linked anteriorly to the GUMMETAL counterpart. Size of archwire is 0.016 x 0.022"
Total Amount of Canine Retraction
Canine movement measured at distal marginal ridge
Time frame: 12 weeks
3-Dimensional Control of Canine Movement Assessment
Canine position (tip, rotation, angulation) will be assessed from initial to final position
Time frame: 12 weeks
Rate of Canine Retraction Per Month
Rate of canine retraction in mm per month
Time frame: 12 weeks
| Milestone | Control | Intervention |
|---|---|---|
| Started | 12 | 12 |
| Completed | 6 | 6 |
| Not completed | 6 | 6 |
Canine movement measured at distal marginal ridge
| mm | GUMMETAL TiNbTaZr | Stainless Steel (CrNi) |
|---|---|---|
| Total Amount of Canine Retraction | 3.41 (2.10 to 4.76) | 3.71 (1.62 to 6.45) |
Canine position (tip, rotation, angulation) will be assessed from initial to final position
| degrees | GUMMETAL TiNbTaZr | Stainless Steel (CrNi) |
|---|---|---|
| 3-Dimensional Control of Canine Movement Assessment | 7.90 (6.74 to 8.99) | 7.25 (6.71 to 8.16) |
Rate of canine retraction in mm per month
| mm/month | GUMMETAL TiNbTaZr | Stainless Steel (CrNi) |
|---|---|---|
| Rate of Canine Retraction Per Month | 1.14 (0.69 to 1.59) | 1.42 (0.54 to 2.15) |
Collected over Throughout study completion: An average of 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 12 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 9 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
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Plan to share: No — We will not be sharing any IPD information with any other researchers.
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State University of New York at Buffalo