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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GUMMETAL TiNbTaZr | Experimental | TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022" |
|
| Stainless Steel (CrNi) | Active Comparator | 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" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GUMMETAL Orthodontic Wire | Device | Orthodontic archwire made of TiNbTaZr alloy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Canine Retraction | Canine movement measured at distal marginal ridge | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 3-Dimensional Control of Canine Movement Assessment | Canine position (tip, rotation, angulation) will be assessed from initial to final position | 12 weeks |
| Rate of Canine Retraction Per Month | Rate of canine retraction in mm per month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thikriat Al-Jewair | University at Buffalo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States |
We will not be sharing any IPD information with any other researchers.
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This is a split-mouth pilot study.
A total of 12 participants were enrolled. 24 adult canine teeth were randomized 1:1 to the control and intervention conditions (sides Rt vs Lt) resulting in 12 canines receiving the control treatment and 12 canines receiving the intervention.
A total of 6 participants completed the study.6 canines receiving the control treatment and 6 canines receiving the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control: 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". Stainless Steel (CrNi): 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" |
| FG001 | Intervention | This is a split-mouth study. Each subject was allocated to both the control and intervention groups. The unit of assessment is the right and left maxillary canine teeth. Intervention: TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022". GUMMETAL Orthodontic Wire: Orthodontic archwire made of TiNbTaZr alloy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This is a split-mouth study. Each subject was allocated to both the control and intervention groups. The unit of assessment is the right and left maxillary canine teeth. Intervention: TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022". GUMMETAL Orthodontic Wire: Orthodontic archwire made of TiNbTaZr alloy. Control: 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". Stainless Steel (CrNi): 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" |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Amount of Canine Retraction | Canine movement measured at distal marginal ridge | 2 canine teeth were assessed per subject (total of 6 subjects completed the study) | Posted | Median | Inter-Quartile Range | mm | 12 weeks | Canine teeth | Canine teeth |
|
Throughout study completion: An average of 6 months
No risks anticipated
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | This is a split-mouth study: Each person was allocated a control and intervention sides (Right vs left maxillary canines). 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" TiNbTaZr (Beta-Titanium) Alloy size of 0.016 x 0.022" was used as the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thikriat Al-Jewair, Program Director | University at Buffalo | 17168296190 | thikriat@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2021 | Nov 14, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2020 | Nov 14, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008311 | Malocclusion, Angle Class I |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Split mouth design where one side of the mouth will be receiving the intervention and the other side of the mouth the control treatment.
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The participants will not know which intervention is on which side of their mouth, but will know that they are getting both types of interventions simultaneously, given the split-mouth design of the study.
| Stainless Steel (CrNi) | Device | 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" |
|
| 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Secondary | 3-Dimensional Control of Canine Movement Assessment | Canine position (tip, rotation, angulation) will be assessed from initial to final position | 2 canine teeth per subject | Posted | Median | Inter-Quartile Range | degrees | 12 weeks | Canine teeth | Canine teeth |
|
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| Secondary | Rate of Canine Retraction Per Month | Rate of canine retraction in mm per month | 2 canine teeth per subject | Posted | Median | Inter-Quartile Range | mm/month | 12 weeks | Canine teeth | Canine teeth |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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