A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Comparison Between TiNbTaZr (GUMMETAL) and Stainless-steel Alloy for Space Closure With Sliding Mechanics A Pilot Randomized Clinical Trial

Conditions
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Malocclusion, Angle Class I

Intervention / Treatment
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* Device: GUMMETAL Orthodontic Wire
* Device: Stainless Steel (CrNi)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full permanent dentition (except third molars) Good general and oral health Bilateral spaces 3 >/= mm distal to the maxillary canines Normal and hypodivergent growth pattern Any dental malocclusion Good Oral Hygiene Exclusion Criteria: Systemic diseases or syndrome Abnormalities in teeth size and/or shape Previous orthodontic treatment Anti-inflammatory medication Craniofacial anomalies Hyperdivergent growth pattern Periodontal disease / attachment loss exceeding 25% of root length Significant pre or in-treatment root resorption

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Split mouth design where one side of the mouth will be receiving the intervention and the other side of the mouth the control treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GUMMETAL TiNbTaZr<br>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<br>* Orthodontic archwire made of TiNbTaZr alloy.<br>* Other names: TiNbTaZr, Titanium-niobium, Beta-titanium,;|
| Active Comparator: Stainless Steel (CrNi)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maxillary canine retraction rate between GUMMETAL and SS archwires | Rate (mm/month) calculated from initial to final data collection points between the intervention and control | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-Dimensional control of canine movement assessment | Canine position (tip, rotation, angulation) will be assessed from initial to final position | 3 months | 
| Total amount of retraction in millimeters | total (initial to final data point collection) | 3 months |