A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class I
• Intervention / Treatment: Device: GUMMETAL Orthodontic Wire; Device: Stainless Steel (CrNi)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • University at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GUMMETAL TiNbTaZr; 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; Orthodontic archwire made of TiNbTaZr alloy.; Other Names: TiNbTaZr, Titanium-niobium, Beta-titanium,
Active Comparator: 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"	Device: 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Amount of Canine Retraction	Canine movement measured at distal marginal ridge	12 weeks

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	12 weeks
Rate of Canine Retraction Per Month	Rate of canine retraction in mm per month	12 weeks

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Study Chair: Thikriat Al-Jewair, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: October 11, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class I
• Other Study ID Numbers: GMTSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not be sharing any IPD information with any other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No