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Completed

NCT Number: NCT04591080

A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

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.

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Key information

Conditions

Malocclusion, Angle Class I Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GUMMETAL Orthodontic Wire

Device

Orthodontic archwire made of TiNbTaZr alloy.

Other names: TiNbTaZr, Titanium-niobium, Beta-titanium,

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"

Primary outcomes

  1. Total Amount of Canine Retraction

    Time frame: 12 weeks

    Canine movement measured at distal marginal ridge

Secondary outcomes

  1. 3-Dimensional Control of Canine Movement Assessment

    Time frame: 12 weeks

    Canine position (tip, rotation, angulation) will be assessed from initial to final position

  2. Rate of Canine Retraction Per Month

    Time frame: 12 weeks

    Rate of canine retraction in mm per month

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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