A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

NCT04591080 | Completed Results FDA Device

• 1 other identifier: GMTSS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion, Angle Class I

Outcome Measures

Primary Outcomes (1)

• Total Amount of Canine Retraction

  Canine movement measured at distal marginal ridge

  12 weeks

Secondary Outcomes (2)

• 3-Dimensional Control of Canine Movement Assessment

  12 weeks

• Rate of Canine Retraction Per Month

  12 weeks

Study Arms (2)

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"

Device: GUMMETAL Orthodontic Wire

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"

Device: Stainless Steel (CrNi)

Interventions

GUMMETAL Orthodontic Wire DEVICE

Orthodontic archwire made of TiNbTaZr alloy.

Also known as: TiNbTaZr, Titanium-niobium, Beta-titanium,

GUMMETAL TiNbTaZr

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"

Stainless Steel (CrNi)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Thikriat Al-Jewair, Program Director
• Organization: University at Buffalo

thikriat@buffalo.edu

17168296190

Study Officials

• Thikriat Al-Jewair

  University at Buffalo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontic Resident

Model Details: Split mouth design where one side of the mouth will be receiving the intervention and the other side of the mouth the control treatment.

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 19, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 30, 2025
• Results First Posted: April 19, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)