A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

NCT ID: NCT04591080

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-03-01

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.

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.

Conditions

Malocclusion, Angle Class I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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"

Group Type: EXPERIMENTAL

GUMMETAL Orthodontic Wire

Intervention Type: DEVICE

Orthodontic archwire made of TiNbTaZr alloy.

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"

Group Type: ACTIVE_COMPARATOR

Stainless Steel (CrNi)

Intervention Type: 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"

Interventions

GUMMETAL Orthodontic Wire

Orthodontic archwire made of TiNbTaZr alloy.

Intervention Type: 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"

Intervention Type: DEVICE

Other Intervention Names

TiNbTaZr, Titanium-niobium, Beta-titanium,

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Lubomyr Ravlyk

Orthodontic Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thikriat Al-Jewair

Role: STUDY_CHAIR

University at Buffalo

Locations

University at Buffalo

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

GMTSS

Identifier Type: -

Identifier Source: org_study_id