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A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

Primary Purpose

Malocclusion, Angle Class I

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GUMMETAL Orthodontic Wire
Stainless Steel (CrNi)
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class I

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GUMMETAL TiNbTaZr

Stainless Steel (CrNi)

Arm Description

TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022"

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"

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2020
Last Updated
December 14, 2022
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04591080
Brief Title
A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure
Official Title
A Comparison Between TiNbTaZr (GUMMETAL) and Stainless-steel Alloy for Space Closure With Sliding Mechanics A Pilot Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GUMMETAL TiNbTaZr
Arm Type
Experimental
Arm Description
TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022"
Arm Title
Stainless Steel (CrNi)
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
GUMMETAL Orthodontic Wire
Other Intervention Name(s)
TiNbTaZr, Titanium-niobium, Beta-titanium,
Intervention Description
Orthodontic archwire made of TiNbTaZr alloy.
Intervention Type
Device
Intervention Name(s)
Stainless Steel (CrNi)
Intervention Description
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 Outcome Measure Information:
Title
Maxillary canine retraction rate between GUMMETAL and SS archwires
Description
Rate (mm/month) calculated from initial to final data collection points between the intervention and control
Time Frame
3 months
Secondary Outcome Measure Information:
Title
3-Dimensional control of canine movement assessment
Description
Canine position (tip, rotation, angulation) will be assessed from initial to final position
Time Frame
3 months
Title
Total amount of retraction in millimeters
Description
total (initial to final data point collection)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thikriat Al-Jewair
Organizational Affiliation
University at Buffalo
Official's Role
Study Chair
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not be sharing any IPD information with any other researchers.

Learn more about this trial

A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

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