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A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04591080
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
15.9
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: GUMMETAL Orthodontic Wire
  • Device: Stainless Steel (CrNi)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention 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.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:
Single (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.
Primary Purpose:
Treatment
Official Title:
A Comparison Between TiNbTaZr (GUMMETAL) and Stainless-steel Alloy for Space Closure With Sliding Mechanics A Pilot Randomized Clinical Trial
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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"

    Outcome Measures

    Primary Outcome Measures

    1. Maxillary canine retraction rate between GUMMETAL and SS archwires [3 months]

      Rate (mm/month) calculated from initial to final data collection points between the intervention and control

    Secondary Outcome Measures

    1. 3-Dimensional control of canine movement assessment [3 months]

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

    2. Total amount of retraction in millimeters [3 months]

      total (initial to final data point collection)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University at Buffalo Buffalo New York United States 14214

    Sponsors and Collaborators

    • State University of New York at Buffalo

    Investigators

    • Study Chair: Thikriat Al-Jewair, University at Buffalo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lubomyr Ravlyk, DDS, Orthodontic Resident, State University of New York at Buffalo
    ClinicalTrials.gov Identifier:
    NCT04591080
    Other Study ID Numbers:
    • GMTSS
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Malocclusion
    Malocclusion, Angle Class I

    Study Results

    No Results Posted as of Apr 11, 2022