A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

Malocclusion, Angle Class I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04591080
• Other study ID #: GMTSS
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class I

Intervention

Device:
• GUMMETAL Orthodontic Wire
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"

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Amount of Canine Retraction	Canine movement measured at distal marginal ridge	12 weeks
Secondary	3-Dimensional Control of Canine Movement Assessment	Canine position (tip, rotation, angulation) will be assessed from initial to final position	3 months
Secondary	Rate of Canine Retraction Per Month	Rate in mm per month	3 months