Malocclusion, Angle Class INCT04591080
A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure
A study testing GUMMETAL Orthodontic Wire and Stainless Steel (CrNi) in people with Malocclusion, Angle Class I, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class I
- What is being tested?
- GUMMETAL Orthodontic Wire and Stainless Steel (CrNi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between TiNbTaZr (GUMMETAL) and Stainless-steel Alloy for Space Closure With Sliding Mechanics A Pilot Randomized Clinical Trial
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.
Read the 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
- Being tested
- GUMMETAL Orthodontic Wire, Stainless Steel (CrNi)
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUMMETAL Orthodontic WireDevice
Also called TiNbTaZr, Titanium-niobium, Beta-titanium,
Orthodontic archwire made of TiNbTaZr alloy.
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"
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: 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" Receives: Device: Stainless Steel (CrNi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Canine Retraction
Canine movement measured at distal marginal ridge
Measured: 12 weeks
Secondary outcomes (2)
3-Dimensional Control of Canine Movement Assessment
Canine position (tip, rotation, angulation) will be assessed from initial to final position
Measured: 12 weeks
Rate of Canine Retraction Per Month
Rate of canine retraction in mm per month
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lubomyr Ravlyk, State University of New York at Buffalo
- Investigators
- Thikriat Al-Jewair, Study chair, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591080
- Sponsor's protocol ID
- GMTSS
- Status last verified
- May 2025
- First submitted
- 11 Oct 2020
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not be sharing any IPD information with any other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between TiNbTaZr (GUMMETAL) and Stainless-steel Alloy for Space Closure With Sliding Mechanics A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04591080
- Acronym / sponsor ID
- GMTSS
- Conditions
- Malocclusion, Angle Class I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GUMMETAL TiNbTaZr | Experimental | Device: GUMMETAL Orthodontic WireTiNbTaZr (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 (CrNi) | Active comparator | 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" |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Systemic diseases or syndrome
- Abnormalities in teeth size and/or shape
- Previous orthodontic treatment
- Anti-inflammatory medication
- Craniofacial anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUMMETAL Orthodontic WireAlso: TiNbTaZr, Titanium-niobium, Beta-titanium,Orthodontic archwire made of TiNbTaZr alloy. | Device | GUMMETAL TiNbTaZr |
| 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) |
Primary outcome
Total Amount of Canine Retraction
Time frame: 12 weeks
Canine movement measured at distal marginal ridge
2 secondary outcomes
3-Dimensional Control of Canine Movement Assessment
Time frame: 12 weeks
Rate of Canine Retraction Per Month
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We will not be sharing any IPD information with any other researchers.
Related trials for Malocclusion, Angle Class I
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Malocclusion Class II, Malocclusion, Angle Class I
Not yet recruiting
3D Printed Occlusal Splints for Intraoperative Use
Malocclusion, Angle Class I, Malocclusion, Angle Class II
Not yet recruiting
Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
Angle Class I Maloclussion, Dental Crowding
Recruiting
Clinical Performance of Direct-Printed Versus Thermoformed Aligners
Angle Class I Malocclusion, Dental Crowding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thikriat Al-Jewair study chair
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUMMETAL Orthodontic Wire and Stainless Steel (CrNi) in people with Malocclusion, Angle Class I, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Amount of Canine Retraction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.