Trial Outcomes & Findings for A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure (NCT NCT04591080)
NCT ID: NCT04591080
Last Updated: 2025-05-30
Results Overview
Canine movement measured at distal marginal ridge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-05-30
Participant Flow
This is a split-mouth pilot study. A total of 12 participants were enrolled. 24 adult canine teeth were randomized 1:1 to the control and intervention conditions (sides Rt vs Lt) resulting in 12 canines receiving the control treatment and 12 canines receiving the intervention. A total of 6 participants completed the study.6 canines receiving the control treatment and 6 canines receiving the intervention.
Unit of analysis: Right vs left canine
Participant milestones
| Measure |
Control
Control: 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". 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
This is a split-mouth study. Each subject was allocated to both the control and intervention groups. The unit of assessment is the right and left maxillary canine teeth.
Intervention: TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022". GUMMETAL Orthodontic Wire: Orthodontic archwire made of TiNbTaZr alloy.
|
|---|---|---|
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Overall Study
STARTED
|
12 12
|
12 12
|
|
Overall Study
COMPLETED
|
6 6
|
6 6
|
|
Overall Study
NOT COMPLETED
|
6 6
|
6 6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
This is a split-mouth study. Each subject was allocated to both the control and intervention groups. The unit of assessment is the right and left maxillary canine teeth.
Intervention: TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022". GUMMETAL Orthodontic Wire: Orthodontic archwire made of TiNbTaZr alloy.
Control: 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". 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"
|
|---|---|
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Age, Categorical
<=18 years
|
12 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
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0 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 2 canine teeth were assessed per subject (total of 6 subjects completed the study)
Canine movement measured at distal marginal ridge
Outcome measures
| Measure |
GUMMETAL TiNbTaZr
n=12 Canine teeth
TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022"
GUMMETAL Orthodontic Wire: Orthodontic archwire made of TiNbTaZr alloy.
|
Stainless Steel (CrNi)
n=12 Canine teeth
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"
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"
|
|---|---|---|
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Total Amount of Canine Retraction
|
3.41 mm
Interval 2.1 to 4.76
|
3.71 mm
Interval 1.62 to 6.45
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SECONDARY outcome
Timeframe: 12 weeksPopulation: 2 canine teeth per subject
Canine position (tip, rotation, angulation) will be assessed from initial to final position
Outcome measures
| Measure |
GUMMETAL TiNbTaZr
n=12 Canine teeth
TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022"
GUMMETAL Orthodontic Wire: Orthodontic archwire made of TiNbTaZr alloy.
|
Stainless Steel (CrNi)
n=12 Canine teeth
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"
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"
|
|---|---|---|
|
3-Dimensional Control of Canine Movement Assessment
|
7.90 degrees
Interval 6.74 to 8.99
|
7.25 degrees
Interval 6.71 to 8.16
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SECONDARY outcome
Timeframe: 12 weeksPopulation: 2 canine teeth per subject
Rate of canine retraction in mm per month
Outcome measures
| Measure |
GUMMETAL TiNbTaZr
n=12 Canine teeth
TiNbTaZr (Beta-Titanium) Alloy used to manufacture orthodontic archwires. We will be using an archwire with the size of 0.016 x 0.022"
GUMMETAL Orthodontic Wire: Orthodontic archwire made of TiNbTaZr alloy.
|
Stainless Steel (CrNi)
n=12 Canine teeth
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"
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"
|
|---|---|---|
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Rate of Canine Retraction Per Month
|
1.14 mm/month
Interval 0.69 to 1.59
|
1.42 mm/month
Interval 0.54 to 2.15
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thikriat Al-Jewair, Program Director
University at Buffalo
Phone: 17168296190
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place