Malocclusion, Angle Class I
Conditions
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.
Interventions
DEVICEGUMMETAL Orthodontic Wire
Orthodontic archwire made of TiNbTaZr alloy.
DEVICEStainless 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
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Canine Retraction | 12 weeks | Canine movement measured at distal marginal ridge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-Dimensional Control of Canine Movement Assessment | 12 weeks | Canine position (tip, rotation, angulation) will be assessed from initial to final position |
| Rate of Canine Retraction Per Month | 12 weeks | Rate of canine retraction in mm per month |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 12 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Total Amount of Canine Retraction
Canine movement measured at distal marginal ridge
Time frame: 12 weeks
Population: 2 canine teeth were assessed per subject (total of 6 subjects completed the study)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GUMMETAL TiNbTaZr | Total Amount of Canine Retraction | 3.41 mm |
| Stainless Steel (CrNi) | Total Amount of Canine Retraction | 3.71 mm |
Secondary
3-Dimensional Control of Canine Movement Assessment
Canine position (tip, rotation, angulation) will be assessed from initial to final position
Time frame: 12 weeks
Population: 2 canine teeth per subject
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GUMMETAL TiNbTaZr | 3-Dimensional Control of Canine Movement Assessment | 7.90 degrees |
| Stainless Steel (CrNi) | 3-Dimensional Control of Canine Movement Assessment | 7.25 degrees |
Secondary
Rate of Canine Retraction Per Month
Rate of canine retraction in mm per month
Time frame: 12 weeks
Population: 2 canine teeth per subject
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GUMMETAL TiNbTaZr | Rate of Canine Retraction Per Month | 1.14 mm/month |
| Stainless Steel (CrNi) | Rate of Canine Retraction Per Month | 1.42 mm/month |