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Dental Arch Relationship AnomalyNCT04043013

Influence of Four Orthodontic Bracket Prescriptions in Arch Width and Torque

A study testing Mini-Taurus® (Rocky Mountain©) Brackets, Smart Clip® SL3 High Torque (3M Unitek©) and Tip-Edge Plus® (TP Orthodontics©) in people with Dental Arch Relationship Anomaly, run by University of Valencia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study compares torque and arch width changes between four different orthodontic bracket prescriptions and determine whether changes in dental torque are correlated to changes in arch width at the end of orthodontic treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Dental Arch Relationship Anomaly
What is being tested?
Mini-Taurus® (Rocky Mountain©) Brackets, Smart Clip® SL3 High Torque (3M Unitek©) and Tip-Edge Plus® (TP Orthodontics©)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
No sites listed yet
Study dates
1 May 2015to 30 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of permanent dentition from the first permanent molar, from one side to the other.
  • Absence of anomalies in number, size and dental shape
  • No pre-treatment transversal discrepancies
  • Equivalency in pre-treatment vertical relationships
  • Good quality of study models
  • No medical contra-indications to the use of fixed appliances
  • Good standard of oral hygiene

Who cannot join

  • Presence of oral habits
  • Need to use of two band expansive appliances through the treatment
  • Need of an orthodontic treatment with extractions
  • Requiring orthognathic surgery as a part of their treatment

About this study

Official title: Influence of Four Different Orthodontic Bracket Prescriptions in Total Posterior Arch Width and Torque Expression

The study compares torque and arch width changes between four different orthodontic bracket prescriptions and determine whether changes in dental torque are correlated to changes in arch width at the end of orthodontic treatment.

From an initial sample of 250 patients who sought treatment at the Department of Orthodontics (University of Valencia, Spain), a subsample of 76 patients (31 men and 45 women) were selected to meet inclusion criteria.

Read more

The sample was randomly allocated into four groups according to four different orthodontic bracket prescriptions: Prescription A (n=22): Mini-Taurus® (Rocky Mountain©); Prescription B (n=17): Smart Clip® SL3 High Torque (3M Unitek©); Prescription C (n=18): Tip-Edge Plus® (TP Orthodontics©); Prescription D (n=19): Victory® (3M Unitek©).

Initial (T0) and final (T1) plaster and digital study models were available for all patients. Measurements were taken from frontal and occlusal images of the models by a single experienced operator.

Read the detailed description

Subjects Seventy-six patients (31 men and 45 women) were recruited to participate in the clinical study and who fulfilled the inclusion and exclusion criteria. The inclusion criteria were: Presence of permanent dentition from the first permanent molar, from one side to the other, absence of anomalies in number, size and dental shape, no pre-treatment transversal discrepancies, equivalency in pre-treatment vertical relationships, good quality of study models, no medical contra-indications to the use of fixed appliances and good standard of oral hygiene.

The exclusion criteria were: Presence of oral habits. need to use of two band expansive appliances through the treatment, need of an orthodontic treatment with extractions or requiring orthognathic surgery as a part of their treatment. Subject age and gender were not taken as exclusion criteria, as these variables were not expected to influence the research outcomes.

Sample size calculation A pre-study sample size calculation was performed; power analysis showed that a sample size of at least 64 patients would provide an 80% probability of detecting a medium effect (f=0.2) associated with the interaction term, using an ANOVA model at a confidence level of 95% and assuming a correlation among repeated measurements of 0.5.

Study design: Orthodontic prescription techniques Subjects were chosen randomly and prospectively. Using sealed envelopes with the letters A to D, which corresponded to the 4 treatment groups, patients were parallelly randomly allocated according to the orthodontic bracket prescription of each particular technique so that patients each received either Prescription A (n=22): Mini-Taurus (Rocky Mountain); Prescription B (n=17): Smart Clip SL3 High Torque (3M Unitek); Prescription C (n=18): Tip-Edge Plus (TP Orthodontics); and Prescription D (n=19): Victory (3M Unitek). All underwent standard orthodontic treatments with good occlusal results.

Blinding Once the patient had been randomly allocated to one group or another, it was not possible to blind either the patient or the operator to the bracket type.

Settings All brackets had 0.22 inch slots. Since arch width is directly related to archwire form, the same arch form was used for all 4 techniques: Ovoid Arch FormOrthoForm III (3M Unitek). All patients followed the same archwire sequence starting with a 0.012 SE NiTi (superelastic niquel titanium) archwire, followed by a 0.016 SE NiTi, 0.016 x 0.025 SE NiTi and a 0.019 x 0.025 SE NiTi. The last wire used was a 0.019 x 0.025 inch stainless steel archwire. Two operators (C.G and N.Z) with the same background and experience treated the patients. The arch form was not modified during treatment by either expansion or contraction of the archwires. In all cases, stainless steel ligatures were used, except in technique C where the self-ligating system was applied.

Measurements Occlusal and frontal digital models corresponding to all subjects' upper arches were taken from the initial and final plaster study models. Models were digitalized using the iTero Element digital scanning system. All the models were digitalized by the same operator under identical light conditions.

All measurements were carried out by the same operator (B.T) using the Orthocad software. The operator registered the measurements as T0 (pre-treatment values) and T1 (post-treatment values).

Occlusal images were used to measure intercanine, interpremolar and intermolar widths (mm) from initial (T0) and final (T1) study models. A specific protocol was used to take the following interarch width measurements before and after treatment:

Intercanine width: distance between the cusp tips of bilateral canines. First interpremolar width: distance between the vestibular cusp tips of first bilateral premolars.

Second interpremolar width: distance between the vestibular cusp tips of second bilateral premolars.

Intermolar width: distance between mesiovestibular cusps of first bilateral molars.

Frontal images were used for measuring torque (º) of bilateral canines, first premolars, second premolars, and molars from initial (T0) and final (T1) study models. The torque of maxillary arches was measured before (T0) and after (T1) treatment.

Measurements were taken on the basis of:

Reference lines: two reference lines were established.

  1. Horizontal line: line passing through the mesiovestibular cusps of right and left first superior molars.
  2. Vertical line: perpendicular to the former line, passing through the centre of the papilla between the two superior central incisors.

Crown axis lines: parallel lines to the vestibular contour of the crowns of canines, premolars and molars, running from the vestibular cusp to the highest point of the gingival margin visible from the frontal projection.

Torque measurements: The angle between the vertical line and the crown axis line of each tooth. Torque was measured and given a positive, negative or 0º value. Positive or negative values were assigned based on the clockwise or counterclockwise divergence of the lines, whereas a 0º value was assigned when they were parallel.

Depending on the torque values at T0, variations in torque at T1 were classified as follows:

Negative torque value: when higher negative values were measured at T0 than T1 (e.g. -5º at T0 and -2º at T1).

Positive torque value: when higher positive values were measured at T0 than T1 (e.g. 5º at T0 and 2º at T1).

Being tested
Mini-Taurus® (Rocky Mountain©) Brackets, Smart Clip® SL3 High Torque (3M Unitek©), Tip-Edge Plus® (TP Orthodontics©), Victory® (3M Unitek©)
Keywords
ARCH, TORQUE, BRACKET, PRESCRIPTION

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mini-Taurus® (Rocky Mountain©) BracketsDevice

  • Smart Clip® SL3 High Torque (3M Unitek©)Device

  • Tip-Edge Plus® (TP Orthodontics©)Device

  • Victory® (3M Unitek©)Device

Study groups in NCT04043013
Study groupRoleWhat they receive
Mini-Taurus® (Rocky Mountain©) BracketsActive comparatorBrackets Mini-Taurus® (Rocky Mountain©) with: ORTHODONTIC BRACKET PRESCRIPTION Canines 0º First Premolar 0º Second Premolar 0º First Molar 0º
Receives: Device: Smart Clip® SL3 High Torque (3M Unitek©); Device: Tip-Edge Plus® (TP Orthodontics©); Device: Victory® (3M Unitek©)
Smart Clip® SL3 High Torque (3M Unitek©)Active comparatorBrackets Smart Clip® SL3 High Torque (3M Unitek©) with: ORTHODONTIC BRACKET PRESCRIPTION Canines +6º First Premolar -4º Second Premolar -4º First Molar -14º
Receives: Device: Mini-Taurus® (Rocky Mountain©) Brackets; Device: Tip-Edge Plus® (TP Orthodontics©); Device: Victory® (3M Unitek©)
Tip-Edge Plus® (TP Orthodontics©)Active comparatorBrackets Tip-Edge Plus® (TP Orthodontics©) with: ORTHODONTIC BRACKET PRESCRIPTION Canines -4º First Premolar -7º Second Premolar -7º First Molar 0º -14º -11º -14º
Receives: Device: Mini-Taurus® (Rocky Mountain©) Brackets; Device: Smart Clip® SL3 High Torque (3M Unitek©); Device: Victory® (3M Unitek©)
Victory® (3M Unitek©)Active comparatorBrackets Victory® (3M Unitek©) with: ORTHODONTIC BRACKET PRESCRIPTION Canines 0º First Premolar -7º Second Premolar -7º First Molar -14º
Receives: Device: Mini-Taurus® (Rocky Mountain©) Brackets; Device: Smart Clip® SL3 High Torque (3M Unitek©); Device: Tip-Edge Plus® (TP Orthodontics©)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of posterior torque from the initial occlusion to the final occlusion at the end of the orthodontic treatment.

    Degrees

    Measured: Measurement 1: At the begining of orthodontic treatment. Measurement 2: through orthodontic treatment completion, an average of 18 months

  2. Change of arch width from the initial occlusion to the final occlusion at the

    Millimeters

    Measured: Measurement 1: At the beginning of orthodontic treatment. Measurement 2: through orthodontic treatment completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start1 May 2015
  3. Primary completion30 Oct 2016
  4. Study completion30 Apr 2017

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043013
Sponsor's protocol ID
H1337808714794
Status last verified
Oct 2019
First submitted
10 Jul 2019
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mini-Taurus® (Rocky Mountain©) Brackets, Smart Clip® SL3 High Torque (3M Unitek©) and Tip-Edge Plus® (TP Orthodontics©) in people with Dental Arch Relationship Anomaly, run by University of Valencia.

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 7 inclusion and 4 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 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change of posterior torque from the initial occlusion to the final occlusion at the end of the orthodontic treatment. (time frame: Measurement 1: At the begining of orthodontic treatment. Measurement 2: through orthodontic treatment completion, an average of 18 months). The study lists 2 primary outcomes in all. 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 24 Oct 2019.

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