Analysis of Orthodontic Tooth Movement Using 3D Imaging

NCT03398798 | Completed Results FDA Device

• 1 other identifier: 17-1446
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Purpose: This project aims to study the effects of wire dimension and ligation method (bracket type) on the first stage of orthodontic treatment using 3D imaging. Participants: Up to 80 patients at UNC School of Dentistry or Selden Orthodontics between the ages of 10 and 45, inclusive, who have been previously diagnosed with malocclusion requiring orthodontic treatment (braces) and are otherwise healthy. Procedures (methods): Subjects receiving standard of care (SOC) orthodontic treatment will be randomized to one of two commonly used orthodontic archwires (.014" or .016" diameter). Subjects will be further subdivided for analysis based on the type of bracket (twin or self-ligating) that their clinician uses in their treatment. We will review the 3D digital images of each subject's dentition recorded as part of SOC at the 0-, 6- and 12-week visits. We will retrieve the archwires when they are removed per SOC by the clinician at the 12-week time point.

Conditions

Tooth Crowding; Dental Crowding; Malocclusion

Keywords

archwire dimension; ligation method; bracket type

Outcome Measures

Primary Outcomes (2)

• Change in Little's Index From Baseline to 6 Weeks

  Little's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (0 weeks and 6 weeks).

  Baseline and 6 weeks

• Change in Little's Index From 6 Weeks to 12 Weeks

  Little's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (6 weeks and 12 weeks).

  6 weeks and 12 weeks

Secondary Outcomes (5)

• Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)

  Baseline and 6 weeks

• Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)

  6 weeks and 12 weeks

• Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)

  Baseline and 6 weeks

• Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)

  6 weeks and 12 weeks

• Correlation Between Degrees of Malalignment and Rate of Tooth Movement

  Baseline and 12 weeks

Study Arms (4)

.014" with twin brackets

ACTIVE COMPARATOR

.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.

Device: .014"; Device: Twin brackets

.016" with twin brackets

ACTIVE COMPARATOR

.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.

Device: .016"; Device: Twin brackets

.014" with self-ligating brackets

ACTIVE COMPARATOR

.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.

Device: .014"; Device: Self-ligating brackets

.016" with self-ligating brackets

ACTIVE COMPARATOR

.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.

Device: .016"; Device: Self-ligating brackets

Interventions

.014" DEVICE

.014" CuNiTi orthodontic arch wire

.014" with self-ligating brackets; .014" with twin brackets

.016" DEVICE

.016" CuNiTi orthodontic arch wire

.016" with self-ligating brackets; .016" with twin brackets

Twin brackets DEVICE

Ormco Insignia Metal Twin brackets

.014" with twin brackets; .016" with twin brackets

Self-ligating brackets DEVICE

Ormco Insignia SL brackets

.014" with self-ligating brackets; .016" with self-ligating brackets

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In the initial stage of active treatment at the University of North Carolina graduate orthodontic clinic or Selden Orthodontics
• Non-extraction treatment
• Maxillary and mandibular Little Index between 1-15 mm (this is a measurement of crowding)
• Presence of all permanent anterior teeth
• Age 10-45 years
• Consent to participate in the study

You may not qualify if:

• Systemic diseases such as diabetes, hypertension, temporomandibular disorders (TMD), craniofacial syndrome, etc.
• Any spacing between anterior teeth
• Subjects who have incisor mandibular plane angle (IMPA) greater than or equal to 100 degrees
• Anterior tooth completely blocked from the arch form
• Periodontal pocketing of any teeth greater than 4 mm
• Maxillary and mandibular Little Index \>15 mm (This is a measurement of crowding. A Little Index of \>15 mm indicates a need for a smaller dimension arch wire)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

UNC-CH School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Selden Orthodontics

Huntersville, North Carolina, 28078, United States

Location

MeSH Terms

Conditions

Malocclusion; Crowding

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Spatial Behavior; Behavior

Results Point of Contact

• Title: Christian Piers, DDS, MS, MFA
• Organization: University of North Carolina at Chapel Hill

christian.piers@gmail.com

(828) 433-1242

Study Officials

• Ching-Chang Ko, DDS, PhD

  UNC-CH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Neither subjects nor the treating orthodontists will know whether a .014" or 0.16" dimension wire is being used. The investigator will assign wire dimensions using a random number generator and distribute the wires to the treating orthodontists with the archwire dimension number removed from the package. The outcomes assessor will be blinded as to which patients were treated with which archwires while analyzing the digital models of the teeth. Because there is a clear visual difference between twin and self-ligating brackets, there will be no blinding with regard to ligation method (bracket type).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be four different groups in this study, with each planned to consist of 20 patients (40 dental arches). In the twin bracket cohort, 40 dental arches are planned to be treated with .014" dimension wire, and 40 dental arches are planned to be treated with .016" dimension wire. In the self-ligating bracket cohort, 40 dental arches are planned to be treated with .014" dimension wire, and 40 dental arches are planned to be treated with .016" dimension wire.

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 12, 2018
• Study Start: January 15, 2018
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)