Mechanical Properties and Clinical Efficacy of Two Nickel-Titanium (NiTi) Archwires

NCT03256279 | Unknown

• 1 other identifier: UniCIEO
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: to compare the changes of the mechanical properties measured by tensile test and three point bending test of two NiTi archwires (heat-activated and superelastic); when exposed to the oral conditions during the first three months of orthodontic treatment and to evaluated their clinical efficacy in lower arch crowding resolution in the anterior mandibular arch. Methods: Randomized clinical trial in 54 orthodontic patients with moderate crowding. They are going to be randomly assigned in to two intervention groups, each group with 27 patients. One group are going to be treated with heat-activated NiTi archwires and the other group with superelastic NiTi archwires. The patients are going to be followed up for three months and cast models will be taken every month. Measures of anterior lower arch crowding resolution are going to be taken by previously-calibrated operators. Six archwires of each group will be chosen at random and will have tensile test and three-point bending test and the mechanical properties are going to measure before and after its clinical use. The outcomes are going to be determined and compared between groups, with correspondent statistical test and the results are going to be analyzed.

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

Orthodontic Wires; Alloys/therapeutic use; Orthodontics, corrective

Outcome Measures

Primary Outcomes (1)

• Quantity of anterior mandibular crowding resolution

  MBT prescription .022 slot. Alginate impressions and cast models at the beginning of the study, immediately after the first, second and third month of the orthodontic treatment. Measures of anterior lower arch crowding resolution are going to be taken by previously-calibrated operators.

  baseline and three months

Secondary Outcomes (2)

• Changes in Mechanical properties

  baseline and three months

• Archwire deformation

  baseline and three months

Study Arms (2)

Heat-activated archwire

EXPERIMENTAL

.014" NiTi heat-activated archwire in the lower arch during the first three months of the orthodonci treatment

Device: .014" NiTi heat-activated archwire

superelasticwire

ACTIVE COMPARATOR

This arm are going to receive .014" NiTi Superelastic archwire in the lower arch during the first three months of the orthodonci treatment

Device: .014" NiTi Superelastic archwire

Interventions

.014" NiTi heat-activated archwire DEVICE

.014" NiTi heat-activated archwire In the lower arch during the first three months of the orthodonci treatment

Heat-activated archwire

.014" NiTi Superelastic archwire DEVICE

.014" NiTi superelastic archwireIn the lower arch during the first three months of the orthodonci treatment

superelasticwire

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Orthodontic treatment without extraction with moderate anterior mandibular crowding (little index: 4-6mm)
• Age range between 15-25 years' old
• Non gingivitis or untreated caries at the start of orthodontic treatment
• Not need for intermaxillary elastics, striping, open compressed Nit springs, active labial arch, stainless ligature, during the first to the third months of orthodontic treatment
• Complete orthodontic appliances in the lower arch (at minimum from first molar to the first molar)

You may not qualify if:

• Patients with systemic disease
• Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti- inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
• Diseases that may affect dental movement
• Syndromic patients
• Patients with a history of trauma and/or root resorption at the lower arch
• Patients who do not attend more than one month to the appointment
• Lower .014" NiTi archwires that fracture during the first three months of the study.
• Patients with previous orthodontic treatment

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

Study Sites (1)

Orthodontic clinic of Post-graduation program UniCIEO

Bogotá, Bogotá D. C., 11011, Colombia

RECRUITING

Related Publications (1)

• Amaya Gonzalez SY, Roncancio AP, Acuna EA, Guevara Barreto LA, Vargas NM, Plaza-Ruiz SP. Alignment efficiency of heat activated and superelastic nickel-titanium archwires in orthodontic patients over three months: A Single-center, randomized clinical trial. J Orthod Sci. 2023 Mar 18;12:9. doi: 10.4103/jos.jos_19_22. eCollection 2023.

  PMID: 37351408 DERIVED

Study Officials

• Sonia Plaza, Ms.

  Fundación Universitaria CIEO

  STUDY DIRECTOR

Central Study Contacts

Suly Amaya, DDS

CONTACT

315 783 72 45; sulyamgo@yahoo.es

Humberto Guzman, DDS

CONTACT

315 3871090; tesisalambres@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only one of the investigators are going to know the archwire assigment, the other ones who are going to do the measures are going to be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher Orthodontic department

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: July 8, 2017
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)