UnknownNot Applicable

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

Colombia54 participantsStarted 2017-07-08

Plain-language 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.

Who can participate

Age range

13 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quantity of anterior mandibular crowding resolution

Timeframe: baseline and three months

Trial details

NCT IDNCT03256279

SponsorFundación Universitaria CIEO

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-10

Contact for this trial

Suly Amaya, DDS

315 783 72 45 sulyamgo@yahoo.es

View on ClinicalTrials.gov More Crowding of Anterior Mandibular Teeth trials