Comparing HANT and Conventional NiTi Archwires in Alignment

September 12, 2025 updated by: Can Tho University of Medicine and Pharmacy

Comparing the Alignment Effectiveness of Heat-activated Nickel-titanium (HANT) Versus Conventional Sequences Nickel-titanium (NiTi) Archwires: A Randomized Clinical Trial

This randomized clinical trial evaluated the efficiency of two orthodontic archwire sequences for correcting maxillary anterior crowding. Forty extraction patients (Little's irregularity index: 7-9 mm) were randomly assigned to either a sequence incorporating heat-activated nickel-titanium (HANT) archwires or a conventional NiTi sequence. Digital scans at baseline and monthly intervals up to 6 months assessed alignment changes, while CBCT measured root length and alveolar bone alterations. Pain intensity was recorded using a visual analog scale at 24 hours, 3 days, and 1 week after archwire placement. Statistical significance was set at p ≤ 0.05.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: To compare the clinical efficiency of two sequences of orthodontic wires to correct crowding of the maxillary anterior teeth, one using conventional nickel-titanium (NiTi) archwires and the other utilizing nickel-titanium (NiTi) combined heat-activated nickel-titanium (HANT) archwires in terms of alignment effectiveness, tooth root length, alveolar bone changes, and pain intensity. Methods: Forty patients requiring fixed orthodontic treatment with Little's irregularity index of 7 to 9 mm, who needed first premolar extractions, were recruited. A lottery was conducted for the patients, assigning odd numbers to use HANT archwires (0.014 NiTi, 0.019x0.025 HANT, and 0.019x0.025 SS). (Group 1), and even numbers to use conventional NiTi archwire sequences (0.014 NiTi, 0.016 NiTi, 0.016x0.022 NiTi, 0.019x0.025 NiTi, and 0.019x0.025 SS) (Group 2). Digital scans were taken of the maxilla arch before archwire placement (T0) and at each month (30 days) follow-up leading up to the 6th month (T6). The rate of tooth alignment was measured on digital dental casts by determining Little's irregularity index. The pain experienced by the patient was evaluated 24 hours, 3 days, and 1 week following the placement of the archwire, using a visual analog scale (VAS). Cone beam computed tomographic (CBCT) radiographs of the maxillary anterior teeth were taken before and after alignment to evaluate changes in tooth root length and alveolar bone. Statistical analysis was performed using SPSS software (version 18.0), with significance at p ≤ 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Can Tho, Vietnam, 90000
        • Can Tho University of Medicine and Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with Class I malocclusion on both sides
  • aged between 16 and 25 years with permanent dentition
  • bilateral extraction of the maxillary first premolar
  • maxillary Little's irregularity index between 7-9 mm
  • patients with no periodontal disease.

Exclusion Criteria:

  • Patients who had previous orthodontic treatment,
  • spacing in the maxillary anterior region
  • suffer from bleeding disorders, diabetes, bone diseases, periodontal disease, and cancer, as well as those using drugs (such as aspirin, heparin, warfarin, nonsteroidal anti-inflammatory drugs, and glucocorticoids)
  • Patients with trauma and facial deformities, smokers, or pregnant were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Conventional NiTi AWs
even numbers to use conventional NiTi archwire sequences (0.014 NiTi, 0.016 NiTi, 0.016x0.022 NiTi, 0.019x0.025 NiTi, and 0.019x0.025 SS)
Procedure: Archwires
All patients were treated with 0.022-inch MBT brackets and sequential NiTi/HANT archwires. A 0.014 NiTi wire was placed initially, followed by monthly archwire changes if no deflection remained. Digital scans were taken from baseline (T0) to 6 months (T6) to measure alignment using Little's irregularity index. Pain was recorded at 24 hours, 3 days, and 1 week with a visual analog scale. CBCT scans before and after alignment assessed root length and alveolar bone changes, with standardized 3D superimpositions ensuring accurate comparisons.
Experimental: HANT Aw
odd numbers to use HANT arch wires (0.014 NiTi, 0.019x0.025 HANT, and 0.019x0.025 SS).
Procedure: Archwires
All patients were treated with 0.022-inch MBT brackets and sequential NiTi/HANT archwires. A 0.014 NiTi wire was placed initially, followed by monthly archwire changes if no deflection remained. Digital scans were taken from baseline (T0) to 6 months (T6) to measure alignment using Little's irregularity index. Pain was recorded at 24 hours, 3 days, and 1 week with a visual analog scale. CBCT scans before and after alignment assessed root length and alveolar bone changes, with standardized 3D superimpositions ensuring accurate comparisons.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alignment effectiveness
Time Frame: Baseline (T0) and at each month (30 days) follow-up leading up to the 6th month (T6).
The rate of tooth alignment was measured on digital dental casts by determining Little's irregularity index
Baseline (T0) and at each month (30 days) follow-up leading up to the 6th month (T6).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tooth root length
Time Frame: Baseline (T0), After 6 months (T6)
The change of tooth root length after 6 months
Baseline (T0), After 6 months (T6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Can Tho University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FOS CTUMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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