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Completed

NCT Number: NCT07176871

Comparing HANT and Conventional NiTi Archwires in Alignment

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.

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Key information

Conditions

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho University of Medicine and Pharmacy

Can Tho, 90000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Archwires

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Tooth root length

    Time frame: Baseline (T0), After 6 months (T6)

    The change of tooth root length after 6 months

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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