Comparing HANT and Conventional NiTi Archwires in Alignment

NCT07176871 | Completed

• 1 other identifier: FOS CTUMP
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic

Outcome Measures

Primary Outcomes (1)

• Alignment effectiveness

  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 Outcomes (1)

• Tooth root length

  Baseline (T0), After 6 months (T6)

Study Arms (2)

Conventional NiTi AWs

EXPERIMENTAL

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

HANT Aw

EXPERIMENTAL

odd numbers to use HANT arch wires (0.014 NiTi, 0.019x0.025 HANT, and 0.019x0.025 SS).

Procedure: Archwires

Interventions

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.

Conventional NiTi AWs; HANT Aw

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, 90000, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 16, 2025
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)