- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07176871
- Original Trial
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
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
Interventional
Enrollment (Actual)
52
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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)
|
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).
|
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
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
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.
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)
July 1, 2024
Primary Completion (Actual)
July 1, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
August 30, 2025
First Submitted That Met QC Criteria
September 12, 2025
First Posted (Estimated)
September 16, 2025
Study Record Updates
Last Update Posted (Estimated)
September 16, 2025
Last Update Submitted That Met QC Criteria
September 12, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID 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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