A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effectiveness of using heat-activated NiTi with superelastic NiTi archwires during the initial phase of orthodontic treatment. Primary Objective: To compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks from the start of treatment. Secondary Objectives: To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular central incisors between the two groups of archwires To compare the amount of pain perception between the two groups of archwires during the 1st week after each wire placement.

Detailed Description
-----------------
Objectives: To compare the heat-activated nickel titanium (HANT) with superelastic nickel titanium (SENT) archwires in terms of their effectiveness in aligning teeth, possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment. Subjects and Methods: Orthodontic patient aged 12 years or over with lower anterior crowding of 3-6 mm. who need treatment without extraction, were randomly allocated to the HANT and SENT archwires groups with a 1:1 allocation ratio. Archwire sequence in both groups was 0.014-inch and 0.016-inch, respectively. Each archwire was placed for 4 weeks. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment was tested using 2X2 mixed factorial ANOVA, while root resorption and pain perception were tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P<0.05).

Official Title
-----------------
A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials: A Randomized Clinical Trial

Conditions
-----------------
Teeth; Anomaly, Position

Intervention / Treatment
-----------------
* Procedure: Orthodontic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the Little's irregularity index (LII). Full set of lower permanent dentition excluding the third molars. No history of trauma or root resorption in the lower incisors. Exclusion Criteria: Previous orthodontic treatment. Less than 3mm of lower incisor crowding (LII) or with spaced incisors. Severe crowding in the lower arch (greater than 7mm) which requires extraction. Blocked-out teeth that cannot be engaged with the aligning archwire. Patients with periodontally compromised teeth.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Orthodontic patients
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heat-Activated Nickel-Titanium Archwires<br>Heat-activated NiTi (HANT) Group (TruFlex™ Thermal Nickel-Titanium, Ortho Technology, USA): 0.014-inch HANT 0.016-inch HANT | Procedure: Orthodontic treatment<br>* leveling and aligning stage in orthodontics<br>|
| Experimental: Superelastic Nickel-Titanium Archwires<br>Superelastic NiTi (SENT) Group (TruFlex™ Nickel-Titanium, Ortho Technology, USA): 0.014-inch SENT 0.016-inch SENT | Procedure: Orthodontic treatment<br>* leveling and aligning stage in orthodontics<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome (Alignment efficiency) | The study models, which should be free from any inconsistency (such as bubbles), were used to measure the Little's irregularity index (Little, 1975). This was calculated using a digital Vernier caliper to measure the extent of mesial and distal contact displacement from the mesial contact point of lower canine to that on the other side (to the nearest 0.01mm). | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root resorption | Root resorption was evaluated pre-treatment and after 8 weeks using periapical X-ray with digital X-ray sensors (ATECO). Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds. | 2 months | 
| Pain perception | Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10-point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to no pain and 10 refers to intolerable pain. Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment. | 2 months |