Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires

Study Overview
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Brief Summary
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This study will be done to compare the effectiveness of using coaxial tubular superelastic nickel-titanium and copper-nickel-titanium archwires during the initial phase of orthodontic treatment regarding alignment efficiency, pain perception, and root resorption.

Detailed Description
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This will be a prospective blinded non-stratified randomized clinical trial , parallel group trial with equal randomization (1:1 allocation ratio), different private clinics and general hospitals will allocate patients for this trial. The patients will be initially assessed for eligibility to be included in the study by the investigator. Those who will meet the inclusion criteria will be informed about the nature of the study verbally to take the initial approval for participation. The patients were asked to read the patient information sheet carefully at home and inform the investigator about their decision of participation at the subsequent appointment and to sign consent form sheet in case of agreement. The patients will be treated using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying All the participants will receive the same treatment. At the day of bonding, the first archwire will be placed for each group. Eight weeks later it will be replaced by the next size archwire for another eight weeks. Archwires will be tied to the bracket using elastomeric ligatures. Any debonding during treatment should be considered an emergency and re-bonded within 24 hours, otherwise the case will be dropout. A good alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be given visual analog scale to record their pain p during the first week after each archwire placement.

Official Title
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Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires: A Randomized Clinical Trial

Conditions
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Aligning Archwires

Intervention / Treatment
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* Other: aligning archwires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients indicated for fixed appliance orthodontic treatment with 5-9 mm crowding of mandibular anterior teeth according to Little's irregularity index (LII). Presence of all the mandibular permanent teeth, except the third molars. Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth. No history of trauma or root resorption in the mandibular incisors. Exclusion Criteria: Previous orthodontic treatment. Less than 5 mm of mandibular incisors crowding (LII). Severe crowding which requires treatment by extraction of premolars in the mandibular arch. Blocked-out teeth that cannot be engaged with the aligning archwire. Prior experience of periodontal disease and loss of attachment.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be treated with straight wire appliance using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying Archwire sequence for each group will be as follows: Coaxial tubular superelastic nickel-titanium Group (TuNT) (Speed tubular supercable, Speed System™ Orthodontics, Ontario, Canada): 0.016-inch 0.018-inch Copper-nickel-titanium Group (CuNT) (Damon Optimal-Force Copper Ni-Ti®, Ormco, Glendora, Calif): 0.014-inch 0.018-inch Allocation Concealment: This will be achieved using sequentially numbered, opaque and sealed envelopes which will be numbered according to the study numbers. Each envelope includes the treatment allocation card (group 1 or 2) and the related archwires.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaxial tubular superelastic nickel-titanium Group (TuNT)<br>0.016-inch coaxial tubular superelastic nickel-titanium archwire (TuNT) (Speed tubular supercable, Speed System™ Orthodontics, Ontario, Canada) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks | Other: aligning archwires<br>* At the day of bonding, 0.016-inch archwire will be placed for the TuNT group. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. While, for the CuNT group, 0.014-inch archwire will be placed at the day of bonding and eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Archwires will be tied to the bracket by elastomeric modules which will be changed every 4 weeks. A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be provided by a visual analog scale (0-10) to record their pain perception during the first week after each wire placement.<br>|
| Experimental: Copper-nickel-titanium Group (CuNT)<br>0.014-inch Copper-nickel-titanium archwire (CuNT) (Damon Optimal-Force Copper Ni-Ti®, Ormco, Glendora, Calif) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. | Other: aligning archwires<br>* At the day of bonding, 0.016-inch archwire will be placed for the TuNT group. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. While, for the CuNT group, 0.014-inch archwire will be placed at the day of bonding and eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Archwires will be tied to the bracket by elastomeric modules which will be changed every 4 weeks. A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be provided by a visual analog scale (0-10) to record their pain perception during the first week after each wire placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in alignment of anterior teeth will be measured using Little's irregularity index | A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. This study model which should be free from any discrepancy (such as bubbles) will be used to measure Little's irregularity index using a digital Vernier caliper to calculate the amount of mesial and distal contact displacement from the mesial contact surface of right mandibular canine to that on the other side, to the nearest 0.01 mm. The sum of these measurements represents the amount of Little's irregularity index. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root resorption using the scoring index that was provided by Malmgren et al. (1982) | Root resorption will be evaluated for the mandibular central incisors using periapical radiographs with digital sensors, and the worst score for either left or right central will be taken using the scoring index by Malmgren et al. (1982): Grade 1: Irregular apical root contour. Grade 2: Minor apical root resorption, a small area of root loss amounting to less than 2 mm. Grade 3: Severe apical root resorption from 2 mm to one third of the original root length. Grade 4: Extreme apical root resorption exceeding one third of the original root length. | 16 weeks | 
| pain perception using visual analog scale | Evaluations of pain/discomfort will be made in the evening on a daily basis over the first seven days after bonding using a 10-point visual analog scale (VAS) with 0 refers to no pain and 10 refers to intolerable pain. The participants will be reminded daily by a phone call or a text message to mark the recording sheet and will be asked to bring it on their next appointment. | 1st week after each wire placement. |