A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Baghdad
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Primary outcome (Alignment efficiency)
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Blinding to treatment allocation was possible only for the investigator and data analyst because the clinicians could know the type of archwiers from their flexibility. All the trial documents were labeled with the study ID number, which was used for participant identification and data collection without unmasking the allocation group. This allowed the investigator to complete data collection and measurements blindly.
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Heat-Activated Nickel-Titanium Archwires
Heat-activated NiTi (HANT) Group (TruFlex™ Thermal Nickel-Titanium, Ortho Technology, USA):
- 0.014-inch HANT
- 0.016-inch HANT
Intervention: Orthodontic treatment (Procedure)
Superelastic Nickel-Titanium Archwires
Superelastic NiTi (SENT) Group (TruFlex™ Nickel-Titanium, Ortho Technology, USA):
- 0.014-inch SENT
- 0.016-inch SENT
Intervention: Orthodontic treatment (Procedure)
Outcomes
Primary Outcomes
Primary outcome (Alignment efficiency)
Time Frame: 2 months
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).
Secondary Outcomes
- Pain perception(2 months)
- Root resorption(2 months)
Investigators
Yassir A. Yassir
Assistant Professor of Orthodontics
University of Baghdad