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Clinical Trials/NCT04090931
NCT04090931
Completed
Not Applicable

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

University of Baghdad1 site in 1 country31 target enrollmentJanuary 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Teeth; Anomaly, Position
Sponsor
University of Baghdad
Enrollment
31
Locations
1
Primary Endpoint
Primary outcome (Alignment efficiency)
Status
Completed
Last Updated
6 years ago

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:

  1. 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
  2. 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).

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
September 9, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yassir A. Yassir

Assistant Professor of Orthodontics

University of Baghdad

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.

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)

Study Sites (1)

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