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

NCT04090931 | Completed DMC

• 1 other identifier: University of Baghdad
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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. 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. 2.To compare the amount of pain perception between the two groups of archwires during the 1st week after each wire placement.

Conditions

Teeth; Anomaly, Position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Root resorption

  2 months

• Pain perception

  2 months

Study Arms (2)

Heat-Activated Nickel-Titanium Archwires

EXPERIMENTAL

Heat-activated NiTi (HANT) Group (TruFlex™ Thermal Nickel-Titanium, Ortho Technology, USA): * 0.014-inch HANT * 0.016-inch HANT

Procedure: Orthodontic treatment

Superelastic Nickel-Titanium Archwires

EXPERIMENTAL

Superelastic NiTi (SENT) Group (TruFlex™ Nickel-Titanium, Ortho Technology, USA): * 0.014-inch SENT * 0.016-inch SENT

Procedure: Orthodontic treatment

Interventions

Orthodontic treatment PROCEDURE

leveling and aligning stage in orthodontics

Heat-Activated Nickel-Titanium Archwires; Superelastic Nickel-Titanium Archwires

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Yassir A. Yassir

Baghdad, 00964, Iraq

Location

Related Publications (1)

• Nabbat SA, Yassir YA. A clinical comparison of the effectiveness of two types of orthodontic aligning archwire materials: a multicentre randomized clinical trial. Eur J Orthod. 2020 Dec 2;42(6):626-634. doi: 10.1093/ejo/cjz102.

  PMID: 32011678 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthodontics

Model Details: Orthodontic patients

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 16, 2019
• Study Start: January 3, 2019
• Primary Completion: April 26, 2019
• Study Completion: September 9, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)