Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling

Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling: A Prospective Clinical Study

The present prospective clinical study was directed to evaluate the efficiency of three different aligning archwires during initial orthodontic leveling.

Study Overview

• Status: Completed
• Conditions: Dental Malocclusion; Dental Crowding
• Intervention / Treatment: Device: fixed orthodontic appliance and arch wires

Detailed Description

The present prospective clinical study was directed to evaluate efficiency of three different aligning arch wires during initial orthodontic leveling.

The sample of present study included 30 patients, 15 females and 15 males; with a mean age was 17.81 ± 1.96 years. They were randomly allocated into three equal groups, according to the type of the aligning arch wire as follows:

1. Group A: in which 10 patients, with a mean age was 17.27 ± 1.95 years, were treated with conventional singlestrand NiTi arch wires.
2. Group B: in which 10 patients, with a mean age was 17.33 ± 2.42 years, were treated with Niobium-titanium-tantalum-Zirconium (Gummetal) arch wires.
3. Group C: in which 10 patients, with a mean age was 18.70 ± 1.49 years, were treated with multistrand NiTi arch wires.

Mandibular orthodontic study models were taken every 4 weeks and laser scanned to obtain 3D digital models during the 3 months observation period of the study. The changes in LII were determined at every 4 weeks observation intervals. Moreover, the changes in inter-canine, inter-1st premolar and inter-molar widths before and after three months were evaluated and compared among the three groups of aligning arch wires.

Data were collected and statistically analyzed via Statistical Package for Social Science (SPSS, version 23). One Way ANOVA and Kruskall-Wallis tests were used to assess the difference among the three studied groups and paired t-test was used to assess the difference and percent of changes within each group before and after three months observation period.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• An age range from 15 to 20 years
• All permanent teeth have erupted (3rd molar not included)
• Angle class I malocclusion with normal facial proportions.
• Moderate crowding in the lower dental arch that required treatment with fixed appliance using the non-extraction approach.
• Good oral hygiene with healthy periodontium, good general health without any systematic disease that could affect the treatment.

Exclusion Criteria:

• Severe crowding that requires an extraction approach.
• A blocked-out tooth that prevent the easy placement of the bracket at the initial bonding appointment.
• Poor oral hygiene or periodontal compromised teeth.
• Relevant medical history and/or regular medication that contraindicates and/or interferes with orthodontic treatment.
• Craniofacial anomalies or previous history of trauma, bruxism, or parafunction.
• Previous orthodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A singlestrand NiTi arch wires; in which 10 patients (5 males and 5 females) were treated with round singlestrand NiTi arch wires in a sequence of 0.012, 0.014, and 0.016 inch.	Device: fixed orthodontic appliance and arch wires; leveling and aligning stages in orthodontics
EXPERIMENTAL: Group B Gummetal arch wires; in which 10patients (6 males and 4 females) were treated with niobium-titanium-tantalum-Zirconium arch wires (Gummetal arch wires) in a sequence of 0.014, 0.016, and 0.018 inch.	Device: fixed orthodontic appliance and arch wires; leveling and aligning stages in orthodontics
EXPERIMENTAL: Group C multistrand NiTi arch wires; in which 10 patients (4males and 6females) were treated with multistrand NiTi arch wires in a sequence of 0.016, 0.018, and 0.020 inch.	Device: fixed orthodontic appliance and arch wires; leveling and aligning stages in orthodontics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of the alignment efficiency	evaluation of the alignment efficiency among the three investigated arch wires via the measurement of the scores of Little's Irregularity Index	three months of leveling and alignment
comparison of the alignment efficiency	comparison of the alignment efficiency among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index	three months of leveling and alignment
evaluation of the alignment rate	evaluation of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index	three months of leveling and alignment
comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index	comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index	three months of leveling and alignment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.	evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.	three months of leveling and alignment
comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.	comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.	three months of leveling and alignment

Collaborators and Investigators

• Sponsor: Ahmed Talaat Hussein Ali
• Investigators: Principal Investigator: Ahmed T Ali, Demonstrator, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): September 10, 2019
• Study Completion (ACTUAL): September 20, 2019

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (ACTUAL): May 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: alignment; Orthodontic arch wire; Gummetal arch wire; multistrand arch wire
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No