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

Not Applicable

Completed

• Conditions: Dental Crowding; Dental Malocclusion
• Interventions: Device: fixed orthodontic appliance and arch wires

• Registration Number: NCT04387578
• Lead Sponsor: Ahmed Talaat Hussein Ali

Brief Summary

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

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 Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B Gummetal arch wires	fixed orthodontic appliance and 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.
Group A singlestrand NiTi arch wires	fixed orthodontic appliance and 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.
Group C multistrand NiTi arch wires	fixed orthodontic appliance and 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.	three months of leveling and alignment	evaluation 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	comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.

Trial Locations

Locations (1)

Al Azhar university; 🇪🇬 Cairo, Egypt