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

Dental Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387578
• Other study ID #: 103
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 20, 2019

Study information

• Verified date: May 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Crowding
• Dental Malocclusion
• Malocclusion

Intervention

Device:
• fixed orthodontic appliance and arch wires
leveling and aligning stages in orthodontics

Locations

Country	Name	City	State
Egypt	Al Azhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Talaat Hussein Ali

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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