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

Primary Purpose

Dental Malocclusion, Dental Crowding

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fixed orthodontic appliance and arch wires
Sponsored by
Ahmed Talaat Hussein Ali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Malocclusion focused on measuring Orthodontic arch wire, alignment, Gummetal arch wire, multistrand arch wire

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al Azhar university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A singlestrand NiTi arch wires

Group B Gummetal arch wires

Group C multistrand NiTi arch wires

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 5, 2020
Last Updated
May 12, 2020
Sponsor
Ahmed Talaat Hussein Ali
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1. Study Identification

Unique Protocol Identification Number
NCT04387578
Brief Title
Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling
Official Title
Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling: A Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Talaat Hussein Ali

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Group A: in which 10 patients, with a mean age was 17.27 ± 1.95 years, were treated with conventional singlestrand NiTi arch wires. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion, Dental Crowding
Keywords
Orthodontic arch wire, alignment, Gummetal arch wire, multistrand arch wire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A singlestrand NiTi arch wires
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B Gummetal arch wires
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C multistrand NiTi arch wires
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
fixed orthodontic appliance and arch wires
Intervention Description
leveling and aligning stages in orthodontics
Primary Outcome Measure Information:
Title
evaluation of the alignment efficiency
Description
evaluation of the alignment efficiency among the three investigated arch wires via the measurement of the scores of Little's Irregularity Index
Time Frame
three months of leveling and alignment
Title
comparison of the alignment efficiency
Description
comparison of the alignment efficiency among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Time Frame
three months of leveling and alignment
Title
evaluation of the alignment rate
Description
evaluation of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Time Frame
three months of leveling and alignment
Title
comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Description
comparison of the alignment rate among the three investigated arch wiresvia the measurement of the scores of Little's Irregularity Index
Time Frame
three months of leveling and alignment
Secondary Outcome Measure Information:
Title
evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Description
evaluation of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Time Frame
three months of leveling and alignment
Title
comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Description
comparison of the transverse mandibular arch dimensions changes among the three investigated arch wires.
Time Frame
three months of leveling and alignment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed T Ali, Demonstrator
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Azhar university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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