Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires

Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires. A Randomized Control Trial

To compare the alignment efficiency of conventional NiTi arch wire to Thermal and Super elastic NiTi arch wires.

Study Overview

• Status: Enrolling by invitation
• Conditions: Crowding of Anterior Mandibular Teeth
• Intervention / Treatment: Procedure: orthodontic treatment with fixed appliances

Detailed Description

Method: All the participants will be recruited from Ziauddin University dental OPD, each will be provided with full information about study. An informed consent form will be signed from every patient or their guardian/parents. Patients who agree to be part of this study will be included.

Subjects will be treated by Orthodontic resident under faculty supervision. Pre-treatment mandibular crowding will be assessed on dental casts. Randomization of the three groups will be done by "Opaque envelope technique" Bonding will be done using 3M uniteck brackets. After initial bonding good quality mandibular impressions will be taken and poured to obtain dental casts. Impressions and casts will be obtained at every 4 weeks interval until the initial alignment phase is complete. At the time of bonding all lower anterior teeth will be fully engaged in the archwire. The principal researcher will tag every model with an identification code before calculating measurements.

The contact point displacements will be measured with vernier caliper using the Little's index of irregularity. All measurements will be then summed and aggregated value will represent the degree of anterior irregularities.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75000
      • Ziauddin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• lower anterior crowding good oral hygeine all permanent lower incisors no previous orthodontic treatment

Exclusion Criteria:

• extracted or missing lower incisors poor oral hygeine relevant medical history previous orthodontic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: conventional niti arch wire group; all participants in this group will be placed conventional 014 niti lower archwire.	Procedure: orthodontic treatment with fixed appliances; comprehensive orthodontic treatment with fixed orthodontic appliances for the correction of misaligned teeth.
Other: super elastic niti archwire group; all participants will be given super elastic 014 lower NiTi archwire.	Procedure: orthodontic treatment with fixed appliances; comprehensive orthodontic treatment with fixed orthodontic appliances for the correction of misaligned teeth.
Other: thermal niti archwire group; all participants will be given thermal lower 014 niti archwire.	Procedure: orthodontic treatment with fixed appliances; comprehensive orthodontic treatment with fixed orthodontic appliances for the correction of misaligned teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing the alignment efficiency of three types of NiTi archwires.	alignment of lower anterior crowding	4 months

Collaborators and Investigators

• Sponsor: Ziauddin University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Alignment; Crowding; Nitinol; Nickel Titanium; Archwires
• Other Study ID Numbers: 1431019DSAOM

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