Efficiency of Using Copper-Nickel-Titanium Versus Nickel-Titanium Arch Wires on Anterior Segment Crowding Alleviation in Group of Adults With Moderate Crowding

Efficiency of Using Copper-Nickel-Titanium Versus Nickel-Titanium Arch Wires on Anterior Segment Crowding Alleviation in Group of Adults With Moderate Crowding: A Randomized Controlled Clinical Trial

Evaluate the efficiency of using copper nickel titanium (CuNiTi) arch wire on the initial stage of leveling and alignment regarding their rate of alignment in comparison to Conventional Nickel Titanium arch wire (NiTi) by Measuring the amount and rate of alignment achieved every 2 weeks for a period of 2 months.

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Study Overview

• Status: Recruiting
• Conditions: Crowding of Anterior Mandibular Teeth
• Intervention / Treatment: Device: Copper Nickel titanium arch wire

Detailed Description

Leveling and alignment is the first stage in fixed orthodontic treatment, performed for every patient. Copper nickel titanium (CuNiTi) was modified from conventional nickel titanium (NiTi) to stabilize the super elasticity properties of the initial nickel titanium (NiTi) arch wire against cyclic deformation. The addition of copper to traditional nickel titanium enhances thermal reactive properties and consistency of forces.so the aim of the study is to Evaluate the efficiency of using copper nickel titanium (CuNiTi) arch wire on the initial stage of leveling and alignment regarding their rate of alignment.

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

Contacts and Locations

• Study Contact: Name: Mohamed El Gendy, BDS; Phone Number: 01062266555; Email: mohamed.bedir@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 12613
      • Recruiting
      • Faculty of Dentistry, Cairo University
      • Contact: - Faculty Official Mail; Phone Number: (+202) 23634965; Email: dentmail@dentistry.cu.edu.eg
      • Contact: Information mail; Phone Number: (+202) 23642938; Email: info@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients aged (18~33).
2. Moderate crowding (4-8)10.
3. No extractions required.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Missing teeth other than the wisdoms.
3. Patient with dental anomalies.
4. Patient having a deep bite, open bite or cross bite.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Nickel titanium NiTi arch wire (Gold Standard, control group); Patient will receive 0.014 round Nickel titanium NiTi archwire and will be ligated using a ligature wire with Follow up for 2 months.	Device: Copper Nickel titanium arch wire; Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire.; Other Names: CuNiTi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of alignment.	Measuring the amount and rate of alignment of teeth which achieved every 2 weeks for a period of 8 weeks using (mm) as numerical unit of measurement and method of measurement is '' Little's irregularity index''	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inter-canine arch perimeter width	measure inter canine perimeter width every 2 weeks using Unit of measurement numerical (mm) though ortho analyzer 3shape software	8 weeks
pain assessed by NRS	measuring pain associated after placement of the wire through printed copy of numerical rating pain scale with a person rates their pain on a scale of 0 to 10,Zero means "no pain," while 10 means "the worst possible pain."	first 24 hours
inter-molar arch perimeter width.	measure inter-molar arch perimeter width every 2 weeks using a numerical unit of measurement (mm) through ortho analyzer 3shape software	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 18, 2021
• Primary Completion (ANTICIPATED): March 18, 2022
• Study Completion (ANTICIPATED): April 18, 2022

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (ACTUAL): March 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper; Nickel
• Other Study ID Numbers: 25121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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