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

NCT04815200 | Unknown DMC

• 1 other identifier: 25121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. .

Conditions

Crowding of Anterior Mandibular Teeth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• inter-canine arch perimeter width

  8 weeks

• pain assessed by NRS

  first 24 hours

• inter-molar arch perimeter width.

  8 weeks

Study Arms (1)

Nickel titanium NiTi arch wire (Gold Standard, control group)

OTHER

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

Interventions

Copper Nickel titanium arch wire DEVICE

Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire.

Also known as: CuNiTi

Nickel titanium NiTi arch wire (Gold Standard, control group)

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged (18\~33).
• Moderate crowding (4-8)10.
• No extractions required.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of dentistry, Cairo University

Cairo, Manial, 12613, Egypt

RECRUITING

Central Study Contacts

Mohamed El Gendy, BDS

CONTACT

01062266555; mohamed.bedir@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: i) To participant (subjects): Patients can be blinded as they do not know the type of wire used. ii) To Assessor: The assessor (different than the main operator) will carry out the measurements blindly on the pre and post models.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student, department of orthodontics, Cairo University

Model Details: Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 24, 2021
• Study Start: March 18, 2021
• Primary Completion: March 18, 2022
• Study Completion: April 18, 2022
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

EG (1)