CClinicalTrials.gg
Status unknownNCT04815200Updated Mar 24, 2021

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

An interventional study of Copper Nickel titanium arch wire in Crowding of Anterior Mandibular Teeth, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 33 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 33 Years
Sex
All
01

Study 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.

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Read the 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.

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Conditions studied

  • Crowding of Anterior Mandibular Teeth
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 33 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceCopper Nickel titanium arch wire

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

    Also known as: CuNiTi

06

What researchers measure

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''

    Time frame: 8 weeks

Secondary outcomes

  1. inter-canine arch perimeter width

    measure inter canine perimeter width every 2 weeks using Unit of measurement numerical (mm) though ortho analyzer 3shape software

    Time frame: 8 weeks

  2. 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."

    Time frame: first 24 hours

  3. 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

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04815200
Lead sponsor
Cairo University
Responsible party
Mohamed Ibrahim Bedir Abd El Hady El Gendy (master student, department of orthodontics, Cairo University, Cairo University) — Principal investigator
First posted
Mar 24, 2021
Start date
Mar 18, 2021 (estimated)
Primary completion
Mar 18, 2022 (estimated)
Completion
Apr 18, 2022 (estimated)
Last update
Mar 24, 2021

Study contacts

Mohamed El Gendy, BDS
Contact
mohamed.bedir@dentistry.cu.edu.eg
01062266555

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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