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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04815200

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crowding of Anterior Mandibular Teeth	Device: Copper Nickel titanium arch wire	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 18, 2021

Anticipated Primary Completion Date :

Mar 18, 2022

Anticipated Study Completion Date :

Apr 18, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of alignment. [8 weeks]
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''

Secondary Outcome Measures

inter-canine arch perimeter width [8 weeks]
measure inter canine perimeter width every 2 weeks using Unit of measurement numerical (mm) though ortho analyzer 3shape software
pain assessed by NRS [first 24 hours]
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."
inter-molar arch perimeter width. [8 weeks]
measure inter-molar arch perimeter width every 2 weeks using a numerical unit of measurement (mm) through ortho analyzer 3shape software

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 33 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry, Cairo University	Cairo	Manial	Egypt	12613

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Ibrahim Bedir Abd El Hady El Gendy, master student, department of orthodontics, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT04815200

Other Study ID Numbers:

25121

First Posted:

Mar 24, 2021

Last Update Posted:

Mar 24, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Copper

Nickel

Study Results

No Results Posted as of Mar 24, 2021