Crowding of Anterior Mandibular TeethNCT04815200
Efficiency of Using Copper-Nickel-Titanium Versus Nickel-Titanium Arch Wires on Anterior Segment Crowding Alleviation in Group of Adults With Moderate Crowding
A study testing Copper Nickel titanium arch wire in people with Crowding of Anterior Mandibular Teeth, run by Cairo University at 1 site in Egypt.
Trial 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. . Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- Copper Nickel titanium arch wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2021to 18 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aged (18~33).
- Moderate crowding (4-8)10.
- No extractions required.
Who cannot join
- Previous orthodontic treatment.
- Missing teeth other than the wisdoms.
- Patient with dental anomalies.
- Patient having a deep bite, open bite or cross bite.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Cairo University
Cairo, Manial, 12613
- Faculty Official Mail, (+202) 23634965, dentmail@dentistry.cu.edu.eg
Information mail, (+202) 23642938, info@dentistry.cu.edu.eg
About this study
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
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.
.
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.
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- Copper Nickel titanium arch wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Nickel titanium arch wireDevice
Also called CuNiTi
Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Copper Nickel titanium arch wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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''
Measured: 8 weeks
Secondary outcomes (3)
inter-canine arch perimeter width
measure inter canine perimeter width every 2 weeks using Unit of measurement numerical (mm) though ortho analyzer 3shape software
Measured: 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."
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start18 Mar 2021 (estimated)
- Primary completion18 Mar 2022 (estimated)
- Study completion18 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding of Anterior Mandibular TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Bedir Abd El Hady El Gendy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815200
- Sponsor's protocol ID
- 25121
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04815200
- Acronym / sponsor ID
- 25121
- Conditions
- Crowding of Anterior Mandibular Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Mar 2021 (estimated)
- Primary completion
- 18 Mar 2022 (estimated)
- Study completion
- 18 Apr 2022 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire
| Arm | Type | Receives |
|---|---|---|
| Nickel titanium NiTi arch wire (Gold Standard, control group) | Other | Device: Copper Nickel titanium arch wirePatient will receive 0.014 round Nickel titanium NiTi archwire and will be ligated using a ligature wire with Follow up for 2 months. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged (18~33).
- Moderate crowding (4-8)10.
- No extractions required.
Key exclusion criteria (4 listed)
- Previous orthodontic treatment.
- Missing teeth other than the wisdoms.
- Patient with dental anomalies.
- Patient having a deep bite, open bite or cross bite.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper Nickel titanium arch wireAlso: CuNiTiPatient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire. | Device | Nickel titanium NiTi arch wire (Gold Standard, control group) |
Primary outcome
Rate of alignment.
Time frame: 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''
3 secondary outcomes
inter-canine arch perimeter width
Time frame: 8 weeks
pain assessed by NRS
Time frame: first 24 hours
inter-molar arch perimeter width.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper Nickel titanium arch wire in people with Crowding of Anterior Mandibular Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed El Gendy, BDS (01062266555, mohamed.bedir@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of alignment. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.