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Not yet recruitingNCT07813117Updated Sep 10, 2026

Clinical Evaluation of Zirconium Dioxide Nano-Coated Arch Wires

An interventional study of Zirconium dioxide nano-coated archwire and Conventional orthodontic archwire in Malocclusion of Anterior Teeth, sponsored by Al-Azhar University. Not yet recruiting. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
13 Years to 19 Years
Sex
All
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Study summary

"This clinical trial aims to evaluate the clinical performance and efficiency of zirconium dioxide nano-coated orthodontic archwires compared to conventional archwires. The study focuses on assessing the leveling and alignment duration, as well as evaluating patient comfort and clinical outcomes during the initial stages of orthodontic treatment."

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Conditions studied

  • Malocclusion of Anterior Teeth

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03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 20 is below the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants within the age range of 13 to 19 years.
  • Moderate crowding (4-6 mm) in the maxillary anterior segment, evaluated using the Little Irregularity Index (LII), indicating the need for treatment with a fixed appliance without extractions.
  • Patients in permanent dentition with all teeth had fully erupted ( excluding 3rd molars)
  • Good oral hygiene.
  • No previous orthodontic treatment.

Exclusion criteria

Exclusion Criteria:

  • Transverse and/or vertical skeletal dysplasia or craniofacial malformation
  • Retained primary or missing permanent teeth in the maxillary anterior area.
  • Present or history of periodontal diseases.
  • Physical or mental disability.
  • Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Zirconium Dioxide Nano-Coated Archwire Group

    Patients will receive orthodontic treatment using zirconium dioxide nano-coated archwires.

    Device: Zirconium dioxide nano-coated archwire

  • Placebo comparator
    Conventional Archwire Group

    Patients will receive conventional orthodontic archwires during treatment.

    Device: Conventional orthodontic archwire

Interventions

  • DeviceZirconium dioxide nano-coated archwire

    Zirconium dioxide nano-coated nickel-titanium archwire used during the leveling and alignment phase of fixed orthodontic treatment, compared against conventional uncoated NiTi archwires."

  • DeviceConventional orthodontic archwire

    Conventional orthodontic archwire used during the leveling and alignment phase of fixed orthodontic treatment, compared against Zirconium dioxide nano-coated nickel-titanium archwire

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What researchers measure

Primary outcomes

  1. Rate of dental alignment

    Little's Irregularity Index (unabbreviated scale title). The index measures the linear displacement of the five anatomic points of the anterior teeth. Scores range from a minimum of 0 (representing perfect alignment with no displacement) to a maximum of 10 or higher (representing severe dental crowding and irregularity). Lower scores indicate a better outcome (greater dental alignment and successful leveling phase).

    Time frame: Measured at baseline and every 4 weeks up to 16 weeks .

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • TY - JOUR AU - Fahmy, Ragi AU - Mohamed, Kareem AU - Mohamed, Wael AU - Refai, Mobarak PY - 2024/07/17 SP - T1 - Effect of Zirconium Dioxide Nanoparticles Coating of Orthodontic Appliance on The Rate of Maxillary Canine Retraction (Randomized Control Study) VL - DO - 10.48047/AFJBS.6.Si4.2024.859-870 ER -

Individual participant data

Plan to share: Yes — Yes, individual participant data that underlie the results reported in the publication will be shared after de-identification, beginning 3 months and ending 5 years following article publication, to researchers who provide a methodologically sound proposal

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Beginning 3 months and ending 5 years following article publication.

Access criteria: Requests should be directed to the corresponding author via email. Access will be granted to researchers whose proposed use of the data has been approved by an independent review committee for individual participant data meta-analyses.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 12 months is below that.

Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 10, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, 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
NCT07813117
Responsible party
Mohamed Elsayed Desoky (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Sep 10, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Mohamed E Desoky, postgraduate student
Contact
mohameddosoky757@gmail.com
+201020353336 ext. +20
Raafat E Mohamed, Professor
study director · Al-Azhar University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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