Malocclusion of Anterior TeethNCT07813117
Clinical Evaluation of Zirconium Dioxide Nano-Coated Arch Wires
A study testing Zirconium dioxide nano-coated archwire and Conventional orthodontic archwire in people with Malocclusion of Anterior Teeth, run by Al-Azhar University.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Malocclusion of Anterior Teeth
- What is being tested?
- Zirconium dioxide nano-coated archwire and Conventional orthodontic archwire
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Role of Zirconium Dioxide Nanocoating of Arch Wires on the Rate of Orthodontic Tooth Movement During Leveling and Alignment: A Comparative Clinical Study
"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."
- Conditions
- Malocclusion of Anterior Teeth
- Being tested
- Zirconium dioxide nano-coated archwire, Conventional orthodontic archwire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium dioxide nano-coated archwireDevice
Zirconium dioxide nano-coated nickel-titanium archwire used during the leveling and alignment phase of fixed orthodontic treatment, compared against conventional uncoated NiTi archwires."
Conventional orthodontic archwireDevice
Conventional orthodontic archwire used during the leveling and alignment phase of fixed orthodontic treatment, compared against Zirconium dioxide nano-coated nickel-titanium archwire
| Study group | Role | What they receive |
|---|---|---|
| Zirconium Dioxide Nano-Coated Archwire Group | Experimental | Patients will receive orthodontic treatment using zirconium dioxide nano-coated archwires. Receives: Device: Zirconium dioxide nano-coated archwire |
| Conventional Archwire Group | Placebo comparator | Patients will receive conventional orthodontic archwires during treatment. Receives: Device: Conventional orthodontic archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Measured at baseline and every 4 weeks up to 16 weeks .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malocclusion of Anterior TeethStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsayed Desoky, Al-Azhar University
- Investigators
- Raafat E Mohamed, Professor, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813117
- Sponsor's protocol ID
- EC Ref No.1218/1494
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
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 -
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Role of Zirconium Dioxide Nanocoating of Arch Wires on the Rate of Orthodontic Tooth Movement During Leveling and Alignment: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT07813117
- Acronym / sponsor ID
- EC Ref No.1218/1494
- Conditions
- Malocclusion of Anterior Teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 Sep 2026 (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.
"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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconium Dioxide Nano-Coated Archwire Group | Experimental | Device: Zirconium dioxide nano-coated archwirePatients will receive orthodontic treatment using zirconium dioxide nano-coated archwires. |
| Conventional Archwire Group | Placebo comparator | Device: Conventional orthodontic archwirePatients will receive conventional orthodontic archwires during treatment. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Zirconium dioxide nano-coated archwireZirconium dioxide nano-coated nickel-titanium archwire used during the leveling and alignment phase of fixed orthodontic treatment, compared against conventional uncoated NiTi archwires." | Device | Zirconium Dioxide Nano-Coated Archwire Group |
| Conventional orthodontic archwireConventional orthodontic archwire used during the leveling and alignment phase of fixed orthodontic treatment, compared against Zirconium dioxide nano-coated nickel-titanium archwire | Device | Conventional Archwire Group |
Primary outcome
Rate of dental alignment
Time frame: Measured at baseline and every 4 weeks up to 16 weeks .
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Results publicationTY - 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 dataSharing planned: 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
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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.
Raafat E Mohamed, Professor study director
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A study testing Zirconium dioxide nano-coated archwire and Conventional orthodontic archwire in people with Malocclusion of Anterior Teeth, run by Al-Azhar University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Desoky, postgraduate student (+201020353336 ext. +20, mohameddosoky757@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dental alignment (time frame: Measured at baseline and every 4 weeks up to 16 weeks .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813117, which also lists 1 linked publication.
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 10 Sep 2026.