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RecruitingNCT07521267Updated Apr 13, 2026

Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch

An interventional study of Silver nanoparticles and uncoated titanium miniscrews in Class I Malocclusion, Maxillary Prognathism and Orthodontic Tooth Movement, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 14 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

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

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
14 Years to 20 Years
Sex
All
01

Study summary

study will be directed to evaluate silver-hydroxyapatite nano-coated versus uncoated orthodontic miniscrews for en masse retraction of the upper anterior segment.

Read the detailed description

Silver-hydroxyapatite nanoparticles (Ag-HA NPs) have lately gained popularity in dentistry due to their unique combination of silver antibacterial activity and hydroxyapatite's osteoconductive, remineralizing characteristics. Ag-HA has shown potential in resolving two important clinical issues: infection control and anchoring stability. Coating orthodontic miniscrews with Ag-HA NPs has been demonstrated to reduce peri-implant biofilm growth by their antimicrobial effect, minimizing inflammation, and increasing osseointegration, thus increasing the long-term success of temporary anchoring devices (TADs).

02

Conditions studied

  • Class I Malocclusion
  • Maxillary Prognathism
  • Orthodontic Tooth Movement
03

In context

Malocclusion, Angle Class I

35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.

This study's planned enrollment of 14 is below the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.

Browse Malocclusion, Angle Class I 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.

04

Who can participate

Ages eligible
14 Years to 20 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

  • Class I orthodontic cases with bimaxillary protrusion of the anterior segment of the upper jaw that need at least extraction for orthodontic treatment.
  • Age 14-20 years.
  • Good oral hygiene with healthy periodontium.
  • Need for an absolute skeletal anchorage.
  • Systemically healthy patients.

Exclusion criteria

Exclusion Criteria:

  • Patient with craniofacial anomalies (e.g, cleft lip and palate)
  • Presence of systemic diseases or syndromes affecting bone metabolism (e.g, osteoporosis, rickets)
  • Poor oral hygiene or uncooperative patients.
  • Extensive dental caries or untreated periodontal disease.
  • History of trauma or surgery affecting the maxilla or mandible.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    silver-hydroxyapatite nanocoated titanium miniscrews

    Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews. These miniscrews will be placed in the maxillary bone for en masse retraction of the upper anterior teeth.

    Device: Silver nanoparticles

  • Active comparator
    uncoated titanium miniscrews

    Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as Arm 1, but without nano-coating.

    Device: uncoated titanium miniscrews

Interventions

  • DeviceSilver nanoparticles

    Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews.These miniscrews will be placed in the maxillary bone for en masse retractonof the upper anterior teeth.

  • Deviceuncoated titanium miniscrews

    Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as the intervention of the group1, but without nano-coating.

06

What researchers measure

Primary outcomes

  1. Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction

    Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction

    Time frame: about 6 months

Secondary outcomes

  1. Assessment of the rate of en masse retraction of the anterior segment of the upper arch

    Assessment of the rate of en masse retraction of the anterior segment of the upper arch.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Data Will not be Shared Due to Privacy Consideration.

No publications or documents are linked to this record.

09

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 May 2026; primary completion for Jun 2028, 25 months later.

Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's planned 25 months is above that.

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

Registered
Apr 3, 2026
First posted
Apr 9, 2026
StartEst.
May 2026
Primary completionEst.
Jun 2028
CompletionEst.
Nov 2029
Last update
Apr 13, 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 Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07521267
Responsible party
Hashem Khalil Saleh Mohammed (Principle Investigator, MSc Candidate in Orthodontics, Al-Azhar University) — Principal investigator
First posted
Apr 9, 2026
Start date
May 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Nov 2029 (estimated)
Last update
Apr 13, 2026

Study contacts

Hashem Kh Al-Washali, MScCandidate
Contact
Hashemalwashali.2.209@azhar.edu.eg
+01120042296
Mahmoud FA Aboelmahasen, Phd
Contact
MahmoudFathy.209@azhar.edu.eg
+01222993318
Mahmoud FA Aboelmahasen, Phd
study director · Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt
Ahmed Ak El-Awady, Phd
study director · Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt

Oversight

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

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