Nano-coated miniscrews for pulling back the upper front teeth

Evaluation of Silver-Hydroxyapatite Nano-coated Versus Uncoated Orthodontic Miniscrews for en Masse Retraction of the Upper Anterior Segment: A Randomized Clinical Trial

This test will try whether silver-hydroxyapatite nano-coated miniscrews reduce infection and improve anchorage when pulling back the upper front teeth in healthy 14–20-year-olds.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 14 Years to 20 Years
• Sex: All
• Sponsor: Al-Azhar University (other)
• Locations: 1 site (Cairo, Cairo Governorate)
• Trial ID: NCT07521267 on ClinicalTrials.gov

What this trial studies

This interventional comparison places silver-hydroxyapatite (Ag-HA) nanoparticle-coated titanium miniscrews versus standard uncoated titanium miniscrews to support en masse retraction of the upper anterior segment. The coated screws are intended to combine silver's antibacterial activity with hydroxyapatite's osteoconductive properties to limit peri-implant biofilm and boost osseointegration. Outcomes will include measures of peri-implant biofilm growth, local inflammation, anchorage stability, and clinical success of the temporary anchorage devices. Participants are healthy adolescents and young adults requiring extraction-based orthodontic retraction and with good oral hygiene.

Who should consider this trial

Good fit: Ideal candidates are systemically healthy 14–20-year-olds with Class I bimaxillary protrusion who need extraction and absolute skeletal anchorage and who have good oral hygiene and healthy gums.

Not a fit: Patients with craniofacial anomalies, systemic bone metabolism disorders, poor oral hygiene, untreated periodontal disease, extensive caries, or prior trauma/surgery to the jaws are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the coating could lower infection and inflammation around miniscrews and improve their anchorage stability, reducing failures and complications during treatment.

How similar studies have performed: Preclinical and some dental-implant studies show Ag-HA materials reduce biofilm and promote osseointegration, but clinical data specifically on orthodontic miniscrews remain limited.

Eligibility criteria

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:

* 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.

Where this trial is running

Cairo, Cairo Governorate

• Faculty of Dental Medicine (Boys), Al-Azhar University — Cairo, Cairo Governorate, Egypt (RECRUITING)

Study contacts

• Study coordinator: Hashem Kh Al-Washali, MScCandidate

Conditions: Class I Malocclusion, Maxillary Prognathism, Orthodontic Tooth Movement