Strontium-hydroxyapatite coated orthodontic mini-screws for improved stability and infection control
Evaluation Stability the Antibacterial Efficacy and of Strontium Incorporated Hydroxyapatite [Sr-HA] Coated Mini-screws Used for Maxillary Canine Retraction: A Randomized Clinical Trial
This trial will test whether strontium‑incorporated hydroxyapatite coatings on orthodontic mini-screws reduce bacterial colonization and improve screw stability in patients aged 16–20 undergoing maxillary canine retraction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 16 Years to 20 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT07105969 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, split‑mouth clinical trial in 20 patients (age 16–20) comparing a 5% strontium‑incorporated hydroxyapatite (Sr‑HA) electrochemically coated titanium mini‑screw to an uncoated control placed contralaterally. Self‑drilling 1.6 × 8 mm titanium alloy mini‑screws are inserted between the upper second premolar and first molar without flap elevation or pilot holes, then loaded with 150 g NiTi coil springs for canine retraction on 17×25 SS archwires. Outcomes including screw stability, antimicrobial activity around the screws, and gingival blood flow are monitored over a four‑month follow‑up. The split‑mouth design and periapical radiographs are used to control for patient-level factors and ensure safe screw placement.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16–20 undergoing fixed orthodontic treatment with planned upper first premolar extractions and maxillary canine retraction, who have good oral hygiene and no contraindicating medical conditions.
Not a fit: Patients with poor oral hygiene, heavy smoking, compromised healing (eg, immune deficiency, bleeding disorders, pathological bone quality, xerostomia), or who cannot attend follow‑up visits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, Sr‑HA coating could reduce peri‑screw bacterial infection and increase mini‑screw anchorage stability, potentially lowering failure rates and treatment delays.
How similar studies have performed: Preclinical and dental implant studies have shown that Sr‑HA can enhance bone integration and reduce bacterial colonization, but clinical evidence specifically for orthodontic mini‑screws remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients within an age range (16-20) years. 2. Orthodontic treatment plan requiring the extraction of the upper first premolars. 3. Patients have fully permanent teeth are erupted (third molars are not included). 4. No previous orthodontic treatment 5. No medical problem that could interfere with treatment. Exclusion Criteria: 1. Presence of problematic healing such as, compromised immune defense, bleeding disorder, pathological bone quality, and xerostomia. 2. Inadequate oral hygiene. 3. Heavy smoking
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura university — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Hind H jasim Al-khazrajy, Bachelors
- Email: hindhhjk@gmail.com
- Phone: 01555178219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.