Strontium-Hydroxyapatite Coated Mini-Screws: Antibacterial Effect and Stability

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Mar 14, 2026 to Aug 14, 2026
    • Study completion date changed from estimate of May 14, 2026 to Oct 14, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 14 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv3
  3. Primary endpoint revised
    • Secondary endpoints: details revised at 1 of 1 entry
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized controlled clinical trial aims to evaluate the antibacterial efficacy and stability of strontium-incorporated hydroxyapatite (Sr-HA) coated orthodontic mini-screws (OMSs) used for maxillary canine retraction. A double-blind, split-mouth design was employed, involving 20 patients (aged 16-20 years), each receiving two titanium alloy mini-screws (1.6 mm × 8 mm): one coated with Sr-HA (5% concentration via electrochemical deposition) and one uncoated control. A total of 40 mini-screws were assessed. Following upper first premolar extractions, canine retraction was initiated using 150 g NiTi coil springs on 17×25 SS archwires. Mini-screws were placed between the upper second premolar and first molar without flap elevation or pilot hole drilling. Parameters including screw stability, antimicrobial activity, and gingival blood flow were monitored over a 4-month period. The incorporation of Sr-HA is hypothesized to enhance mini-screw osseointegration, reduce peri-implant inflammation, and improve clinical outcomes by leveraging the osteogenic and antibacterial properties of strontium. This study aims to provide evidence supporting the use of Sr-HA coatings to reduce mini-screw failure rates in orthodontic treatment.
Trial Details
NCT Number NCT07105969
Lead Sponsor Mansoura University
Conditions
(from sponsor)		 Gingival Inflammation and Loss the Orthodontic Mini-screws
Related terms Gingivitis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov