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Effect of Local Subperiosteal Zoledronic Acid Injection on the Survival of Orthodontic Miniscrews
Sponsor: Latakia University
Summary
Background: Orthodontic miniscrews are widely used as temporary anchorage devices; however, failure remains a clinical concern. Bisphosphonates may enhance bone stability, but evidence on their local application is limited. Objective: To evaluate the effect of local subperiosteal zoledronic acid (ZA) injection on miniscrew survival and peri-miniscrew inflammation. Materials and Methods: This triple-blind, split-mouth randomized controlled trial included 68 patients requiring bilateral maxillary premolar extraction. Miniscrews were placed bilaterally, with one side randomly receiving a 0.5 mL solution of zoledronic acid at 1 mg/mL concentration and the contralateral side saline. Injections were administered weekly for three weeks. Orthodontic force (\~250 g) was applied 24 hours after final injection. The primary outcome was miniscrew survival at 6 months. Paired comparisons were analyzed using McNemar test, with odds ratios (ORs) and 95% confidence intervals (CIs).
Key Details
Gender
All
Age Range
17 Years - 28 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2024-12-01
Completion Date
2026-02-03
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
Zoledronic Acid
Zoledronic acid was prepared at a concentration of 1 mg/mL according to the manufacturer's instructions (ADMAC Pharmaceuticals). A volume of 0.5 mL was injected subperiosteally adjacent to miniscrews on the experimental side. Dose calculation was based on conversion from animal studies using the human equivalent dose (HED) formula.39,40 The calculated HED was 0.0216 mg/kg, corresponding to approximately 1.296 mg for a 60-kg individual. One week after placement, injections were administered weekly for three consecutive sessions.
Normal saline (0.9% sodium chloride)
Three local subperiosteal injections of sterile 0.9% saline solution were administered at the orthodontic miniscrew insertion sites, beginning one week after placement and repeated at weekly intervals for three consecutive sessions, serving as an inert control without pharmacological effect.
Locations (1)
Latakia University
Latakia, Latakia Governorate, Syria