Effect of Local Subperiosteal Zoledronic Acid Injection on the Survival of Orthodontic Miniscrews
Summary
A triple-blind, split-mouth randomized controlled trial (NCT07546058) registered on ClinicalTrials.gov under NIH, evaluating whether local subperiosteal zoledronic acid injections at 1 mg/mL concentration improve orthodontic miniscrew survival rates. The study enrolled 68 patients requiring bilateral maxillary premolar extraction, with miniscrews placed bilaterally and randomized to receive either zoledronic acid or saline control injections administered weekly for three weeks, with primary outcome assessed at 6 months.
“Orthodontic miniscrews are widely used as temporary anchorage devices; however, failure remains a clinical concern.”
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A clinical trial registration for a triple-blind, split-mouth randomized controlled trial evaluating the effect of local subperiosteal zoledronic acid (ZA) injection on orthodontic miniscrew survival and peri-miniscrew inflammation. The study enrolled 68 patients requiring bilateral maxillary premolar extraction; miniscrews were placed bilaterally with one side receiving 0.5 mL zoledronic acid at 1 mg/mL and the contralateral side saline, with weekly injections for three weeks and orthodontic force applied 24 hours after the final injection.
This trial registration is informational and does not create compliance obligations. Compliance officers monitoring pharmaceutical or orthodontic device research may note this as an active clinical investigation in temporary anchorage device survival, with bisphosphonate local application as the novel intervention being tested.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Effect of Local Subperiosteal Zoledronic Acid Injection on the Survival of Orthodontic Miniscrews
N/A NCT07546058 Kind: NA Apr 22, 2026
Abstract
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).
Conditions: Orthodontic Appliance Complication
Interventions: Zoledronic Acid, Normal saline (0.9% sodium chloride)
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