Effect of Local Subperiosteal Zoledronic Acid Injection on the Survival of Orthodontic Miniscrews

NCT07546058 | Completed

• 1 other identifier: LatakiaU
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Orthodontic Appliance Complication

Keywords

Orthodontic miniscrews; Temporary anchorage devices; Bisphosphonates; Zoledronic acid; Anchorage reinforcement

Outcome Measures

Primary Outcomes (1)

• Mobility

  Proportion of orthodontic miniscrews with no clinical mobility during follow-up, assessed by manual clinical examination

  6 months

Secondary Outcomes (1)

• Peri-miniscrew inflammation

  6 months

Study Arms (2)

Intervention (Zoledronic Acid)

EXPERIMENTAL

zoledronic acid administered miniscrews

Drug: Zoledronic Acid

Placebo / Saline Group

PLACEBO COMPARATOR

saline administered miniscrews

Drug: Normal saline (0.9% sodium chloride)

Interventions

Zoledronic Acid DRUG

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.

Also known as: Bisphosphonate

Intervention (Zoledronic Acid)

Normal saline (0.9% sodium chloride) DRUG

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.

Placebo / Saline Group

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mild to moderate skeletal Class II Division 1 malocclusion with full-cusp Class II molar relationship, ANB angle between 4° and 6°, normal maxilla-mandibular plane angle (25° ± 5°), and indication for first premolar extraction to reduce overjet.

You may not qualify if:

• Periodontal disease or alveolar bone loss.
• Craniofacial deformities.
• Cleft lip or palate.
• Impacted or missing teeth in the treatment area.
• Systemic diseases or current medication affecting bone metabolism.
• Poor gingival health.
• Smoking or inadequate oral hygiene.

Sponsors & Collaborators

• Latakia University: lead

Study Sites (1)

Latakia University

Latakia, Latakia Governorate, Syria

Location

Related Publications (5)

• Feldmann I, Bondemark L. Orthodontic anchorage: a systematic review. Angle Orthod 2006;76:493-501.

  RESULT

• Ganzer N, Feldmann I, Bondemarkc L. Anchorage reinforcement with miniscrews and molar blocks in adolescents: A randomized controlled trial. Am J Orthod Dentofacial Orthop 2018;154:758-67

  RESULT

• Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010;137:194-9

  RESULT

• Moghaddam S, Mohammadi A, Behroozian A. The effect of sandblasting and acid etching on survival rate of orthodontic miniscrews: a split-mouth randomized controlled trial. Progress in Orthodontics 2021; 22:2.

  RESULT

• Kloehn SJ. Orthodontics-force or persuasion. Angle Orthod 1953; 23:55-65

  RESULT

MeSH Terms

Interventions

Zoledronic Acid; Diphosphonates; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shadi G Moawad, Ph.D

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 22, 2026
• Study Start: December 1, 2024
• Primary Completion: November 2, 2025
• Study Completion: February 3, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)