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临床试验/NCT07546058
NCT07546058已完成不适用

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

Latakia University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Mobility

研究概览

简要总结

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).

详细描述

Anchorage in orthodontics refers to resistance against unwanted tooth movements during treatment. Numerous methods and devices have been utilized over time to reinforce anchorage. Although effective, these traditional techniques present certain limitations.

Recently, mini-implants, or temporary anchorage devices (TADs), have gained popularity as reliable tools for facilitating controlled tooth movement without relying on patient compliance. Nonetheless, miniscrews can encounter complications including mobility and failure during treatment. Clinically, miniscrew success is generally assessed by absence of inflammation, mobility, or significant pain, along with their capacity to withstand orthodontic forces. A systematic review and meta-analysis estimated that TAD failure occurs in approximately 13.5% of cases, with mandibular placements showing a higher failure rate (16.5%) compared to maxillary ones (11.0%).

Bisphosphonates (BPs) are synthetic compounds analogous to pyrophosphates.They are mainly prescribed to manage excessive bone resorption associated with skeletal disorders, primarily by modulating bone remodeling and repair.

The biological effects of bisphosphonates can be categorized into:

  • Tissue level: BPs reduce bone turnover, thereby diminishing both bone resorption and formation.
  • Cellular level: Osteoclasts are the primary targets, with bisphosphonates inhibiting their recruitment, suppressing activity, shortening lifespan, and modifying bone mineral properties to slow dissolution independently of cellular processes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 28 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Intervention (Zoledronic Acid)

Experimental

zoledronic acid administered miniscrews

干预措施: Zoledronic Acid (Drug)

Placebo / Saline Group

Placebo Comparator

saline administered miniscrews

干预措施: Normal saline (0.9% sodium chloride) (Drug)

结局指标

主要结局

Mobility

时间窗: 6 months

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

次要结局

  • Peri-miniscrew inflammation(6 months)

研究者

发起方
Latakia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shadi Moawad

Assistant Professor

Latakia University

研究点 (1)

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