Ferumoxytol Nanozymes for Biofilm Disruption: A Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The change in bacterial count between the experimental group (Ferumoxytol/H2O2) and the standard of care (NaOCl) group.
研究概览
简要总结
The antimicrobial efficacy and healing potential of clinically approved ferumoxytol nanozymes versus the standard 3% NaOCl irrigant will be evaluated in adults undergoing endodontic treatment. Building on prior protocols that demonstrated ferumoxytol nanozymes antimicrobial activity as a root canal irrigant, ferumoxytol solution will be applied topically, assessment of clinical and radiographical findings will determine its potential as a novel disinfection and its long-term outcome.
详细描述
This study aims to fill critical knowledge gaps identified in prior clinical findings by optimizing the integration of nanozymes into endodontic workflows and thereby improving treatment outcomes for teeth with apical periodontitis. The study will evaluate the topical application of a low-dose ferumoxytol formulation (Feraheme/H2O2) within the prepared canal system of patients undergoing routine root canal therapy. Antimicrobial efficacy will be compared to the standard sodium hypochlorite irrigant via intracanal microbial sampling. Periapical tissue regeneration and long-term clinical outcomes will be assessed at 6-month and 1-year follow-up intervals using cone-beam computed tomography (CBCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to participate in the study.
- •Patients are 18 years or above.
- •Non-contributory medical history (Patient can be seen for regular dental appointment in PDM; ASA classes I and II).
- •Tooth requiring root canal treatment with radiographic presence of periapical radiolucency and
- •responding to thermal sensitivity testing negatively (Difluordichlormethane at 50 °C, Endo-Ice,
- •Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or a negative response to EPT testing.
- •Tooth with adequate remaining tooth structure for proper isolation with rubber dam.
- •No history of previous endodontic treatment on the tooth.
- •Teeth with single roots or multirooted teeth.
排除标准
- •Self-reported pregnancy.
- •Patients requiring antibiotic premedication prior to dental treatment.
- •Patients with multiple drug allergies.
- •Patients with known hypersensitivity to Ferumoxytol nanoparticles or any iron products.
- •Patients who are scheduled for MRI for the head region within three months after Ferumoxytol nanoparticles application.
- •Periodontal changes (pockets 3 mm, mobility Grade I, or gingival edema).
- •Patients who cannot return for a subsequent appointment or follow-ups.
- •Radiographic presence of resorptive processes.
- •Cracked and fractured teeth.
研究组 & 干预措施
Nanozyme treatment
After access preparation with sterile burs and sterile saline irrigation and working length determination, 2 mL of a mixture of Ferumoxytol (6mg/mL)/H2O2(3%) will be introduced into the canal. The root canal systems will be instrumented with XP-Shaper rotary files, a total of 8 mL of solution will be used, and a total contact time of 10 minutes.
干预措施: Nanozyme treatment (Drug)
Sodium hypochlorite
After access preparation with sterile burs and sterile saline irrigation and working length determination, 2 mL of a mixture of sodium hypochlorite (NaOCl) will be introduced into the canal. The root canal systems will be instrumented with XP-Shaper rotary files, a total of 8 mL of NaOCl solution will be used, and a total contact time of 10 minutes.
干预措施: Control (Standard treatment) (Drug)
结局指标
主要结局
The change in bacterial count between the experimental group (Ferumoxytol/H2O2) and the standard of care (NaOCl) group.
时间窗: 1 Year
By measuring reduction in bacteria colony forming units (CFU) before and after treatment for the experimental group (Ferumoxytol/H2O2) and the standard of care (NaOCl) group, then comparing the two groups. Samples 1-2 will be taken during the first root canal treatment visit. Sample 1 before cleaning or shaping the root canal. Sample 2 after cleaning and shaping of the root canal using laser or NaOCl. Sample 3 will be taken in the second visit, upon completion of final routine irrigation protocol.
次要结局
- Periapical Bone Changes from Baseline in Periapical Radiographs at 6, 12, and 24 Months Follow Up(2 Years)
研究者
Bekir Karabucak
Chair and Professor of Endodontics
University of Pennsylvania