Nanozymes in Endodontics

Официальное название

Ferumoxytol Nanozymes for Biofilm Disruption: A Clinical Study

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат Nanozyme treatment
  Experimental arm: topical intra-canal irrigation with ferumoxytol (Feraheme®) diluted to 6 mg/mL in 0.1 M sodium acetate, activated with 3% H₂O₂. The solution is instilled into an isolated, dried canal, physically agitated for \~60 s to promote nanozyme activation and convective mixing, held for a brief contact time (\<10 min), then aspirated per SOP; post-treatment intracanal sterile paper-point samples are collected. Topical nanozyme mechanism (catalytic ROS generation from low-dose H₂O₂), def
• Препарат Control (Standard treatment)
  Control arm: standard clinical irrigation with 3% sodium hypochlorite (NaOCl) using matched total volume and institutional activation method, with identical pre/post sampling and follow-up.

Первичные конечные точки

• The change in bacterial count between the experimental group (Ferumoxytol/H2O2) and the standard of care (NaOCl) group. [Срок оценки: 1 Year]

Вторичные конечные точки (1)

• Periapical Bone Changes from Baseline in Periapical Radiographs at 6, 12, and 24 Months Follow Up [Срок оценки: 2 Years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Penn Dental Medicine, Department of Endodontics — Philadelphia

Публикации

• 1. Kakehashi S, Stanley HR, Fitzgerald RJ. The effects of surgical exposures of dental pulps in germ-free and conventional laboratory rats. Oral Surgery, Oral Medicine, Oral Pathology. 1965/09/01/ 1965;20(3):340-349. doi:https://doi.org/10.1016/0030-4220(65)90166-0 2. Bergenholtz G. Micro-organisms from necrotic pulp of traumatized teeth. Odontol Revy. 1974;25(4):347-58. 3. Kerekes K, Tronstad L.

Идентификаторы

NCT: NCT07518901 · 859377

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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