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临床试验/NCT06631885
NCT06631885尚未招募不适用

Efficacy of Integrated Nano-technology in the Irrigation Protocol of Revascularization Technique In Immature Necrotic Teeth (Randomized Clinical Trial)

Minia University0 个研究点目标入组 20 人开始时间: 2024年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
pain intensity assessed by numerical rating scale

研究概览

简要总结

This trial aims to study the effect of photoactivated disinfection using Diod laser (810 nm) to activate photosensitive nanoparticle chitosan as an endodontic irrigant versus sodium hypochlorite followed by saline and then EDTA 17% on 1) postoperative pain and 2) the success of revascularization in patients with necrotic immature maxillary anterior teeth using a randomized clinical trial design.

详细描述

randomized clinical trial will be conducted to investigate and compare the efficacy of photosensitized nano-chitosan 2% as an endodontic disinfectant during revascularization versus sodium hypochlorite, followed by EDTA 17% according to the standardized protocol of the American Association of endodontics.

Twenty individuals with necrotic, immature permanent anterior teeth will be recruited. They will be randomly assigned into two groups according to the received intervention: control group and test group.

pain will be evaluated as a primary outcome at 24 hours and one week post-intervention using numerical rating scale (NRS). In addition, the root development in terms of change in root length and apical foramen diameter and periapical bone healing will be evaluated as secondary outcomes using cone beam tomography.

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • o Immature necrotic maxillary incisor with open apex greater than 1 mm.
  • Teeth where pulp space are not needed for post and core.
  • A restorable tooth.
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • Patients who will agree to the consent and will commit to follow-up period.

排除标准

  • o Non-restorable teeth.
  • Teeth with root fractures, internal or external root resorption.
  • Teeth with mature fully developed root with closed apex
  • Patients with any systemic disease that may affect predictable outcome

结局指标

主要结局

pain intensity assessed by numerical rating scale

时间窗: 24 hours and 1 week after completion of the procedure

postoperative pain using numerical rating scale

次要结局

  • root development(6 months, 1 year postoperative)
  • Apical foramen closure(6 months, 1 year postoperative)
  • periapical bone healing(6 months, 1 year postoperative)

研究者

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

Mohammed abdelmawla mohammed

assisstant lecturer of endodontics

Minia University

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