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临床试验/NCT07075055
NCT07075055招募中不适用

Impact of a New Bioceramic Based Intracanal Medication on Postoperative Pain and Periapical Healing

Minia University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
26
试验地点
1
主要终点
Treatment of Postoperative Pain

研究概览

简要总结

Periapical lesions are the commonly occurring pathologic lesions that affect the periradicular tissues of the tooth.This lesion can be classified as granuloma, cystic, or abscess .The pathological changes seen in some periradicular and periapical cases are due to the presence of microorganisms, and their byproducts.These released toxins have the ability to diffuse through inflamed pulpal tissue and get into the periapical area. In a necrotic pulp, the lack of blood flow in the root prevents host immunity from eliminating the infection.

详细描述

Endodontic treatment is essentially directed towards the prevention and control of pulpal and periradicular infections. Complete chemomechanical preparation may be considered an essential step in root canal disinfection. However total elimination of bacteria is difficult to accomplish. by remaining in the root canal between appointments, intracanal medicament may help to eliminate bacteria.

A medicament is an antimicrobial agent that is placed inside the root canal between treatment appointments in an attempt to destroy remaining microorganisms and prevent reinfection Thus, they may be utilized to kill bacteria, reduce inflammation (and thereby reduce pain), help eliminate apical exudate, control inflammatory root resorption and prevent contamination between appointments.When intracanal medicaments were not used between appointments, bacterial numbers increased rapidly.

The BIO-C® TEM has emerged as the first intracanal bioceramic medication of Endodontics, indicated for cases of treatment and retreatment due to its high pH to its antibacterial, bacteriostatic, anti- inflammatory and mineralization- -inducing action. Since it is a bioactive product, BIO-C® TEMP interacts with the surrounding tissue, stimulating healing. The tissue system responds to the material as if it was a natural tissue.

It has found its way in treatment of diverse cases: pulpitis, pulp necrosis, periapical lesion, persistent fistula, inflammatory or purulent exudate, perforation, apexification, external and internal resorption. It has been recommended not only for its actions, but also because it is a ready-to-use syringe, easy to insert into the root canal and with no painful symptomatology, even in cases where it has been extruded through the apical foramen.

Gradual release of Ca2+ Periodic exchange is not required, Biocompatible( Absence of symptomatology), High alkalinity (pH ~12)( Unsuitable environment for bacterial growth), Easy to remove( Clinical time optimization),and High radiopacity (Excellent radiographic visualization).

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with mature teeth.
  • •Patients with periapical periodontitis.
  • •Maxillary anterior teeth only will be involved.
  • •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

  • •Patients with immature roots.
  • •Patients with any systemic disease that may affect normal healing.
  • •Patients with swelling.
  • •Pregnant females.
  • •Patients who could/would not participate in a 1-year follow-up.
  • •Patients with old age.
  • •Teeth with periodontal involvement.
  • •Teeth with vertical root fractures.
  • •Non-restorable teeth.
  • •Cases with previously initiated endodontic treatment.

研究组 & 干预措施

Metapaste Calcium Hydroxide

Active Comparator

About 13 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Metapaste Calcium Hydroxide(Pre-mixed paste) as an intracanal medicament.

干预措施: Metapaste Calcium Hydroxide (Other)

Bio C-Temp

Active Comparator

About 13 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Bio C-Temp) as an intracanal medicament.

干预措施: Bio C-Temp (Other)

结局指标

主要结局

Treatment of Postoperative Pain

时间窗: from 0 hours to 2 weeks after the procedure

Patients will be evaluated for postoperative pain via (NRS) to record the intensity of pain.as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

次要结局

  • Periapical Healing(After 6 months to 12 months)

研究者

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

Hanaa Ewas Korany Mabrouk

Assistant lecturer of Endodontics at Nahda University,

Minia University

研究点 (1)

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