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临床试验/NCT05612451
NCT05612451进行中(未招募)不适用

Outcome of Regenerative Endodontic Procedures for Necrotic Immature Permanent Teeth, Using Two Different Protocols: A Prospective Randomized Clinical Study.

King Abdullah University Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
45
试验地点
2
主要终点
treatment success

研究概览

简要总结

Clinical management of immature non-vital (necrotic) permanent teeth is challenging, due to inherent structural weakness. Earlier management of such teeth relied on the traditional calcium hydroxide (Ca(OH)2) apexification procedure or the application of apical barriers However, neither procedure allows for promoting root dentin maturation. In 2004, a novel management technique for treating immature, non-vital teeth called regenerative endodontic procedures (REP; also known as revascularization) was introduced. This procedure allowed for continued root maturation presented in an increase in root length and dentin wall thickness. The key points of REP include minimal or no instrumentation of the dentinal walls, disinfection with irrigant solutions and intracanal medicaments, provocation of bleeding into the canal space for creation of a blood clot, capping with calcium silicate-based material, and an effective coronal seal to prevent reinfection of the root canal system. Several case reports and clinical studies reported promising results for REP treatment. However, studies widely varied in their treatment methods, hence the search for an optimal REP protocol is still ongoing. A recent review reported that the methodological quality of REP clinical trials available to date, was low with a moderate to high risk of bias. To date, only few studies evaluated the outcome of REPs based on different types of intracanal medicaments. These studies either presented a retrospective design, low sample size and/or short follow up period. Hence, the need for randomized, controlled clinical studies to provide persuasive evidence on the efficacy of different intracanal medicaments in REP is of utmost importance. The aim of this study is to prospectively assess and compare the clinical and radiographic outcomes of REP in non-vital immature permanent teeth using an intracanal medicament modified TAP or non-setting Ca(OH)2 paste. Forty-five patients yielding a total of 50 anterior and posterior non-vital immature teeth were randomly divided into 2 groups. REP utilizing either non-setting calcium hydroxide (Ca(OH)2) (n=25) or modified triple antibiotic paste (TAP) (n=25), as intracanal medicaments were performed. NeoMTA Plus was applied for coronal sealing. Cases were followed up clinically and radiographically for 24 months. Survival rate, success rate, and clinical outcome measures were analyzed.

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
7 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Anterior or posterior tooth diagnosed with necrotic pulp (as a result of trauma, caries or anomaly) in the presence or absence of apical periodontitis.
  • an immature apex or open apex(an apical diameter wider than 1 mm and is radiographically visible)
  • Pulp space not needed for post and core restoration
  • A cooperative and Compliant patient/ parent
  • Patients not allergic to medicaments necessary to complete the procedure.

排除标准

  • medically compromised patient,
  • teeth with vertical fractures,
  • periodontally involved teeth,
  • non-restorable teeth,
  • teeth when bleeding could not be induced.

结局指标

主要结局

treatment success

时间窗: 36 months

disappearance of clinical signs and symptoms including tenderness to percussion or palpation, a swelling or sinus tract, or spontaneous pain, and absence or reduction in the size of periapiacl radiolucency

次要结局

  • root maturation(36 months)
  • root elongation(36 months)
  • root completion(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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