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临床试验/NCT07427615
NCT07427615已完成不适用

Regenerative Endodontics of Immature Teeth in Multiple Visits Versus Single Visit Using LASER Activation Irrigation Technique

Ahmed Ibrahim Salim1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Clinical Success Rate at 12 Months

研究概览

简要总结

This randomized clinical trial evaluated the clinical and radiographic outcomes of regenerative endodontic procedures performed using different irrigation activation protocols in immature permanent maxillary anterior teeth. Thirty patients were randomly assigned into three groups according to the use of laser-activated irrigation and number of visits. Clinical and cone beam computed tomographic (CBCT) outcomes were assessed over a 12-month follow-up period.

详细描述

Thirty patients aged 9-25 years with non-vital immature permanent maxillary anterior teeth were included. Patients were randomly allocated into three equal groups based on the irrigation activation technique and number of visits. Regenerative endodontic procedures were performed following standardized protocols. Clinical evaluations were conducted at multiple follow-up intervals, while radiographic assessments using CBCT were performed at baseline, 6, and 12 months to evaluate root development and periapical healing.

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
Single (Outcomes Assessor)

入排标准

年龄范围
9 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Non-vital immature permanent maxillary anterior teeth due to trauma or caries
  • Incomplete root formation with apical foramen > 1 mm
  • Medically healthy patients

排除标准

  • Allergy to medications used in the study Teeth requiring post and core restorations Periodontal pockets > 4 mm Apical foramen < 1 mm Periapical radiolucency > 10 mm Internal or external root resorption History of major systemic surgeries (e.g., cardiac surgery, kidney transplantation, hemodialysis)

研究组 & 干预措施

Regenerative endodontic procedures (REPs) without laser activation

Active Comparator

Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation without laser activation.

干预措施: Laser-Activated Irrigation (Procedure)

Regenerative endodontic procedures (REPs) with laser activation (two visits)

Experimental

Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation with 810-nm diode laser activation.

干预措施: Regenerative Endodontic Procedure (Procedure)

Regenerative endodontic procedures (REPs) without laser activation

Active Comparator

Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation without laser activation.

干预措施: Regenerative Endodontic Procedure (Procedure)

Regenerative endodontic procedures (REPs) with laser activation (two visits)

Experimental

Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation with 810-nm diode laser activation.

干预措施: Laser-Activated Irrigation (Procedure)

Regenerative endodontic procedures (REPs) with laser activation (single visit)

Experimental

Regenerative endodontic procedures completed in a single visit using sodium hypochlorite irrigation with 810-nm diode laser activation.

干预措施: Regenerative Endodontic Procedure (Procedure)

结局指标

主要结局

Clinical Success Rate at 12 Months

时间窗: 12 months

Clinical success defined as the absence of pain, tenderness to percussion, swelling, or sinus tract, assessed through standardized clinical examination. The outcome will be reported as the number and percentage of treated teeth demonstrating clinical success.

次要结局

  • Change in Root Length Measured by CBCT(Baseline, 6 months, 12 months)
  • Change in Root Canal Width Measured by CBCT(Baseline, 6 months, 12 months)
  • Change in Apical Diameter Measured by CBCT(Baseline, 6 months, 12 months)
  • Change in Periapical Lesion Size Measured by CBCT(Baseline, 6 months, 12 months)

研究者

发起方
Ahmed Ibrahim Salim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Ibrahim Salim

Assistant Lecturer of Endodontics

Tanta University

研究点 (1)

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