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临床试验/NCT05445362
NCT05445362已完成不适用

Evaluation of the Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps: A Preliminary Randomized Controlled Trial

Reham Hassan1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
The change in root length evaluation

研究概览

简要总结

Recruited patients with immature permanent maxillary anterior teeth with non-vital pulp, and periapical radiolucency, age ranging from 8 to16 years old were randomly allocated into three groups (n=13): Group I, disinfected using the triple antibiotic paste, Group II, disinfection was done using diode laser, and Group III, were disinfected using the triple antibiotic paste, diode laser was used for biostimulation. All groups were evaluated for the increase in root length and thickness and decrease in apical diameter at baseline, 3, 6, 9, and 12 months after treatment

详细描述

  • The investigator recruited patients who are found eligible to the criteria then randomly allocated into three groups (n=13)
  • Group I: thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the blood clot method.
  • Group II: thirteen teeth were Laser disinfected; revascularization was done using the the blood clot method.
  • Group III: thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the the blood clot method followed by diode laser bio-stimulation.
  • periapical x rays was taken at baseline, 3, 6, 9, and 12 months after treatment for the increase in root length and thickness, decrease in apical diameter evaluation

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Medically free patients.
  • Immature permanent maxillary anterior teeth.
  • Non vital pulp.
  • patents age between 8-16 years.
  • Both sexes.
  • Restorable teeth.
  • No internal or external root resorption.
  • No horizontal or vertical root fracture
  • Radiographic periapical radiolucency
  • No history of previous endodontic treatment of the tooth.

排除标准

  • Medically compromised patients
  • Previous endodontic therapy of the affected tooth.
  • Teeth diagnosed with vital pulp.
  • Teeth with periodontal pocket more than 3mm deep.
  • Teeth with caries below the bony level (non-restorable tooth).
  • Mature teeth with complete apices.

研究组 & 干预措施

Group I

Active Comparator

Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.

干预措施: Triple antibiotic paste disinfection (Drug)

Group I

Active Comparator

Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method.

干预措施: revascularization using the standard method "Blood Clot" (Procedure)

Group II

Active Comparator

Thirteen teeth were Laser disinfected; revascularization was done using the standard method.

干预措施: Diode laser disinfection (Device)

Group II

Active Comparator

Thirteen teeth were Laser disinfected; revascularization was done using the standard method.

干预措施: revascularization using the standard method "Blood Clot" (Procedure)

Group III

Active Comparator

Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.

干预措施: Diode Laser bio-stimulation. (Device)

Group III

Active Comparator

Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.

干预措施: Triple antibiotic paste disinfection (Drug)

Group III

Active Comparator

Thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the standard method followed by diode laser bio-stimulation.

干预措施: revascularization using the standard method "Blood Clot" (Procedure)

结局指标

主要结局

The change in root length evaluation

时间窗: at baseline, 3, 6, 9, and 12 months after treatment

Numerical using Image-J analysis software for radiographs standardization and measuring in mm, the percentage of change in length will be calculated by subtracting the 12 m length from the baseline , 3, 6, 9 months lengths divided by the baseline, 3, 6, 9 months length multiplying the value by 100 - post length - pre length / pre length x 100

次要结局

  • The change in root thickness(At base line , 3, 6, 9, and 12 month after treatment)
  • The change in apical diameter(At base line, 3, 6, 9, and 12 month after treatment)

研究者

发起方
Reham Hassan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Reham Hassan

Assoc. Prof. Dr Reham Hassan

Minia University

研究点 (1)

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