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临床试验/NCT05098483
NCT05098483已完成不适用

Clinical and Radiographic Evaluation of Regenerative Endodontics Using MTA and Biodentine for Non-vital Primary Molars Compared to Conventional Root Canal Treatment. (A Randomized Controlled Clinical Trial)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Radiographic measures

研究概览

简要总结

Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold

详细描述

Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups:

Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months

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
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Non-vital mandibular primary second molar.
  • •Restorable tooth

排除标准

  • •Patients allergic to medicaments or antibiotics necessary to complete the procedure.
  • •Special Health Care Needs
  • •Excessive mobility
  • •Presence of internal or external root resorption.

研究组 & 干预措施

Conventional root canal treatment

Active Comparator

The caries will be removed. An excavator will be used to remove the coronal portion of the dental pulp while the radicular portion will be cleaned using k- files. 2.5% Sodium hypochlorite will be used as irrigant solution.The canals will be filled with ZOE cement and a stainless-steel crown will be inserted to restore the tooth.

干预措施: Conventional Root canal treatment in primary molars (Procedure)

Regenerative endodontic treatment using MTA

Experimental

Access cavity will be prepared in each primary molar then each canal will be copiously irrigated by sodium hypochlorite. Triple antibiotic paste will be inserted in eash canal then sealed with temporary restoration till the second visit.

In the second visit canals will be irrigated with EDTA, after that induction of bleeding will be created by overinstumentation inside each canal. Finally sealed with MTA under the GIC restoration and S.S.C

干预措施: Regeneration in primary molars by using MTA (Procedure)

Regenerative endodontic treatment using Biodentine

Experimental

Access cavity will be prepared in each primary molar then canals will be copiously irrigated by sodium hypochlorite. Mixture of Triple antibiotic paste will be introduced in eash canal then cavity will be sealed with temporary restoration till the second visit.

In the second visit canals will be irrigated with EDTA, after that bleeding will be created by overinstumentation inside each canal. Finally sealed with biodentine under the GIC restoration and S.S.C

干预措施: Regeneration in primary molars by using biodentine (Procedure)

结局指标

主要结局

Radiographic measures

时间窗: 12 months

39 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome

Clinical measures

时间窗: 12 months

39 children with no pain or swelling (i.e) successful outcomes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Hasaballah

Principal investigator

Ain Shams University

研究点 (1)

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