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临床试验/NCT06006052
NCT06006052招募中不适用

Evaluation of Demineralized Dentin Matrix as a Scaffold for Revascularization in Immature Permanent Incisors: A Randomized Controlled Trial and an In -Vitro Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11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
入组人数
30
试验地点
1
主要终点
the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month

研究概览

简要总结

Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in vivo).

Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs) (in vitro).

详细描述

Necrosis of the immature pulp not only is one of the multiple factors affecting long-term tooth endurance and preservation but also can act as a source of bacterial infection in the periapical area and even the maxillofacial spaces

  • The use of regenerative endodontic techniques (RET) have gained popularity in the past decade with several endodontic and pediatric dentistry organization recognizing this technique as a viable technique for immature permanent teeth with necrotic pulps Regenerative endodontics are defined as biologically based techniques planned to physiologically replace impaired tooth structure, including dentin and root constructions, as well as cells of the pulp-dentin complex
  • They offer the benefit of root lengthening, thickening, and subsequent apical closure which is not achievable with conventional nonsurgical endodontic treatment (NSET). The success rate of the blood clot (RET) in immature teeth has been reported to be 97.8% .The American Association of Endodontists and the European Society of Endodontology developed evidence-based protocols. To help reduce some of the differences in the RET steps such as EDTA ethylene diamine tetra acetic acid and sodium hypochlorite use, however, variations in terms of intracanal medicament, scaffold, and assessment tools still exist due to the lack of high-quality evidence

A fundamental component of the regenerative endodontic process is the presence of a scaffold for stem cells from the apical papilla to adhere, multiply and differentiate. Based on the results of many studies, the use of blood clot Regenerative procedure is not considered a true scaffold system. But it is an essential part of any appropriately designed tissue engineering regenerative endodontic strategy

.

Different treatment options and scaffolds have been tested in regenerative endodontics. Only

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •patients clinical examination Must be include the following
  • •Patients aged 7-13years at the time of enrolment.
  • •Provision of informed consent by one parent or legal guardian.
  • •At least the patents have one immature permanent anterior tooth diagnosed with irreversible pulpitis or pulp necrosis with or without periapical lesions.
  • •Restorable teeth ,clinical crown should be enough to use rapper dam Compliant patient/parent.
  • •Patients are not allergic to medicaments and antibiotics necessary to complete the procedure (ASA 1 or 2).
  • •Radiologic evidence of open apices (Teeth are considered immature when a minimum of 0.8 mm apical foramen width is evident)

排除标准

  • •the patients will excluded if one of the following criteria is present in the patients
  • •Teeth with root fractures.
  • •Presence of internal or external root resorptions.
  • •Developmental anomalies of the root.
  • •Presence of periapical radiolucency more than 10 mm.
  • •Tooth with class III mobility.

研究组 & 干预措施

study group DDM

Experimental

Group I: 10 teeth will be treated with demineralized dentin matrix attached to collagen membrane as a scaffold in the regenerative endodontic procedure.

干预措施: regeneration technique (Combination Product)

Control group

Active Comparator

Group II: 10 teeth will be treated with the conventional regenerative endodontic procedure (blood clot scaffold).

干预措施: regeneration technique (Combination Product)

positive control

Active Comparator

Group III: 10 teeth will be treated with collage membrane as a scaffold in the regenerative endodontic procedure

干预措施: regeneration technique (Combination Product)

结局指标

主要结局

the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month

时间窗: at 0,3 and 6 and 9and 12 month

no history of pain, using Visual Analog Score for pain, measure quality of life. soft tissue swelling or sinus tract by visual examination , Sensitivity to percussion, Tooth mobility by clinical assessment by operator

次要结局

  • change root wall thickness and root length in radiographic measurement in millimeter at 0,3,6,9,12 month(at 0, 3 and 6 and 9and 12 month)

研究者

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

Marwa Ahmed Abozed mahmoud

Assistant Lecturer

Ain Shams University

研究点 (1)

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