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临床试验/NCT05300152
NCT05300152已完成不适用

A Comparative Evaluation of Pulpal Response to ACTIVA BioACTIVE Versus Mineral Trioxide Aggregate (MTA) As a Vital Pulpotomy Medications in Primary Teeth: an in Vivo Study

Suez Canal University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月2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
30
试验地点
1
主要终点
the regenerative effect of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth

研究概览

简要总结

this study is aimed to evaluate and compare the pulp response to ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth.

详细描述

Pulpotomy is an endodontic technique that involves amputating the coronal pulp and covering the residual root pulp with a clinically effective pulp medicament that is bactericidal, capable of forming a biological barrier and allows the physiological root resorption until primary tooth exfoliation. In primary dentition, pulpotomy therapy is divided into three types based on the treatment goals: devitalization (mummification), preservation, and regeneration. Formocresol is the benchmark for pulpotomy treatment in primary teeth. Buckley first used it to treat nonvital permanent teeth in 1904, and it later became a common pulpotomy medication for primary teeth primarily because of its superior clinical success and simplicity of use . However, toxicity, mutagenicity, and carcinogenicity issues posed by the possible systemic spreading of FC molecules via the root canals raised concerns on its use ; as a result, a more biocompatible, nontoxic medication was required.

Biocompatible and bioactive materials containing calcium silicate have become increasingly common in paediatric dentistry in recent years because of their properties, which include stimulation of pulp cell regeneration, re - routing of the inflammatory response, and improving the healing ability of the remaining vital pulp . Mineral trioxide aggregate (MTA) was developed and implemented as a root-end filling at Loma Linda University in California, USA, in 1993; its physical and chemical properties were identified by Torabinejad et al ., in 1995. MTA is a chemical compound composed of tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium sulphate dehydrate, gypsum, and bismuth oxide . It hydrates to form a colloidal gel with a pH of 12.5, equivalent to that of calcium hydroxide . Moreover, it takes 3 to 4 hours to set with a compressive strength of 70 Mpa after setting, which is comparable to Intermediate Restorative Material (IRM) . MTA is a biocompatible substance that seals better than amalgam or zinc oxide eugenol (ZOE) [30-32] also, it retains pulp vitality and induces repair as it comes into contact with dental pulp or peri-radicular tissues. MTA has been thoroughly examined clinically and radiologically, as well as compared to other pulpotomy medicaments, and it has been reported that MTA should be considered the new gold standard for pulp-capping therapy. On the other hand, MTA has some drawbacks, including difficulty in manipulation, a long setting duration, a high cost, poor mechanical properties, poor adhesion to dental tissue and tooth staining .

Several recent calcium silicate-based materials have been developed in order to alleviate MTA's drawbacks. ACTIVA BioACTIVE Base/Liner, a BioACTIVE glass-incorporated light-curable pulp capping material, was recently introduced in 2014 as a "light-cured resin-modified calcium silicate" (RMCS) claiming composite's resilience, aesthetics, and physical properties, as well as improved calcium, phosphate, and fluoride release when compared to glass ionomer . It comprised of a diurethane and methacrylate-based monomer with a modified polyacrylic acid and polybutadiene-modified diurethane dimethacrylate as well as BioACTIVE glass as a filler . ACTIVA has three setting reactions: it cures with low intensity light for 20 seconds per layer and has both glass-ionomer (acid-base reaction) and composite self-cure setting reactions. The bioactivity of ACTIVA BioACTIVE products is dependent on a process in which the material reacts to pH cycles and actively participates in the release and recharging of considerable amounts of calcium, phosphate, and fluoride . Theses mineral components are concerned with promoting the development of mineralized hard tissue also, they promote the creation of a connective apatite layer and the development of a seal at the material-tooth interface .

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
7 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy & cooperative child
  • •No history of spontaneous pain
  • •No pathologic tooth mobility
  • •Normal gingival and periodontal condition
  • •Absence of furcal/periapical radiolucency

排除标准

  • •Uncooperativeness of child and/or parents
  • •Unrestorable tooth
  • •history of spontaneous pain
  • •Percussion sensitivity

研究组 & 干预措施

ACTIVA BioACTIVE Base/Liner

Experimental

is a BioACTIVE glass-incorporated light-curable pulp capping material also known as light-cured resin-modified calcium silicate

干预措施: Immunohistochemistry Protocol for Fibronectin Antibody (Diagnostic Test)

ACTIVA BioACTIVE Base/Liner

Experimental

is a BioACTIVE glass-incorporated light-curable pulp capping material also known as light-cured resin-modified calcium silicate

干预措施: Immunohistochemistry Protocol for Osteopontin Antibody (Diagnostic Test)

ACTIVA BioACTIVE Base/Liner

Experimental

is a BioACTIVE glass-incorporated light-curable pulp capping material also known as light-cured resin-modified calcium silicate

干预措施: pulpotomy procedure and Histological evaluation (Procedure)

Mineral trioxide aggregate (MTA)

Active Comparator

is a bioactive materials containing calcium silicate

干预措施: pulpotomy procedure and Histological evaluation (Procedure)

Mineral trioxide aggregate (MTA)

Active Comparator

is a bioactive materials containing calcium silicate

干预措施: Immunohistochemistry Protocol for Fibronectin Antibody (Diagnostic Test)

Mineral trioxide aggregate (MTA)

Active Comparator

is a bioactive materials containing calcium silicate

干预措施: Immunohistochemistry Protocol for Osteopontin Antibody (Diagnostic Test)

结局指标

主要结局

the regenerative effect of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth

时间窗: 12 months

by assessment of reparative dentin formation in the histological sections of the tested teeth by detection of the presence of odontoblast cells (dentin forming- cells) and mineralized tissue between the capping material and the remaining pulp tissue.

次要结局

  • the reparative dentinogenesis process after application of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth(12 months)

研究者

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

shaimaa shaban mohamed el-desouky

Lecturer of Pediatric dentistry

Suez Canal University

研究点 (1)

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