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临床试验/CTRI/2021/06/033976
CTRI/2021/06/033976尚未招募不适用

comparative evaluation of three root canal obturating materials for primary teeth namely- metapex, metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride: an in vivo study

SGT University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Comparative evaluation of three root canal obturating materials for primary teeth namely- Metapex, Metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride.

研究概览

简要总结

Properties of an ideal root canal filling material should be: antibacterial, resorbs at the same rate as the root, not causing any harm to periapical tissues, fluid tight seal along the length of canal, resorb if extruded beyond apex, adhere to the canal wall, radiopaque in radiograph, do not cause any discoloration to the tooth. Another commercially available iodoform based materials are: walkhoffâ€s paste, kri paste, maisto paste and metapex.(11)Metapex is another successful root canal material. It is a known bactericidal that suppresses any residual bacteria in the canal or periapcal region. It doesn’t show toxic effects on permanent successor and is radiopaque. However, conventional metapex does not have adequate handling properties and have tendency to extrude beyond the apex due to its viscosity.(12)Zinc oxide eugenol is widely used primary tooth obturating material. However, Zinc oxide eugenol has certain disadvantages, that is slow resorption and irritation to periapical tissues.(13)  10% sodium fluoride was added to zinc oxide powder to overcome these disadvantages.The resorption rate of the material was seen to be same as physiological root resorption.Iodoform based material like metapex have tendency to extrude beyond apex due to low viscosity. Thus, there was need to add an agent to increase the viscosity of the metapex, which would decrease the extrusion of obturating material periapically to give desired consistency. Absorbable gelatin sponge (AGS) is an absorbable material and appropriate to fulfil our purpose.Metapex manipulated with minced particles ofabsorbable gelatin sponge maintained the viscosity of the paste and was suggested as novel approach for obturation in primary teeth.(12)As Zinc oxide eugenol is gold standard obturating material, but because of its few shortcomings, combination of Zinc oxide powder with fluoride is being introduced. Further to improve Metapex, Metapex manipulated with minced particles of absorbable gelatin sponge is also being introduced. We are carrying out a comparison among (i) Metapex (ii) metapex with absorbable gelatin sponge and (iii) zinc oxide powder with 10% sodium fluoride to access the quality of obturation in primary teeth.Thus, in the present study we will evaluate the efficacy of three obturating materials i.e., metapex, metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • •1.Children of age group 4-8 years.
  • •2.Tooth indicted for pulpectomy.

排除标准

  • •1.Children with any systemic disease 2.Medically compromised children.

结局指标

主要结局

Comparative evaluation of three root canal obturating materials for primary teeth namely- Metapex, Metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride.

时间窗: Patients will be examined clinically at 3,6,9 and 12 month and radiographically at 6 and 12 months

次要结局

  • 1. To evaluate clinical and radiographic success rate of metapex with absorbable gelatin sponge.(2. To evaluate clinical and radiographic success rate of zinc oxide powder with 10% sodium fluoride.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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