跳至主要内容
临床试验/CTRI/2024/06/069660
CTRI/2024/06/069660尚未招募2 期

Comparative evaluation of stainless steel and bioflx crowns in mandibular second primary molars :A randomized controlled trial

Nishi Rakesh Joshi1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年7月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Clinical and Radiographic Efficacy of Bioflx Crowns as Compared to Stainless Steel Crowns

研究概览

简要总结

With the continuous evolution of pediatric prosthodontics, aesthetics has emerged as a primary focus. Beyond anterior aesthetics, there is a growing demand for posterior aesthetics. To meet this demand, numerous innovations are underway for posterior aesthetic crowns. Validating these inventions requires dedicated research to compare them with existing conventional crowns.

As per the existing literature, the stainless steel crowns have been compared with other tooth colored restorations on the clinical parameters such as marginal integrity, crown retention, proximal contact, gingival and periodontal response color stability.

There is insufficient literature available regarding TMJ dysfunction, occlusion, opposing tooth wear on both stainless steel as well as Bioflx crowns. This emphasizes the importance of assessing occlusion and potential temporomandibular joint (TMJ) dysfunctions over time.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Endodontically treated mandibular primary second molar (pulpotomy /pulpectomy) requiring full coverage restoration.
  • 2.Healthy children with no systemic health disorders.
  • 3.Children, whose parents have provided consent.

排除标准

  • 1.Teeth with pathological root resorption , root caries and furcation involvement.
  • 2.Children with parafunctional habits and TMJ disorders.
  • 3.Teeth with inadequate tooth structure.

结局指标

主要结局

Clinical and Radiographic Efficacy of Bioflx Crowns as Compared to Stainless Steel Crowns

时间窗: 12 months

次要结局

  • Bioflx Crowns are biocompatible & non irritant to the Gingival tissue(12 months)

研究者

发起方
Nishi Rakesh Joshi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nishi Rakesh Joshi

AB Shetty Memorial Institute of Dental Sciences, NITTE Deemed To be University

研究点 (1)

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