跳至主要内容
临床试验/CTRI/2025/07/090381
CTRI/2025/07/090381尚未招募Unknown

Comparative evaluation of clinical and radiographic success of bioflx crowns and stainless steel crowns in primary molars: a split mouth randomized clinical trial.

Dr N Sushanth Billava1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Percentage of clinical success and radiographic success of Bioflx crowns and stainless steel crowns.

研究概览

简要总结

NEED FOR STUDY

Dental caries in children is a serious public health issue. It is now equally important to do different restorative procedures on the deciduous dentition in order to preserve their function and aesthetics. Due to rising awareness aesthetics is becoming more and more important in pediatric dentistry these days. There is a driving demand for quick, minimally invasive, and aesthetic restorations in pediatric dentistry. For full coverage restorations, stainless steel crowns continue to be the gold standard even after being introduced decades back. Their strength, retention, and conservative tooth preparation are the benefits, however their primary drawback being unesthetic. Zirconia crowns are thought to be the most aesthetically pleasing choice for treating primary molars. These crowns have a high level of polish and are tooth-coloured. The drawbacks of these crowns are their high cost, considerable dental preparation, and inability to be altered and they abrade the opposing tooth. The first flexible, long- lasting, and aesthetically pleasing prefabricated crown for primary molars is the Bioflx Crown, which is manufactured by Kids-e-Dental since 2021. The medical device industry uses Bioflx materials. Bioflx crowns are tooth coloured, monochromatic, metal-free, and composed of a high-strength resin polymer that is highly durable, flexible, and strong. These crowns can be autoclaved and tooth preparation is similar to stainless steel crowns. Thus, there is a need to assess clinically the gingival health and oral hygiene condition of teeth restored with Bioflx crowns and stainless steel crowns. Keeping in mind the paucity of studies, this study aims to evaluate the clinical and radiographic success and patient/parental satisfaction with Bioflx crowns in comparison to stainless steel crowns in primary molars.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy, co–operative participants (Frankl’s positive and definitely positive) aged 6 to 9 years with primary molars treated with pulp therapy (IPC, Pulpotomy, Pulpectomy) or with multi-surface carious lesions bilaterally.
  • Restorable primary molars functioning in occlusion with an opposing tooth, and possessing at least one contact area with an adjacent tooth.

排除标准

  • Inappropriately obturated primary molars.
  • Tooth with internal resorption or tooth with more than one third of root resorption.
  • Patients with very poor oral hygiene and DMFT or dmft score greater than
  • Patients with known allergy to local anesthesia, chromium, nickel and resin material.
  • Patients with bruxism and other parafunctional habits.

结局指标

主要结局

Percentage of clinical success and radiographic success of Bioflx crowns and stainless steel crowns.

时间窗: 12 months.

次要结局

  • Plaque scores and gingival health around the Bioflx crowns and stainless steel(crowns.)
  • Patient and parental satisfaction with Bioflx crowns and Stainless steel crowns.(12 months.)

研究者

发起方
Dr N Sushanth Billava
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr N Sushanth Billava

Government dental college and research institute, Bangalore

研究点 (1)

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