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临床试验/CTRI/2025/01/079575
CTRI/2025/01/079575招募中2 期

Development and Comparative evaluation of Novel Hydrophilic pit and fissure sealants added nanoparticles with Conventional Hydrophilic sealants for prevention of dental caries- An Experimental and Clinical trial

R Prabakar1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
45
试验地点
1
主要终点
change of color around the sealant, sealant retention, marginal adaptation, roughness of sealant surface, and fissure caries development

研究概览

简要总结

Dental caries is a multifactorial disease caused by alteration in the composition of the bacterial biofilm, leading to an imbalance between the demineralization and remineralization processes and manifested by the formation of caries lesions in primary and permanent dentitions.The results of the studies conducted in developing countries revealed that more than 80% of caries lesions in primary and permanent teeth required restorative treatment.

There are two primary clinical preventive strategies for reducing the risk of dental caries: topical fluoride application and fissure sealant application. Topical fluoride application is a more effective method on smooth tooth surfaces, while pit and fissure sealants are used successfully on the occlusal tooth surface.

Three main types of materials are available as pit and fissure sealants: glass ionomer cements, compomers and resins. Though glass ionomer cements as well as resin modified glass ionomer cements exhibit excellent Fluoride release and cariostatic properties, it is not widely used in clinical practice owing to its poor retention rates.

Advanced moisture-tolerant resin-based sealant technology has been developed that performs well with and benefits from the persistent moisture in the mouth, allowing sealants to be placed on slightly moist teeth even during the early eruption. Some of the commercially available hydrophilic sealants are Embrace WetBond, Ultraseal XT hydro.

Furthermore , novel sealants incorporating nanotechnology have been developed and are gaining popularity in the field of dental research due to their physicochemical and biological properties, including biocompatibility, size, charge, large surface area, strength, solubility, chemical and surface reactivity, color, high stability, and thermal conductivity. As dentists are constantly faced with the challenges of existing pit and fissure sealants, there is a dire need to explore newer materials that can help overcome these drawbacks ultimately contributing to a healthy oral cavity.

Hence this study was undertaken with the aim of comparing the clinical effectiveness of a formulated hydrophilic nano sealant with a commercially available hydrophilic sealant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
10.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 1.Bilateral mandibular first permanent molars which were fully erupted 2.Deep pits and fissures are present in these permanent molars (ICDAS II code 00).
  • 3.Initial occlusal carious lesions involving the pits and fissures of enamel (ICDAS II code 01).

排除标准

  • Patients who were medically compromised, children with developmental defects/hypoplastic molars or caries affected teeth, teeth with restorations or partially retained sealant restorations, and partially erupted teeth were excluded.

结局指标

主要结局

change of color around the sealant, sealant retention, marginal adaptation, roughness of sealant surface, and fissure caries development

时间窗: At Baseline, 1 month, 3 months and 6 months

次要结局

未报告次要终点

研究者

发起方
R Prabakar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jayashriprabakar

Saveetha Dental College

研究点 (1)

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