跳至主要内容
临床试验/CTRI/2024/06/068620
CTRI/2024/06/068620尚未招募Phase 3 4

Clinical evaluation of the effectiveness of Zinc Oxide nanoparticles-containing cavity disinfectant on the retention of restorations in carious primary molars

JSS Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年6月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
To evaluate and compare the effect of zinc oxide nanoparticles containing cavity disinfectant with that of commercially available chlorhexidine gel on retention of the restorations using FDI clinical scoring criteria

研究概览

简要总结

Dental caries is a common oral health problem in children characterized by the destruction of tooth structures at various levels. With the advent of minimally invasive techniques, bacteria in the affected carious tissue are still left behind after removing infected tissue.Microgaps around the restorations can form at margins due to polymerization shrinkage and chewing pressures.This could promote bacterial growth, particularly S. mutans, under the restoration, causing secondary caries and reducing longevity of the restoration. Thus, to overcome this, the concept of cavity disinfectants was introduced. Disinfecting the cavity after caries removal helps prevent recurrent caries, post-procedure sensitivity, and restoration failure. Several studies have reported using chlorhexidine, sodium hypochlorite, and silver, zinc, and titanium nanoparticles as cavity disinfectants. Nanoparticles are small size particles ranging from 1 to 100 nm. They exhibit efficient antibacterial properties, protect adhesives from degradation, prevent caries, inhibit biofilm formation and maturation, and promote remineralization. Among various metals that are being modified and incorporated in combination with oxide, zinc is known for its biocompatibility antibacterial effects. According to US-FDA, zinc oxide is considered as generally recognized as safe (GRAS) substance. Zinc oxide nanoparticles (ZnONPs) are chosen for their minimal cytotoxicity in human cells and as antibacterial even at low concentrations. In vitro studies confirm that ZnO NP cavity disinfectants outperform alternatives in antibacterial efficacy without compromising restoration bonding strength. The purpose of the study is to evaluate the efficacy of the zinc oxide nanoparticles - containing cavity disinfectant as an alternative to commercially available ones, with effective antimicrobial activity and unpertubed retention of the restorations placed over the cavity.

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
6.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Children included- 1.within age of 6-9 years with presence of caries in any primary 1st and 2nd molar
  • moderately deep cavities (ICDAS II caries score 4,5,6) limited to single-surface occlusal lesions 3.systemically healthy and cooperative children (Frankl scale 3 and 4) Radiographic criteria: 1.Children with caries involving enamel, dentin and with at least remaining dentin thickness of at least 0.5mm.

排除标准

  • Children with- 1.intellectual disability 2.systemic illness and on long term medication 3.presence of root stumps in oral cavity 4.presence of open carious lesions in oral cavity 5.with any known allergy 6.buccal/lingual extension.

结局指标

主要结局

To evaluate and compare the effect of zinc oxide nanoparticles containing cavity disinfectant with that of commercially available chlorhexidine gel on retention of the restorations using FDI clinical scoring criteria

时间窗: assessed at baseline, 3 months, and 6 months

次要结局

  • 1.To evaluate & compare the antimicrobial activity of zinc oxide nanoparticles with that of commercially available chlorhexidine gel as a cavity disinfectant in the prepared cavity by using microbial plating.(2.To evaluate & compare the ultrastructure of dentin tubules after disinfection with a zinc oxide-incorporated disinfectant & chlorhexidine on sectioned teeth through scanning electron microscopy (in vitro).)

研究者

发起方
JSS Dental College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Abhinaya Ananthakumar

JSS Dental College and Hospital

研究点 (1)

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