Evaluation of the Antibacterial Effect of Nano Silver Fluoride Versus Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bacterial Count of Streptococus Mutans
研究概览
简要总结
- The teeth of the patients that meet inclusion criteria will be anesthetized, isolated with a rubber dam.
- Cavity opened using conventional high-speed rotary instruments.
- The central cariogenic biomass and the superficial parts of the necrotic dentine will be removed with round burs.
- Caries lesion will be completely removed in the enamel/dentin junction.
- The excavation procedure will be terminated as soon as the soft and wet dentine was removed and the remaining tissue was leathery but not hard on exploring.
- A dentinal sample will then be collected from the base of the cavity using sterile spoon excavator as a baseline for bacteriological assessment.
- Then, application of either intervention or control agent, another dentinal sample will be collected using a sterile excavator and transferred into sterile tubes and transferred to the laboratory for microbiological analysis.
- Filling of the cavity with resin composite restoration.
- All clinical procedures will be carried out at the same visit.
详细描述
I.1. Study setting This clinical study will be held in the Clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt. The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them.
II.4.a Excavation protocol:
The teeth of the patients that meet inclusion criteria will be anesthetized, isolated with a rubber dam. Cavity opened using conventional high-speed rotary instruments. The central cariogenic biomass and the superficial parts of the necrotic dentine will be removed with round burs. Caries lesion will be completely removed in the enamel/dentin junction. The excavation procedure will be terminated as soon as the soft and wet dentine was removed and the remaining tissue was leathery but not hard on exploring. A dentinal sample will then be collected from the base of the cavity using sterile spoon excavator as a baseline for bacteriological assessment. Then, application of either intervention or control agent, another dentinal sample will be collected using a sterile excavator and transferred into sterile tubes and transferred to the laboratory for microbiological analysis.
II.4.b Assessment of Outcome:
Samples of carious dentine will be collected with sterile excavator before and after application of intervention/control agent. The dentine samples will be transferred to sterile container containing a 1mL thioglycollate medium used as a carrier, then this sterile container will be kept in an ice box and taken to the microbiology laboratory for processing, within an hour, by another examiner who is blinded to the type of agent applied after partial caries removal. Samples will be vortexed for two minutes, decimally diluted and 0.1 ml will be plated on Mitis Salivarius Bacitracin agar plates, these plates will be incubated anaerobically for 48 hour at 37ºC then aerobically for 24 hour at room temperature. The number of colonies will be expressed as colony-forming units (CFU/ml) compared before and after application of the antibacterial agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria of participants:
- •Not received antibiotic therapy since 1 month before sampling.
- •Good oral hygiene.
- •Co-operative patients approving the trial.
- •Inclusion Criteria of teeth:
- •Class I deep caries lesions in permanent molar (reaching ≥ 1/2 of the dentin on radiographic examination).
- •Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).
排除标准
- •Exclusion criteria of participants:
- •Systemic disease or severe medical complications.
- •Heavy smoking.
- •Xerostomia.
- •Lack of compliance.
- •Exclusion criteria of teeth:
- •Class II caries lesion.
- •Shallow or enamel caries.
- •Cuspal loss or caries beneath the gingival margin.
研究组 & 干预措施
Cavity Cleanser
Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.
干预措施: Cavity Cleanser (Drug)
Nano silver fluoride solution
Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.
干预措施: Nano silver fluoride solution (Drug)
结局指标
主要结局
Bacterial Count of Streptococus Mutans
时间窗: 5 minutes on average between baseline and after application of the solution
Digital Colony Counter, Agar Diffusion test
次要结局
未报告次要终点
研究者
ali mostafa shamaa
Principle Investigator, Dentist at Suez health directorate
Cairo University