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临床试验/NCT03554980
NCT03554980Unknown4 期

Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (A Randomized Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
46
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

The aim of this study is to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.

详细描述

Untreated dental decay and poor access to dental care are significant Public health problems for children in the world (Dye et al. 2015 and Horst, 2016). Early childhood caries is a multifactorial, infectious and transmissible dental disease affecting young children . Conventional restorative treatment may fail to reduce the burden of early childhood caries in many parts of the world. Most decayed teeth in preschool children remained unrestored . Consequences of untreated decay in preschool children may include increased risk of future caries in primary and permanent dentition, pain and infections; increased expensive emergency room visits and hospital admissions; increased treatment costs because of extensive decay and the accompanying need for general anesthesia; delayed growth and development; and missed days from school and work .To reduce the burden of caries disease in young children and to avoid possible serious consequences of untreated decay, it is important to identify an effective, low-cost method of treating caries in children at high risk of caries and with limited access to dental care. Silver diamine fluoride (SDF) has been identified as an anticariogenic agent that successfully arrests dental decay and has the potential to address the epidemic of untreated decay in young children

Therefore this study will be conducted to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.

Benefits of the research to the patient:

According to American Academy of Pediatric Dentistry (AAPD), 2017 SDF application is:

  • Safe.
  • Noninvasive.
  • Inexpensive.
  • Effective in dental caries management, especially arresting cavitated caries lesions in the primary dentition.

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)

盲法说明

Double (participant, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with carious primary teeth before eruption of permanent teeth
  • High caries risk patients with anterior or posterior carious lesions.
  • Uncooperative children without access to or with difficulty accessing dental care.

排除标准

  • Children with spontaneous or elicited pain from caries
  • Tooth mobility
  • Signs of pulpal infection
  • Severe medical conditions that would not allow management in the clinic
  • Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta
  • Known allergies or sensitivities to dental materials, including SDF
  • Inability to return for recall visits
  • Refusal of participation from the guardian or parents

研究组 & 干预措施

Group 1

Experimental

38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up at 0,1,3,6, 9 and 12.

SDF is a brush-on liquid.

干预措施: Silver Diamine Fluoride (Drug)

Group 2

Active Comparator

5% sodium fluoride varnish will be applied four times annually and patients will be followed up at 0,1,3,6,9 and 12.

干预措施: Sodium Fluoride varnish (Drug)

结局指标

主要结局

Postoperative Pain

时间窗: 12 months

Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)

次要结局

  • Discoloration (yellow, brown, black)(12 months)
  • Parental satisfaction(12 months)
  • Caries arrest (dentin texture) Cries arrest (Dentine texture)(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa A Salmoon, MSc

principal investigator

Cairo University

研究点 (1)

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