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临床试验/CTRI/2024/10/075418
CTRI/2024/10/075418尚未招募3 期

Comprehensive evaluation of potassium iodide added silver diamine fluoride and silver fluoride in stage-II Early childhood caries- A clinical trial

Dr Revanuru Swathi1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
To clinically evaluate and compare the tooth discoloration caused by 38% SDF added potassium iodide and 38% AgF added potassium iodide.

研究概览

简要总结

Early Childhood Caries (ECC) is used to denote the occurrence of one or more primary teeth, in a child under the age of 6, that are decayed, restored, or missing. ECC has 4 stages, wherein any failure to address the initial reversible lesion will progress to the traumatic stage. In the traumatic stage of ECC, the teeth become so weak by caries that they fracture on minor trauma. Hence importance has to be given for the early reversal of the lesion and its arrest. ECC when left untreated results in pain, irritability, bacteremia, high treatment costs, reduced growth and development, speech disorders, and premature tooth loss with its sequelae of compromised chewing, loss of self-esteem, and permanent dentition hampering their mental attitude. 44% of children aged between 8 and 48 months have ECC in India. According to McDonald and Avery, the major three steps in preventing ECC are decreasing substrate concentration, decreasing microbial load, and increasing resistance of the tooth.6 Traditionally, the approach to managing carious lesions involves mechanical removal of the decayed tissue and replacing it with an appropriate restorative material. The treatment success with traditional approaches is highly influenced by the child’s behavior in the dental setting. As an alternative Minimal invasive dentistry (MID), which aims at maintenance of the sound tooth structure using non-invasive techniques has replaced the conventional procedures. Carol Anne et al, say that the “minimally invasive” approach to treating dental caries incorporates the dental science of detecting, diagnosing, intercepting, and treating dental caries on the microscopic level. ART, PRR, and SMART are among the many nonsurgical methods used in this approach to treating dental caries.SDF adheres to the philosophy of minimally invasive dentistry. Stebbins utilized SDF for the first time in 1969, and Japan approved it in August 2014 for therapeutic usage. SDF contains silver which is bactericidal and is used as an antimicrobial agent to arrest caries. It can be utilized extensively in pediatric dentistry since it is non-invasive, especially for children with unique healthcare needs and recalcitrant behavior, where traditional treatments can be technique-sensitive. It acts by obstructing dentinal tubules, promoting demineralized teeth to become more mineralized, and preventing the breakdown of dentinal collagen. The primary disadvantages of silver diamine therapy are the black stain left by the silver content and the strong taste and odor of ammonia, which also slightly irritates soft tissues. Studies were done on the effects of varying concentrations of silver diamine fluoride in arresting dental caries, but there is a dearth of information on how to prevent the tooth structure from discoloration after a procedure, cover up the smell, and lessen pain in the soft tissues. To prevent discoloration, our study applies potassium iodide (KI) after applying 38% silver fluoride with water as a solvent to overcome the soft tissue discomfort caused by ammonia. Thus this study aims to compare conventional 38% SDF added potassium iodide with 38% AgF added potassium iodide with water as a solvent.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Active carious lesions which have ICDAS code
  • Teeth selected as per ICCMS score 2 to
  • Children who meet the Lampshire classification for cooperation. Children with parental consent.

排除标准

  • Children with spontaneous pain or any signs of pulpal infection.
  • Children having any clinical or radiographic signs of periapical infection.
  • Active carious lesions which have ICDAS codes 5 and
  • Children who have sensitivity to silver or other heavy metal ions.

结局指标

主要结局

To clinically evaluate and compare the tooth discoloration caused by 38% SDF added potassium iodide and 38% AgF added potassium iodide.

时间窗: Baseline, 6 months

次要结局

  • To clinically and radiographically evaluate and compare the caries progression with 38% SDF added potassium iodide and 38% AgF added potassium iodide.(To clinically evaluate and compare the duration of application of both the materials.)

研究者

发起方
Dr Revanuru Swathi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Revanuru Swathi

K V G Dental college and hospital

研究点 (1)

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