跳至主要内容
临床试验/CTRI/2024/08/072862
CTRI/2024/08/072862招募中4 期

To assess the effectiveness of silver diamine fluoride application with delayed glass ionomer cement restoration in dentinal caries of differently abled children An in-vivo study

Dr Shashwath K1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
72
试验地点
1
主要终点
Arrest of Progression of Caries

研究概览

简要总结

Dental caries continues to be one of the most prevalent chronic diseases in the world, affecting people across all age groups and countries . The oral health of differently abled children may be affected due to untreated dental conditions resulting from inadequate diagnosis or limited access to dental services . It’s acknowledged that differently abled children encounter distinct obstacles when pursuing preventive and restorative dental care . The presence of intricate physical and medical conditions, coupled with behavioural challenges, can complicate the process of diagnosis and treatment. Consequently, parents or caregivers face increased difficulty in fulfilling their role in providing daily preventive care .

The association between fluoride and dental practice, as well as preventive dentistry, spans over two centuries, as evidenced by historical documents indicating a potential correlation between fluoride and caries . Future studies are directed towards enhancing the antimicrobial and anti-degradative characteristics of existing restoration materials  by modifying their composition, with the goal of minimizing microbial adherence and biofilm formation .

Silver diamine fluoride, a solution comprising silver nitrate and fluoride, serves as both an antibacterial and remineralizing agent. By diminishing biofilm counts and impeding collagen degradation, the product promotes the remineralization of enamel and dentin, effectively halting the advancement of caries .

Silver diamine fluoride (SDF) plays a crucial role in caries management, particularly for children at high risk of caries, individuals with medical complexities, those facing behavioural challenges, and those encountering barriers to accessing dental care .

The mechanism of action of SDF relies in its ability to react with hydroxyapatite to generate fluorapatite, which prevents or lessens any future caries. When SDF is administered, it penetrates both the enamel and dentin, stocking the tooth with nearly twice as much subsurface fluoride as other fluoride forms . However, the primary drawback of SDF lies in its tendency to stain caries lesions, primarily attributable to the silver compounds present in the solution. This staining effect has contributed to the limited acceptance of SDF within the dental community .

The success and durability of dental restorations rely on various critical factors. Among them, establishing a robust bond between the restorative material and the tooth substrate is vital, encompassing not only mechanical considerations but also biological and aesthetic aspects . Chemical bonding to both enamel and dentin distinguishes glass ionomer cements (GICs) from others, by interactions involving hydroxyapatite and polycarboxylate radicals .

Applying GIC immediately following SDF application results in tooth discoloration, whereas delaying GIC restoration for two weeks after SDF application minimizes discoloration .

This study aims at assessing the effectiveness of SDF and GIC restoration in dentinal caries in differently abled children.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • 1.Differently abled children 2.Age between 3 -14 years will be selected
  • Selected subject should have dentinal caries involving either Primarymolars /Premolar/Permanent molars belonging to ICDAS score 4 and 5.

排除标准

  • 1.Enamel caries and caries involving pulp 2.Systemically healthy children with no physical and mental disabilities 3.Differently abled children less than 3 years and above 14 years.

结局指标

主要结局

Arrest of Progression of Caries

时间窗: 6 Months

次要结局

  • As a Control of Dental Caries Consequences in the Tooth(3 Years)

研究者

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

Dr Shashwath K

Coorg Institute of Dental Sciences

研究点 (1)

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