跳至主要内容
临床试验/CTRI/2023/09/057884
CTRI/2023/09/057884已完成不适用

Efficacy of silver diamine fluoride versus silver diamine fluoride & fluoride varnish in arresting dental caries in special children

School of dental sciences, Sharda University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年9月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Clinical evidence of dental decay arrest. Conversion of Nyvad scale 1, 2, and 3 to 4, 5, 6.

研究概览

简要总结

Dental caries has beenaround for time immemorial. It is a microbial infectious disease and probablythe most significant chronic childhood disease prevalent globally. It can leadto a high level of morbidity and affect the quality of life in many ways. It isa secular infectious disease cutting across all sections of society in bothdeveloped and developing nations. Some of the consequences of untreated lesionsare pain, swelling, fever, inability to eat, malnutrition, difficulty in speechand tooth loss.

A lot has changed inthe recent past in understanding the science of dental caries, its preventionand treatment but data from across the world shows that dental caries remains aserious disease globally.

The level of awarenessin caregivers (parents and non dental healthcare providers) regarding thesymptoms, treatment (especially of untreated lesions) and prevention of dentalcaries remains low. This leads to a huge burden of care on the society.

Special health careneeds children are at a much higher risk of developing dental caries because oftheir inherent challenges of carrying our even simple acts like tooth brushing.Added to this is also the fact that most of the parents of special children maybe focused on seeking and providing seemingly more important medical care totheir child/children which leads to a neglect of dental care. Medical care inspecial children may also involve administering medications in a sweetenedsyrup form which are mostly sugar based. Lack of awareness regarding cariesprevention amongst parents leads to dental caries in such children. Specialchildren are often on pureed diets which are more cariogenic and need specialpreventive protocols often found missing. Added to these is the fact thatspecial children need a different approach for their dental treatment and hencenot all dentists are able to competently treat special children. More oftenthan not this also entails higher treatment costs which become a constraint formany parents leading to a neglect of dental caries. This may become a viciouscycle and end in serious morbidity and tooth loss.

Over time numerouspreventive strategies and protocols have been tried and tested by the dentalfraternity of researchers and clinicians. Literature is replete with manyexamples and two stand out in recent times. These are topical application offluoride varnish (FV) and silver diamine fluoride (SDF). Many studies have beenconducted on both the protocols and there are meta analysis and systematicreviews too, explaining the evidence on their efficacy. Both protocols work.

Traditionally fluoride varnish has beenextensively used in the prevention of dental caries. SDF has proven itself tobe a effective measure in arresting decay, hence the interest in its use inspecial children. Very few relevant studies exist in the literature where inSDF has been studied in special children, either alone or with fluoridevarnish.

This trial will try and bridge this gap.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • Special children aged 4 years to 14 years with dental decay will be selected.

排除标准

  • Special children below 4years and above 14 years and those with no dental decay will be excluded.

结局指标

主要结局

Clinical evidence of dental decay arrest. Conversion of Nyvad scale 1, 2, and 3 to 4, 5, 6.

时间窗: Clinical evidence of dental decay arrest. Conversion of Nyvad scale 1, 2, and 3 to 4, 5, 6.

次要结局

  • Clinical evidence of non arrest of dental decay. Any clinical evidence of worsening of the existing dental decay in terms of pain/abcess(6 months, 12 months, 18 months.)

研究者

发起方
School of dental sciences, Sharda University
申办方类型
Other [Private dental college and hospital]

研究点 (1)

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