Clinical effectiveness and cost-effectiveness of two sodium fluoride varnish systems in preventing dental caries in children: a randomized clinical trial

Q1 Medicine

Journal of oral biology and craniofacial research Pub Date : 2026-01-01 Epub Date: 2025-12-02 DOI:10.1016/j.jobcr.2025.11.018

Mahesh R. Khairnar , P.G. Naveen Kumar , Harloveen Sabharwal , Sachin Kumar Jadhav , Sheetal Badnaware , Neha Shukla , Ananta Kusumakar , Zainab Akram , Savitha Priyadarsini S , Ridhi Ghodela

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引用次数: 0

Abstract

Background

Dental caries frequently affects first permanent molars soon after eruption due to their anatomical susceptibility. Fluoride varnish is a widely accepted preventive measure; however, different formulations vary in fluoride retention and cost. Evidence comparing both clinical outcomes and economic value of available varnishes in children remains limited.

Aim

To compare the clinical effectiveness and cost-effectiveness of resin-based and alcohol-based 5 % sodium fluoride varnishes in preventing dental caries in permanent first molars of high-risk schoolchildren.

Design

A double-blind, parallel-arm randomized controlled trial was conducted among 84 children (330 M) aged 6–8 years from a private school in Varanasi, India. Participants received either resin-based varnish (163 teeth) or alcohol-based varnish (167 teeth) at six-month intervals. Caries incidence was assessed at baseline, 6, 12, 18, and 24 months using ICDAS-II. A financial cost-benefit perspective was adopted, considering direct material and application costs borne by the provider and estimated restorative treatment savings for patients. Appropriate statistical tests were used for analysis (α = 0.05).

Results

Caries incidence remained low in both groups after 24 months (resin-based: 7.4 %; alcohol-based: 7.8 %; p = 0.961). No significant differences were found in early or advanced lesions at any interval (p > 0.05). ITT and Per-protocol analyses revealed negligible effect sizes (Cliff's Delta ≤0.05). Cost-effectiveness analysis demonstrated that the alcohol-based varnish produced ₹62.22 savings per ₹1 spent, compared to ₹8.47 in resin-based group. The cost to save ₹100 in future restorative expenses was ₹1.61 (alcohol-based) and ₹11.80 (resin-based).

Conclusion

Both varnishes were equally effective, but alcohol-based varnish was substantially more cost-effective, making it a suitable choice for large-scale preventive programs in resource-constrained settings.

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两种氟化钠清漆系统预防儿童龋齿的临床效果和成本效益：一项随机临床试验

由于第一恒磨牙在解剖学上的易感性，龋齿经常在出牙后不久发生。氟化物清漆是一种广泛接受的预防措施；然而，不同的配方在氟化物保留和成本方面有所不同。比较儿童可用清漆的临床结果和经济价值的证据仍然有限。目的比较树脂基和醇基5%氟化钠清漆预防高危学童恒牙第一磨牙龋病的临床效果和成本效益。设计对印度瓦拉纳西一所私立学校的84名6-8岁儿童（330名）进行了双盲、平行组随机对照试验。参与者每六个月接受一次树脂基清漆（163颗牙齿）或酒精基清漆（167颗牙齿）。使用ICDAS-II评估基线、6、12、18和24个月的龋发病率。采用财务成本-效益的观点，考虑由提供者承担的直接材料和应用成本以及估计患者的恢复性治疗节省。采用适当的统计学检验进行分析（α = 0.05）。结果24个月后，两组患者的惊恐发生率均较低（树脂基：7.4%；酒精基：7.8%;p = 0.961）。早期和晚期病变在任何间隔均无显著差异（p > 0.05）。ITT和Per-protocol分析显示效应大小可以忽略不计（Cliff’s Delta≤0.05）。成本效益分析表明，醇基清漆每花费1卢比节省62.22卢比，而树脂基组为8.47卢比。在未来修复费用中节省100卢比的成本为1.61卢比（酒精基）和11.80卢比（树脂基）。结论两种清漆的效果相同，但醇基清漆的成本效益更高，是资源紧张地区大规模预防项目的合适选择。

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来源期刊

Journal of oral biology and craniofacial research Medicine-Otorhinolaryngology

CiteScore

4.90

自引率

0.00%

发文量

133

审稿时长

167 days

期刊介绍： Journal of Oral Biology and Craniofacial Research (JOBCR)is the official journal of the Craniofacial Research Foundation (CRF). The journal aims to provide a common platform for both clinical and translational research and to promote interdisciplinary sciences in craniofacial region. JOBCR publishes content that includes diseases, injuries and defects in the head, neck, face, jaws and the hard and soft tissues of the mouth and jaws and face region; diagnosis and medical management of diseases specific to the orofacial tissues and of oral manifestations of systemic diseases; studies on identifying populations at risk of oral disease or in need of specific care, and comparing regional, environmental, social, and access similarities and differences in dental care between populations; diseases of the mouth and related structures like salivary glands, temporomandibular joints, facial muscles and perioral skin; biomedical engineering, tissue engineering and stem cells. The journal publishes reviews, commentaries, peer-reviewed original research articles, short communication, and case reports.