跳至主要内容
临床试验/CTRI/2025/08/092710
CTRI/2025/08/092710Not Applicable4 期

Evaluation Of The Effectiveness of Enamel Deproteiniztion Prior To Etching On The Clinical Performance of Resin-Based Pit And Fissure Sealants In Primary Molars - A Randomized Controlled Trial.

Siddhi Lunawat1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
4 期
状态
Not Applicable
发起方
入组人数
70
试验地点
1
主要终点
Retention Rate

研究概览

简要总结

Dental caries remains one of the most prevalent chronic diseases affecting children worldwide, particularly in the primary dentition. The occlusal surfaces of primary molars, characterized by deep pits and fissures, are especially susceptible to carious lesions due to their complex morphology and the challenges they present in effective cleaning. As a preventive strategy, the application of pit and fissure sealants (PFS) has gained widespread acceptance for its ability to provide a physical barrier against cariogenic biofilm accumulation and acid attacks. Resin-based sealants, in particular, are preferred for their superior retention and sealing ability. However, the clinical success of these sealants depends heavily on the quality of adhesion to the enamel surface, which is influenced by several factors, including the condition of the enamel at the time of application.

One of the major impediments to optimal adhesion is the presence of an organic pellicle on the enamel surface. This proteinaceous layer, which includes salivary proteins and microbial products, can compromise the effectiveness of acid etching by preventing adequate penetration and demineralization of the enamel surface. Traditionally, acid etching with phosphoric acid has been employed to increase surface roughness and create microporosities for micromechanical retention. However, the presence of organic contaminants can hinder the etching process and reduce the sealant’s retention rate and longevity.

Enamel deproteinization is a pre-treatment technique that involves the use of agents such as sodium hypochlorite (NaOCl) to remove organic components from the enamel surface before acid etching. This step is believed to enhance the efficacy of the etching process by exposing more of the enamel’s mineral content, thereby improving resin tag formation and ultimately increasing bond strength. Several in vitro studies have demonstrated improved enamel surface morphology and enhanced bonding performance following deproteinization. However, there is limited high-quality clinical evidence to support the routine use of enamel deproteinization prior to sealant application, particularly in primary teeth, where enamel composition and structural differences may influence outcomes.

Given the potential benefits of enamel deproteinization, it is imperative to evaluate its effectiveness under clinical conditions. Primary molars, with their high caries susceptibility and relatively short lifespan, present a unique opportunity to assess preventive interventions in a meaningful timeframe. Additionally, children in the primary dentition phase may present behavioral management challenges that necessitate efficient and reliable treatment protocols. Therefore, techniques that enhance sealant retention and reduce the need for retreatment are of significant value in pediatric dentistry.

This study aims to evaluate the clinical performance of resin-based pit and fissure sealants in primary molars following enamel deproteinization prior to acid etching, using a randomized controlled trial design. The primary objective is to determine whether the additional step of enamel deproteinization improves sealant retention and reduces marginal discoloration and caries development over time. Secondary objectives include assessing the practicality of the procedure in a clinical pediatric setting and determining any potential adverse effects associated with the use of deproteinizing agents.

By providing robust clinical evidence through a well-designed randomized controlled trial, this research seeks to inform best practices for the application of pit and fissure sealants in young children. The findings may contribute to the development of more effective preventive protocols, ultimately improving oral health outcomes in the pediatric population. If enamel deproteinization proves beneficial, it could be incorporated into standard clinical procedures, thereby enhancing the long-term success of sealant therapy and reducing the burden of dental caries in children.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
3.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • 1.participants aged between #-7 years 2.participant to have atleast one first and/or second primary moalr 3.primary molars should be sound on all surfaces.

排除标准

  • 1.particiapnt unable to attend planned follow visits
  • non-motivated child/parent
  • unco-operative child.

结局指标

主要结局

Retention Rate

时间窗: Will Be Calculated Using Modified Simonsen’s criteria for sealant retention examination : | Score 0 : No loss of sealant and no evidence of caries | Score 1 : Partial loss of sealant and no evidence of caries | Score 2 : Partial loss of sealant and evidence of caries | Score 3 : Complete loss of sealant and no evidence of caries | Score 4 : Complete loss of sealant with caries evidence | it will be assessed at 3,6,9 and 12 month interval by visual method

次要结局

  • Secondary Caries(Will Be Checked By Radiographs)
  • Marginal Discolouration(Marginal discolouration will. be checked by Modified USPHS (United States Public Health Service) Criteria:)

研究者

发起方
Siddhi Lunawat
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr SIDDHI LUNAWAT

PACIFIC DENTAL COLLEGE AND HOSPITAL DEBARI

研究点 (1)

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