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Dry-Shield vs Rubber Dam During Fissure Sealant Placement (DRY-SEAL)

2026年5月26日 更新者：Suez Canal University

Efficiency of Using Dry-Shield and Rubber Dam Isolation on Fissure Sealant Application in Permanent Molars: A Randomized Clinical Trial

This randomized clinical trial aims to evaluate the efficiency of the Dry-Shield isolation system compared with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars among pediatric patients.

The study evaluates chairside time, patient preference, and fissure sealant retention rates after 6 and 12 months of follow-up. Proper isolation during fissure sealant application is considered essential for optimal retention and long-term clinical success.

The study also aims to assess whether Dry-Shield can provide a practical and comfortable alternative to conventional isolation techniques in pediatric dentistry.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Fissure sealants are widely used preventive measures for reducing occlusal caries in permanent molars. Successful sealant retention largely depends on adequate moisture control during application. Rubber dam isolation has traditionally been considered the gold standard for moisture control; however, its use in pediatric dentistry may be associated with increased chair time and patient discomfort.

Dry-Shield is an isolation device that combines suction, tongue retraction, bite block support, and moisture control in a single system. This may improve clinical efficiency and patient comfort during dental procedures.

This randomized clinical trial compares the Dry-Shield isolation system with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars in children. The study evaluates clinical efficiency through assessment of chairside time, patient preference, and fissure sealant retention at 6 and 12month follow-ups.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 埃及
    • Ismailia Governorate
      • Ismailia、Ismailia Governorate、埃及、41522
        • Faculty of Dentistry, Suez Canal University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

Inclusion Criteria:

A- Patient inclusion criteria:

  1. Cooperative, apparently healthy children.
  2. Each child had at least three fully erupted first and/or second permanent molars.
  3. Patient being at high risk of dental caries.
  4. Informed consent was filled before treatment.

B- Molar inclusion criteria:

  1. Tooth had deep pits and fissures.
  2. Molars with the International Caries Detection and Assessment System (ICDAS) score 0-2.
  3. All three molars required PFS.

Exclusion Criteria:

A- Patient exclusion criteria:

  1. Uncooperative children.
  2. Children with special needs.
  3. Children who required emergency dental care (draining sinus, abscess and cellulitis).
  4. Who were suffering from an allergy to latex or a severe gag reflex.
  5. Mouth breather or child with nasal obstruction.
  6. Children with fixed orthodontic.

B- Molar exclusion criteria:

  1. Previous restored or carious first or second permanent molars.
  2. Molars with anomalies of the enamel or dentin.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Group 1: Dry-Shield Isolation
Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design.
其他：Pit and fissure sealant (Conseal F)
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
有源比较器：Group 2: Rubber Dam Isolation
Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design.
其他：Pit and fissure sealant (Conseal F)
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
有源比较器：Group 3: Cotton Roll Isolation
Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design
其他：Pit and fissure sealant (Conseal F)
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Sealant Retention Rate
大体时间：6 months and 12 months
Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.
6 months and 12 months

次要结果测量

结果测量
措施说明
大体时间
Chairside Time
大体时间：Immediately during procedure
Assessment of the time required for fissure sealant application using each isolation technique
Immediately during procedure
Patient Preference and discomfort
大体时间：Immediately after procedure
Assessment of patient preference and discomfort using a questionnaire and Wong-Baker FACES pain rating scale after fissure sealant placement
Immediately after procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Suez Canal University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月26日

初级完成 (实际的)

2026年4月29日

研究完成 (实际的)

2026年5月8日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SCU-PEDO-RCT-2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

To protect patient privacy and maintain confidentiality, individual participant data will not be made publicly available

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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