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临床试验/CTRI/2025/08/092926
CTRI/2025/08/092926尚未招募4 期

Comparative evaluation of the efficiency and patient perception towards conventional rubber dam and Insta dam for restoration of primary mandibular molars: A randomized clinical trial

Sejal Katariya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Time of placement

研究概览

简要总结

The oral cavity is a complex environment surrounded by hard and soft tissues. Most dental materials are hydrophobic, making moisture control essential for successful treatment. Challenges such as saliva, microorganisms, and limited control of the patient’s tongue and soft tissues make isolation difficult. Effective isolation improves treatment quality, safety, and longevity, while also preventing aspiration or ingestion of foreign objects. Rubber dam isolation was first introduced by Dr. Sanford Christie Barnum in 1869. Although its use declined in the early 20th century due to alternative methods and evolving dental practices, it remains a widely accepted and efficient isolation technique today, offering better visibility, moisture control, and a sterile field. Pediatric patients pose unique challenges for isolation due to limited cooperation. Common techniques include rubber dams, cotton rolls, saliva ejectors, gauze, and throat shields. While rubber dams are effective, traditional metal clamps can cause discomfort, soft-tissue injury, and anxiety in children.

So, a newer advancement known as Insta dam is there.

Insta-Dam is a frameless, foldable rubber dam that eliminates the need for a traditional frame. It offers full isolation with just a single hole punch, is more comfortable, reduces gag reflex, allows easy X-rays, and improves workflow. It enhances infection control, reduces microleakage, supports shade matching, and improves treatment outcomes.

Despite these advantages, limited research has focused on patient comfort, cooperation, and clinical efficiency of Insta-Dam in pediatric dentistry. Therefore, the current study aims to compare the efficiency and patient perception of Insta-Dam with conventional rubber dams in restoring primary mandibular molars in children aged 7-10 years.

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
7.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children who require Class 1 restoration in primary mandibular molar Fully erupted primary mandibular molar Simplified Oral Hygiene Index score of 0.5 Frankl’s behaviour ratings 3 and 4.

排除标准

  • Molars with any developmental anomalies Previously restored teeth Tooth where isolation is not possible Any clinical or radiographic evidence of proximal caries, periapical and periodontal pathology Special health-care needs Not willing.

结局指标

主要结局

Time of placement

时间窗: Evaluation will be done at baseline

次要结局

  • Isolation efficiency(Evaluation will be done at baseline)
  • Gingival health(Evaluation will be done at baseline)
  • Anxiety levels(Evaluation will be done at baseline)

研究者

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

SEJAL KATARIYA

Pacific dental college and hospital, Debari

研究点 (1)

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