跳至主要内容
临床试验/CTRI/2025/12/098254
CTRI/2025/12/098254尚未招募2/3 期

Comparative Evaluation Of Ease Of Operator and Patient Acceptability While Using Three Different Isolation Systems In Children-A Clinical Trial

Dr. Anushka Manish Choche1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
To evaluate and compare the effectiveness of different isolation methods—cotton rolls, rubber dam,

研究概览

简要总结

Effective moisture control is crucial in pediatric dentistry to ensure the success of various dental procedures including restorative treatments, sealant application, bonding. salivary contamination can compromise the bonding efficiency, reduce the longevity of restorations, and increase the risk of secondary caries.1

Treating children often requires specialized techniques that differ from adult dental care. patients may have trouble staying still, following instructions, or tolerating certain procedures due to fear, discomfort. Additionally, the smaller size of their mouths poses challenges for effective isolation. As a result, the isolation method chosen must balance effectiveness with patient comfort.2

Generally traditional isolation is achieved using cotton roll and a mouth mirror, Rubber dam, suction devices. Cotton Roll is a simple, non-invasive method often preferred for children who are uncooperative or anxious. However, cotton rolls may not always provide the best moisture control, especially in more complex procedures. Rubber Damis considered the gold standard for isolation in many dental procedures, rubber dams offer superior moisture control but can be uncomfortable or difficult to apply in younger patients. Suction devices require active patient cooperation and may not fully control saliva from parotid and sublingual glands.3

Methods like rubber dams provide excellent moisture control but children show lot of discomfort when placed. Techniques like cotton rolls offer a more tolerable option but may lack the moisture control necessary for some procedures.

Recently introduced, Drydent sublingual and parotid Absorber have emerged as alternative isolation techniques that can efficiently absorb saliva while providing comfortable experience for pediatric patients, easy to place and remove improving clinical efficiency. These are placed directly over the open ducts of the salivary glands, where saliva production is most abundant. By absorbing saliva at this source, it effectively maintains a drier working area throughout dental treatments. Its soft, tissue-friendly design ensures patient comfort during use. Sublingual Absorber is designed to collect and control saliva produced by the sublingual and submandibular glands, this product offers an effective solution for managing moisture in the oral cavity. Its unique design ensures optimal moisture control during dental procedures.

However, there are no studies on the effectiveness of dry dent Absorber in patients and there is no comparative evaluation with currently used isolation methods.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Children age group between 4 and9 years
  • who had positive or definitely positive cooperation level according to the Frankl Behavior Rating Scale
  • Children with no history of previous restoration in the selected teeth.
  • Children without any systemic or mental disorders.
  • Molars indicated for class II restorations
  • Children with no known allergy to the materials used in the study.
  • Teeth with no signs of irreversible pulpitis, periodontally compromised teeth.
  • Patients who willfully give assent and for whom the parents or guardian will give the written informed consent to be part of this study.

排除标准

  • Teeth with deep carious lesions involving the pulp.
  • Presence of any systemic disorders.
  • 3.Special healthcare need children.
  • 4.Patients on medications affecting salivary flow 5.Patients with known allergy to latex of rubber dam.
  • 6.Patients who are not willing or for whom the parent or the guardian did not give the written informed consent for the treatment.

结局指标

主要结局

To evaluate and compare the effectiveness of different isolation methods—cotton rolls, rubber dam,

时间窗: comparing the effectiveness of different isolation methods during the restoration procedure

drydent sublingual and parotid Absorbers for the class II restoration of primary molars among

时间窗: comparing the effectiveness of different isolation methods during the restoration procedure

patient aged between 4to9 years

时间窗: comparing the effectiveness of different isolation methods during the restoration procedure

次要结局

  • patient comfort during the restoration(patient comfort during the restorative procedure)

研究者

发起方
Dr. Anushka Manish Choche
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR Anushka Manish Choche

Sri Siddhartha Dental College and Hospital,Tumkur

研究点 (1)

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