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临床试验/NCT02995369
NCT02995369已完成不适用

DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient

Montefiore Medical Center2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Patient Preference as Assessed by Verbal Self-report Survey

研究概览

简要总结

The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between Dryshield and the cotton roll technique.

详细描述

Pit and fissure caries account for 80 to 90 percent of all caries in permanent posterior teeth. Pit-and-fissure sealants can be used effectively to prevent caries. By micromechanically bonding to the teeth, they provide a physical barrier that keeps microorganisms and food particles from collecting in susceptible pits and fissures, thus preventing caries initiation and arresting caries progression. The effectiveness of sealants for caries prevention depends on long-term retention, which is largely a function of meticulousness of application: keeping the tooth surface free from saliva contamination during application and polymerization is critical. Low retention of sealants has been attributed to insufficient moisture control. Therefore, proper isolation of the teeth is one of the most important steps when placing sealants to ensure their retention. Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most common method among pediatric dentists. Although very effective, CRI can be a challenging technique especially when used in young children: the cotton rolls can be cumbersome for both the patient and the clinician. A previous study demonstrated that new moisture control systems such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block, but differs in that it's autoclavable and does not provide illumination. Its design allows it to suction and isolate half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement under a more controlled environment, while reducing chair time for the dentist.

The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between DryShield and the cotton roll technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
5 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist (ASA) Classification I or II
  • Ages 5 to 14 years
  • Cooperative behavior at present visit or recorded at the previous encounter (classified as 3 or 4 on the Frankl Behavioral Rating Scale).
  • At least one erupted caries-free permanent molar in each quadrant
  • Ability able to speak and understand English or Spanish
  • There will be no exclusions based on race, gender, and ethnicity.

排除标准

  • ASA Classification III or higher
  • Uncooperative behavior at present visit or recorded at the previous encounter (classified as 1 or 2 on the Frankl Behavioral Rating Scale).
  • Patients who require less than four sealants on permanent molars
  • Patients who do not provide assent or consent.

结局指标

主要结局

Patient Preference as Assessed by Verbal Self-report Survey

时间窗: Immediately after the dental procedure is completed, up to 30 minutes

Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence. Patient preferences were assessed with Question number 4, which specifically asked " If we did the procedure again, which system would you prefer?" The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.

Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)

时间窗: Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)

The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuntiya Kakanantadilok

Director Division of Pediatric Dentistry

Montefiore Medical Center

研究点 (2)

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