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临床试验/NCT05285228
NCT05285228已完成不适用

Motivational Effect of Choosing the Taste of te Fluoride Varnish on Acceptance and Behavior During Dental Visit in Children - a Single Blind RCT

University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
acceptance of dental treatment

研究概览

简要总结

To assess the influence of the choice of fluoride varnish flavor on the acceptance and cooperation in schoolchildren between (5-10) years during the dental visit, in which an application of fluoride varnish is indicated.

详细描述

The main assumption of the study is giving the child the option to choose e.g. their preferred taste of the fluoride varnish possibly moves the focus away from not being willing to receive the fluoride varnish application to rather accepting it (pseudoalternative).

The aim of this study is to investigate the impact of participation via choosing the taste of the fluoride varnish (locus of control and pseudo-alternative) on the acceptance and cooperation during dental visit in schoolchildren aged 5 to 10 years.

This two-parallel arm single-blind randomized controlled clinical trial will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald from approximately January 2022 to Autumn 2022. The child will be randomly allocated using simple random sampling with the use of random table method, in which 35 randomly generated serial numbers for each group will be generated by Windows Microsoft Excel (2010, USA) to ensure equal randomization of each group.

The test group will receive a previously allocated flavor of fluoride varnish (Profluorid VOCO, Germany) ranging from (Melon, Caramel, Cherry, Bubble gum, Mint) containing 22,500 ppm fluoride. However the test group will be receiving the choosing the taste of the previously mentioned fluoride varnish r with flavor ranging from (Melon, Caramel, Cherry, Bubble gum, Mint). After allocation an independent observer enters the dental treatment room for blinded assessment. After the dental visit, the participating child, the accompanying parent or caregiver, the dental operator and the blinded assessor receive a short questionnaire to be filled out.

Patients presenting with acute pain or with signs and symptoms, which should be treated will not be asked to participate. Moreover Systemic diseases that require special attention during their dental treatment or Parents/children who refused to participate in the study, and reported allergy against ingredients of the toothpaste are excluded from participation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessor enters the room to observe the dental treatment after the allocation to the group when the fluoride varnish is placed ready.

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged between 5 - 10 years.
  • •Clinical presentation due to a dental appointment, in which an application of fluoride varnish is planned.

排除标准

  • •Patients presented with acute pain/ patients with signs or symptoms to be treated.
  • •Patients reported with systemic diseases that require special attention during their dental treatment.
  • •Parents or children, who refuse participation in the study.
  • •Reported Allergy against ingredients of the toothpaste or the fluoride varnish.

研究组 & 干预措施

Control group: allocation to specific taste of fluoride varnish

Active Comparator

allocation to specific taste of fluoride varnish

干预措施: given fluoride varnish (control) (Behavioral)

Test group: child chooses taste of fluoride varnish

Experimental

child chooses taste of fluoride varnish before dental treatment

干预措施: effect of choice on cooperation (pseudoalternative) (Behavioral)

结局指标

主要结局

acceptance of dental treatment

时间窗: assessment during the dental visit via independent observer; usually the dental visit does not exceed more than 30 minutes; the overall behavior is rated during this time period

measurement via Frankl behavioral scale;

次要结局

  • acceptance of taste of fluoride varnish(assessment right after the end dental visit by the child; immediately, this means within about 1 minute after the application of the varnish)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (1)

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