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临床试验/NCT04905784
NCT04905784Unknown不适用

The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children: A Single-blind Randomized Controlled Clinical Trial

University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
2
主要终点
Oral hygiene - dental plaque

研究概览

简要总结

This randomized clinical trial study aims to investigate the impact of home-based differential learning on tooth brushing, in particular on the reduction of plaque and maintenance of gingival health in children aged 3 to 8 years, compared to the habitual tooth brushing and instruction/demonstration tooth brushing learning method.

详细描述

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. The examination of the patient will be undertaken in a dental chair set up using standard infection control guidelines for a dental examination used at the department. The allocation of the patients to the two groups will be done through asking the patients to pick up an envelope randomly from a box which contains the information and explanation for home brushing.

In the first visit, the baseline dental examination and patient acceptance survey will be done to comprehensively assess each participant's oral health status, their oral hygiene status, caries experience and periodontal condition will be recorded.

To assess oral hygiene status we will use plaque index (PI) (Quigley Hein, 1972) on a scale of 0 to 5. Dental caries experience will be recorded by counting the numbers of teeth that are decayed (dt/DT), missing due to caries (mt/MT), and filled (ft/FT) to generate a dmft/DMFT score. Periodontal condition will be recorded using the papillary bleeding index Index (PBI) on a scale of 0 to 4. One trained and calibrated examiner will perform the clinical examinations.

The study and its objectives will be explained to the patients. For the control group, regular instructions and advice will be provided as in any regular prophylaxis session.

For the test group, the exercises and movements to be performed when brushing the teeth will be explained. The patients in both groups will be also provided with explanation leaflet with the exercises and a free toothbrush. There will be no restriction on the type of the fluoridated toothpaste.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

The information and instructions for the two groups will be placed in 70 envelopes, each group has 35 envelopes, and then these envelopes will be mixed randomly (as in playing cards) and at the end these envelopes will be placed in a box. Patients will be asked to randomly select an envelope from the box. The investigator assesses oral hygiene in check-up appointments without knowledge of group allocation.

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged 3 - 8 years.
  • •Need for parental assistance with tooth brushing.
  • •Need for check-up/ prophylaxis appointment approx. 4 and 12 weeks.

排除标准

  • •Patients with pain/ patients with signs or symptoms to be treated.
  • •Patients with systemic disease that require special attention during their dental treatment.
  • •Parents / children who refuse to participate in the study.

研究组 & 干预措施

Control group: Usual brushing.

Active Comparator

Usual motivation to brush teeth in the clinic (KAI brushing technique) in addition to brushing teeth by the parents.

干预措施: Usual toothbrushing (Behavioral)

Test group: Differential learning group.

Experimental

Use of differential learning of tooth brushing at home, including children and parents.

干预措施: Differential learning (Behavioral)

结局指标

主要结局

Oral hygiene - dental plaque

时间窗: 3 months

Plaque index (QHI: Quigley-Hein plaque index)

Oral hygiene - gingivitis

时间窗: 3 months

Gingival bleeding index (PBI: papilla bleeding index)

Oral hygiene - dental plaque

时间窗: 1 month

Plaque index (QHI: Quigley-Hein plaque index)

Oral hygiene - gingivitis

时间窗: 1 month

Gingival bleeding index (PBI: papilla bleeding index)

次要结局

  • Parental acceptance (mid-term)(3 months)
  • Parental acceptance(1 month)

研究者

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

研究点 (2)

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