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临床试验/NCT05723133
NCT05723133招募中不适用

A Randomized Controlled Trial Comparing Manual Versus Powered Toothbrushes With Visual Feedback

University Ghent8 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
8
主要终点
Oral hygiene with or without visual feedback

研究概览

简要总结

The goal of this clinical trial is to learn about the influence of providing visual feedback on brushing technique and habits on oral health of patients undergoing periodontal treatment.

The main question[s] it aims to answer are:

  • Is patients' oral health improved by providing visual feedback on their brushing technique using the smartphone brushing app?

  • Is there behavioural change of patients based on this daily visual feedback? Participants will receive oral hygiene instructions after initial periodontal treatment and will be randomized in group 1, 2 or 3. Participants will be asked to

  • fulfill a brushing diary with the time of brushing every day.

  • come back for a check-up appointment every 3 weeks during the study to evaluate oral hygiene.

Researchers will compare manual toothbrush, electric toothbrush without daily personal feedback and electric toothbrush with daily personal feedback to see if visual feedback provide improved oral health

详细描述

Periodontitis is gum disease with jawbone deterioration. Diagnosis is based on clinical examination: plaque score, pocket measurement (measuring the pockets or gum pockets around the teeth with a probe), gingival bleeding index (= bleeding after probing) and radiographic examination. Smoking, genetic factors, and systemic diseases such as diabetes, for example, are known risk factors for this condition. Treatment consists of a deep cleaning, where the tooth roots are freed of plaque and tartar under local anaesthesia, complemented by the necessary oral hygiene instructions. It is important that patients follow these oral hygiene instructions carefully at home and perform them daily, as the aim is to achieve optimal oral hygiene. Good oral hygiene is fundamental in the treatment of periodontitis (Arweiler et al, 2018).

Despite many patients undergoing the proposed professional treatment (deep cleaning), they are often insufficiently able to remove the dental plaque present on a daily basis. To optimise brushing efficiency, both behavioural change and improved brushing technique should be obtained at the patient level.

The primary aim of this randomised clinical trial is to improve patients' oral health by providing visual feedback on their brushing technique using the smartphone brushing app. The secondary aim of the study is to investigate possible behavioural changes of patients based on this daily visual feedback.

Patients requiring periodontal treatment will be recruited at the Department of Periodontology & Oral Implantology at Ghent University Hospital. Patients will be assigned to three groups by randomisation. In group 1, patients will receive oral hygiene instructions and a new manual toothbrush. In group 2, patients receive the same oral hygiene instructions and a basic electric toothbrush without daily personal feedback using the brushing application. In group 3, patients receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app). No raw study data will be transferred to Oral B. The only data that will be available to Oral-B is the data that will be included in the publication of this study (A1 article). The use of the app does not require registration of personal data. Brushing time, tooth surface cleaning and brushing pressure will be recorded. Patients will only complete the brushing time in the brushing diary.

Oral hygiene will be evaluated at the start and every 3 weeks during the study through a check-up appointment. Only the first (after 3 weeks) and the last check-up appointment (after 12 weeks) are standard protocol, the remaining appointments (after 6 and 9 weeks) are study-specific. Oral hygiene will be assessed by: plaque score, gingival bleeding index, brushing frequency and brushing duration. The full study will take 12 weeks. Pocket depth will be measured according to usual protocols, namely at intake and at the last check-up (after 12 weeks). The patient's brushing technique and frequency will be recorded through a brushing diary completed by the patient. Where necessary, oral hygiene can be adjusted during each sitting. The check-up after 3 weeks and 12 weeks with measurement of plaque scores, gingival bleeding index and pocket depth are part of the standard protocol for treating periodontitis and are therefore not study-specific. Monitoring after 6 and 9 weeks are study-specific. The primary goal will be evaluated by comparing plaque scores and gingival bleeding index at intake with those at the final check. The secondary goal will be evaluated by brushing frequency and brushing duration throughout the study course. All data collected will be pseudonymised.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The patient and treating dentist cannot be masked. The investigators and outcome assessors are masked

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in need of periodontal treatment
  • Willing to keep a brushing diary
  • Possess a smartphone so that they are able to install and handle the application on their phone

排除标准

  • Systemic disease
  • Pregnancy

结局指标

主要结局

Oral hygiene with or without visual feedback

时间窗: 12 weeks

Comparing the plaque scores at intake with those at final check-up

次要结局

  • Behavioural changes(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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