The Effect of An Artificial Intelligence ("AI") Mobile Dental Application ("Dental Monitoring") in the Promotion of Self-Administered Plaque Control: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Full Mouth Bleeding Score (%)
研究概览
简要总结
Randomized Controlled Trial: to investigate the feasibility of the usage of a mobile dental application in the self-administration of plaque control in a two (2) parallel arm study with 52 subjects (n = 52). The study will take place over 2 visits (within 35 days): Visit 1 and 2.
Prospective Open Cohort Study: Patients referred to the Periodontology Department will be invited to participate in the study during the Oral Hygiene Phase. Routine clinical indices will be recorded at Visit 1 and Visit 2 before active non-surgical periodontal treatment commences.
详细描述
Visit 1 (Week 0, Day 0): Start of Study
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Subjects: The periodontal patients who have a dental appointment scheduled in the National University Centre for Oral Health, Singapore and fulfil inclusion/exclusion criteria will be recruited into the study by the delegated study team members. After written informed consent has been obtained and all the standard dental practices such as collecting the Routine Clinical Periodontal Parameters for evaluation and providing Oral Hygiene Instruction are done by the blinded study team member(s) termed as the Examiner. After which, the Participants will be randomized into 2 groups by delegated study team members.
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There will be two groups:
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Test (n = 26): Dental Monitoring ("DM") Kit + 2-month DM subscription
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Control (n = 26): No DM Kit
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The Examiner will be either the Co-investigator or an oral hygiene therapist engaged to be on the delegated study team. The same single blinded Examiner will examine all the participants of the study at both Visits 1 and 2.
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Based on the design of the study, there will be no deviation from the standard periodontal treatment protocol and intervals between treatment for this group of patients in the public healthcare setting with the exception for the test groups whereby the usage of an additional DM application which will be evaluated in this study.
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The Test group will receive DM as an additional monitoring aid. The delegated study team members will guide the Test group to download the DM application onto their mobile device, provide them with a DM Kit including full instructions (verbal and instruction pamphlet).
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In addition, the Test group will be taught by the delegated study team members:
- How to pair up a DM Scanbox with your smartphone https://youtu.be/y-q9Z8JMbzo
- How to perform DM Scans with ScanBox https://youtu.be/YT859VMGL18
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The Test group will be required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members:
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Day 0 (To be taken at the clinic)
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Day 7 (To be taken in the evening after brushing teeth)
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Day 14 (To be taken in the evening after brushing teeth)
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Day 21(To be taken in the evening after brushing teeth)
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Day 28 (To be taken before study Visit 2) *There is a window period of +1 day for the intra-oral videos.
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The Control group will monitor their own oral hygiene without any additional aids.
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All patients will be given a soft-bristled toothbrush, fluoridated toothpaste and inter-dental aids by the delegated study team members. They will be instructed not to use any forms of mouth rinse.
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)
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 21 and 65 years old
- •Dentate patients
- •English speaking and literacy for verbal instructions including the usage of the DM application
- •Have access or own a smartphone with wifi and/or cellular connectivity
- •Ability to provide informed consent to participate in the study and willing to download the DM application onto their smartphone
- •Able to link and register their email account to receive notifications from DM application during the study
排除标准
- •Patients below 21 years old
- •Patients who is in dental pain
- •Patients with dementia
- •Patients who has compromised manual dexterity
- •Patients who had received Scaling and Polishing less than one month prior to examination and treatment
- •Pregnant or lactating women
结局指标
主要结局
Full Mouth Bleeding Score (%)
时间窗: Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Difference in Full Mouth Bleeding Score using a UNC periodontal probe, 6 surfaces per tooth (mesio-buccal, mid buccal, disco-buccal, mesio-lingual, mid-lingual and ditto-lingual) will be measured
Full Mouth Plaque Score (%)
时间窗: Between Visit 1 (Day 0) and Visit 2 (between Day 28 and 35)
Difference in Full Mouth Plaque Score using the disclosing two tone liquid by Curaprox
次要结局
- Satisfaction and Ease of Usage of the Dental Monitoring Application/Kit(At the end of Visit 2 (between Day 28 and 35))
