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Development of an AI App to Improve Compliance in Periodontal Maintenance Patients

2022年5月25日 更新者:McGuire Institute

Development of an Artificial Intelligence Platform / Digital Dental Hygienist to Improve Compliance in Periodontal Maintenance Patients

An Artificial Intelligence platform to develop an app which improves compliance in periodontal treatments

研究概览

地位

主动,不招人

条件

详细说明

To develop the accuracy of an AI-determined decision-making process for compliance score (CS) assignment, to assess clinical efficacy, and develop patient reported outcomes of AI-facilitated communication / education on a subject's oral health behaviors over successive maintenance visits.

研究类型

观察性的

注册 (实际的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Nebraska
      • La Vista、Nebraska、美国、68128
        • Metro West Orthodontics & Periodontics
    • Texas
      • Houston、Texas、美国、77063-7229
        • Perio Health Professionals

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

50 subjects minimum, 18-75 years of age, treated for periodontitis in a private practice who are currently following a periodontal maintenance regimen.

描述

Inclusion Criteria:

  1. Subjects 18 to 75-yrs of age
  2. Subjects with diagnosis and treatment of Generalized and/or Localized Periodontitis Stages I, II, or III; grades A-C and or Peri-implantitis (Generalized Mild, Moderate, or Advanced Chronic Periodontitis) who are following a periodontal maintenance interval of every three months.
  3. Subjects are able to provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
  4. Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
  5. Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

  1. Subjects who do not own or are incapable of interacting with a smart phone or device
  2. Subjects who are incapable of operating an application on a smart phone or device
  3. Subjects who are not compliant with periodontal maintenance / recall intervals (Based on Wilson's classification as any lack of compliance with their recommended maintenance interval- therefore exclude subjects who demonstrate erratic compliance or noncompliance)18
  4. Subjects who require active periodontal therapy during the study
  5. Subjects who are on immunosuppressive medications, chemotherapy, or radiation therapy which would adversely affect their periodontal stability.
  6. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
  7. Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

    -

    Exclusion Criteria:

    -

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To identify the input variables the AI utilizes to arrive at CS assignment and message selection for subject interaction via DDH app
大体时间:through study completion, approximately 7 months
Digital hygiene app will provide messages to subjects via their smartphone regarding their their lst maintenance appointment and throughout the study.
through study completion, approximately 7 months

次要结果测量

结果测量
措施说明
大体时间
Compliance Score Accuracy
大体时间:6 months
the increase the compliance score ant 3 and 6 months after subject begins use of the AI app
6 months
change in recession
大体时间:6 months
number of subjects with a lesser degree of recession from baseline to end of study due to increased subject compliance
6 months
change in probing depth
大体时间:6 months
number of subjects with a lesser probing depth from baseline to end of study due to increased subject compliance
6 months
change in clinical attachment level
大体时间:6 months
number of subjects with improved clinical attachment level due to increased subject compliance
6 months
change in gingival inflammation
大体时间:6 months
number of subjects with a reduction in gingival inflammation due to increased subject compliance
6 months
decrease mobility
大体时间:6 months
number of subjects showing a decreased degree of tooth mobility due to increased subject compliance
6 months

其他结果措施

结果测量
措施说明
大体时间
PRO
大体时间:6 months
PRO for subject experience using the AI app system
6 months
Subject demographics
大体时间:6 months
determination of demographics on subjects with periodontal disease
6 months
AI generated surveys
大体时间:6 months
survey to determine subjects progress, risk disease, oral hygiene needs, coping and goal setting abilities, and compliance
6 months
Hygienist In office subject survey
大体时间:6 months
to measure subjects hygiene and other life events (e.g. work stress)
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 研究主任:Rick Heard, DDS、The McGuire Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月10日

初级完成 (预期的)

2023年1月30日

研究完成 (预期的)

2023年6月1日

研究注册日期

首次提交

2021年8月27日

首先提交符合 QC 标准的

2021年9月24日

首次发布 (实际的)

2021年10月6日

研究记录更新

最后更新发布 (实际的)

2022年5月26日

上次提交的符合 QC 标准的更新

2022年5月25日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Asua 001-2020

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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