NCT05068778Unknown不适用
Development of an Artificial Intelligence Platform / Digital Dental Hygienist to Improve Compliance in Periodontal Maintenance Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To identify the input variables the AI utilizes to arrive at CS assignment and message selection for subject interaction via DDH app
研究概览
简要总结
An Artificial Intelligence platform to develop an app which improves compliance in periodontal treatments
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 75-yrs of age
- •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.
- •Subjects are able to provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
- •Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- •Subjects must be able and willing to follow study procedures and instructions.
排除标准
- •Subjects who do not own or are incapable of interacting with a smart phone or device
- •Subjects who are incapable of operating an application on a smart phone or device
- •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
- •Subjects who require active periodontal therapy during the study
- •Subjects who are on immunosuppressive medications, chemotherapy, or radiation therapy which would adversely affect their periodontal stability.
- •Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
- •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:
结局指标
主要结局
To identify the input variables the AI utilizes to arrive at CS assignment and message selection for subject interaction via DDH app
时间窗: 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.
次要结局
- Compliance Score Accuracy(6 months)
- change in recession(6 months)
- change in clinical attachment level(6 months)
- change in probing depth(6 months)
- change in gingival inflammation(6 months)
- decrease mobility(6 months)
研究者
研究点 (2)
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