Periodontal Diseases
Conditions
Brief summary
An Artificial Intelligence platform to develop an app which improves compliance in periodontal treatments
Detailed description
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.
Interventions
BEHAVIORALArtificial Intelligence Application
AI application through smart phone
Sponsors
Asua, Inc
McGuire Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To identify the input variables the AI utilizes to arrive at CS assignment and message selection for subject interaction via DDH app | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in recession | 6 months | number of subjects with a lesser degree of recession from baseline to end of study due to increased subject compliance |
| change in probing depth | 6 months | number of subjects with a lesser probing depth from baseline to end of study due to increased subject compliance |
| change in clinical attachment level | 6 months | number of subjects with improved clinical attachment level due to increased subject compliance |
| change in gingival inflammation | 6 months | number of subjects with a reduction in gingival inflammation due to increased subject compliance |
| decrease mobility | 6 months | number of subjects showing a decreased degree of tooth mobility due to increased subject compliance |
| Compliance Score Accuracy | 6 months | the increase the compliance score ant 3 and 6 months after subject begins use of the AI app |
Other
| Measure | Time frame | Description |
|---|---|---|
| AI generated surveys | 6 months | survey to determine subjects progress, risk disease, oral hygiene needs, coping and goal setting abilities, and compliance |
| Hygienist In office subject survey | 6 months | to measure subjects hygiene and other life events (e.g. work stress) |
| Subject demographics | 6 months | determination of demographics on subjects with periodontal disease |
| PRO | 6 months | PRO for subject experience using the AI app system |
Countries
United States
Outcome results
None listed