Clinical trial NCT05068778: Development of an AI App to Improve Compliance in Periodontal Maintenance Patients
Official title: Development of an Artificial Intelligence Platform / Digital Dental Hygienist to Improve Compliance in Periodontal Maintenance Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Diseases
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
Collaborators: name: Asua, Inc
First posted: 2021-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 subjects minimum, 18-75 years of age, treated for periodontitis in a private practice who are currently following a periodontal maintenance regimen.

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.

Eligibility criteria: 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.

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   Exclusion Criteria:

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Primary outcomes:
measure: To identify the input variables the AI utilizes to arrive at CS assignment and message selection for subject interaction via DDH app
timeFrame: through study completion, approximately 7 months
Secondary outcomes:
measure: Compliance Score Accuracy
timeFrame: 6 months
measure: change in recession
timeFrame: 6 months
measure: change in probing depth
timeFrame: 6 months
measure: change in clinical attachment level
timeFrame: 6 months
measure: change in gingival inflammation
timeFrame: 6 months
measure: decrease mobility
timeFrame: 6 months
Other outcomes:
measure: PRO
timeFrame: 6 months
measure: Subject demographics
timeFrame: 6 months
measure: AI generated surveys
timeFrame: 6 months
measure: Hygienist In office subject survey
timeFrame: 6 months
Locations:
city: La Vista
country: United States
facility: Metro West Orthodontics & Periodontics
state: Nebraska
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
Study officials:
affiliation: The McGuire Institute
name: Rick Heard, DDS
role: STUDY_DIRECTOR
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