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

May 25, 2022 updated by: 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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • La Vista, Nebraska, United States, 68128
        • Metro West Orthodontics & Periodontics
    • Texas
      • Houston, Texas, United States, 77063-7229
        • Perio Health Professionals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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:

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify the input variables the AI utilizes to arrive at CS assignment and message selection for subject interaction via DDH app
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance Score Accuracy
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
number of subjects with improved clinical attachment level due to increased subject compliance
6 months
change in gingival inflammation
Time Frame: 6 months
number of subjects with a reduction in gingival inflammation due to increased subject compliance
6 months
decrease mobility
Time Frame: 6 months
number of subjects showing a decreased degree of tooth mobility due to increased subject compliance
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRO
Time Frame: 6 months
PRO for subject experience using the AI app system
6 months
Subject demographics
Time Frame: 6 months
determination of demographics on subjects with periodontal disease
6 months
AI generated surveys
Time Frame: 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
Time Frame: 6 months
to measure subjects hygiene and other life events (e.g. work stress)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGuire Institute

Collaborators

Asua, Inc

Investigators

  • Study Director: Rick Heard, DDS, The McGuire Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Anticipated)

January 30, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asua 001-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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