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

• Conditions: Periodontal Diseases

• Registration Number: NCT05068778
• Lead Sponsor: McGuire Institute

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.

Study Timeline

• Study First Submitted: 2021-08-27
• Study Start: 2021-09-10
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26
• Primary Completion: 2023-01-30
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Compliance Score Accuracy	6 months	the increase the compliance score ant 3 and 6 months after subject begins use of the AI app
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 clinical attachment level	6 months	number of subjects with improved clinical attachment level 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 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

Trial Locations

Locations (2)

Metro West Orthodontics & Periodontics; 🇺🇸 La Vista, Nebraska, United States

Perio Health Professionals; 🇺🇸 Houston, Texas, United States