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Periodontal DiseasesNCT05068778

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

An observational study of Periodontal Diseases, run by McGuire Institute at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An Artificial Intelligence platform to develop an app which improves compliance in periodontal treatments Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Periodontal Diseases
What is being tested?
Artificial Intelligence Application
How many people
50 participants
Where
2 sitesUnited States
Study dates
10 Sep 2021to 1 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.
  • -
  • -

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Perio Health Professionals

    Houston, Texas, 77063-7229

  • Metro West Orthodontics & Periodontics

    La Vista, Nebraska, 68128

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
Artificial Intelligence Application
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial Intelligence ApplicationBehavioural

    AI application through smart phone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify the input variables the AI utilizes to arrive at CS assignment and message selection for subject interaction via DDH app

    Digital hygiene app will provide messages to subjects via their smartphone regarding their their lst maintenance appointment and throughout the study.

    Measured: through study completion, approximately 7 months

Secondary outcomes (6)

  1. Compliance Score Accuracy

    the increase the compliance score ant 3 and 6 months after subject begins use of the AI app

    Measured: 6 months

  2. change in recession

    number of subjects with a lesser degree of recession from baseline to end of study due to increased subject compliance

    Measured: 6 months

  3. change in probing depth

    number of subjects with a lesser probing depth from baseline to end of study due to increased subject compliance

    Measured: 6 months

  4. change in clinical attachment level

    number of subjects with improved clinical attachment level due to increased subject compliance

    Measured: 6 months

  5. change in gingival inflammation

    number of subjects with a reduction in gingival inflammation due to increased subject compliance

    Measured: 6 months

  6. decrease mobility

    number of subjects showing a decreased degree of tooth mobility due to increased subject compliance

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2021
  2. Study start10 Sep 2021
  3. Primary completion30 Jan 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068778
Sponsor's protocol ID
Asua 001-2020
Status last verified
May 2022
First submitted
27 Aug 2021
Last updated
26 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shapiro SC. Encyclopedia of Artificial Intelligence. New York: Wiley; 1992.

  • Park WJ, Park JB. History and application of artificial neural networks in dentistry. Eur J Dent. 2018 Oct-Dec;12(4):594-601. doi: 10.4103/ejd.ejd_325_18.

    PubMed 30369809

  • Jackson P. Introduction to Expert Systems. London: Addison Wesley; 1986

  • Khanna S. Artificial intelligence: contemporary applications and future compass. Int Dent J. 2010 Aug;60(4):269-72.

    PubMed 20949757

  • Xie X, Wang L, Wang A. Artificial neural network modeling for deciding if extractions are necessary prior to orthodontic treatment. Angle Orthod. 2010 Mar;80(2):262-6. doi: 10.2319/111608-588.1.

    PubMed 19905850

  • Kim EY, Lim KO, Rhee HS. Predictive modeling of dental pain using neural network. Stud Health Technol Inform. 2009;146:745-6.

    PubMed 19592958

  • Reddy MS, Shetty SR, Shetty RM, Vannala V, Sk S. Future of periodontics lies in artificial intelligence: Myth or reality? J Investig Clin Dent. 2019 Nov;10(4):e12423. doi: 10.1111/jicd.12423. Epub 2019 May 23. No abstract available.

    PubMed 31120578

  • Wilson TG Jr, Glover ME, Malik AK, Schoen JA, Dorsett D. Tooth loss in maintenance patients in a private periodontal practice. J Periodontol. 1987 Apr;58(4):231-5. doi: 10.1902/jop.1987.58.4.231.

    PubMed 3295181

  • Miyamoto T, Kumagai T, Jones JA, Van Dyke TE, Nunn ME. Compliance as a prognostic indicator: retrospective study of 505 patients treated and maintained for 15 years. J Periodontol. 2006 Feb;77(2):223-32. doi: 10.1902/jop.2006.040349.

    PubMed 16460248

  • McGuire MK, Nunn ME. Prognosis versus actual outcome. III. The effectiveness of clinical parameters in accurately predicting tooth survival. J Periodontol. 1996 Jul;67(7):666-74. doi: 10.1902/jop.1996.67.7.666.

    PubMed 8832477

  • Needleman I, Nibali L, Di Iorio A. Professional mechanical plaque removal for prevention of periodontal diseases in adults--systematic review update. J Clin Periodontol. 2015 Apr;42 Suppl 16:S12-35. doi: 10.1111/jcpe.12341.

    PubMed 25495962

  • Tonetti MS, Eickholz P, Loos BG, Papapanou P, van der Velden U, Armitage G, Bouchard P, Deinzer R, Dietrich T, Hughes F, Kocher T, Lang NP, Lopez R, Needleman I, Newton T, Nibali L, Pretzl B, Ramseier C, Sanz-Sanchez I, Schlagenhauf U, Suvan JE. Principles in prevention of periodontal diseases: Consensus report of group 1 of the 11th European Workshop on Periodontology on effective prevention of periodontal and peri-implant diseases. J Clin Periodontol. 2015 Apr;42 Suppl 16:S5-11. doi: 10.1111/jcpe.12368.

    PubMed 25639948

  • Asimakopoulou K, Nolan M, McCarthy C, Newton JT. The effect of risk communication on periodontal treatment outcomes: A randomized controlled trial. J Periodontol. 2019 Sep;90(9):948-956. doi: 10.1002/JPER.18-0385. Epub 2019 Apr 17.

    PubMed 30997690

  • Amerio E, Mainas G, Petrova D, Giner Tarrida L, Nart J, Monje A. Compliance with supportive periodontal/peri-implant therapy: A systematic review. J Clin Periodontol. 2020 Jan;47(1):81-100. doi: 10.1111/jcpe.13204. Epub 2019 Nov 13.

    PubMed 31562778

  • Asimakopoulou K, Newton JT, Daly B, Kutzer Y, Ide M. The effects of providing periodontal disease risk information on psychological outcomes - a randomized controlled trial. J Clin Periodontol. 2015 Apr;42(4):350-5. doi: 10.1111/jcpe.12377. Epub 2015 Mar 24.

    PubMed 25682859

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases, run by McGuire Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05068778, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.

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