NCT05068778

Brief Summary

An Artificial Intelligence platform to develop an app which improves compliance in periodontal treatments

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

August 27, 2021

Last Update Submit

May 25, 2022

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (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.

    through study completion, approximately 7 months

Secondary Outcomes (6)

  • Compliance Score Accuracy

    6 months

  • change in recession

    6 months

  • change in probing depth

    6 months

  • change in clinical attachment level

    6 months

  • change in gingival inflammation

    6 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • PRO

    6 months

  • Subject demographics

    6 months

  • AI generated surveys

    6 months

  • +1 more other outcomes

Interventions

Artificial Intelligence ApplicationBEHAVIORAL

AI application through smart phone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Metro West Orthodontics & Periodontics

La Vista, Nebraska, 68128, United States

Location

Perio Health Professionals

Houston, Texas, 77063-7229, United States

Location

Related Publications (21)

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

    BACKGROUND

  • 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.

    PMID: 30369809BACKGROUND

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

    BACKGROUND

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

    PMID: 20949757BACKGROUND

  • 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.

    PMID: 19905850BACKGROUND

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

    PMID: 19592958BACKGROUND

  • 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.

    PMID: 31120578BACKGROUND

  • 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.

    PMID: 3295181BACKGROUND

  • 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.

    PMID: 16460248BACKGROUND

  • 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.

    PMID: 8832477BACKGROUND

  • 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.

    PMID: 25495962BACKGROUND

  • 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.

    PMID: 25639948BACKGROUND

  • 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.

    PMID: 30997690BACKGROUND

  • 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.

    PMID: 31562778BACKGROUND

  • 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.

    PMID: 25682859BACKGROUND

  • Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015 Apr;42 Suppl 16:S36-46. doi: 10.1111/jcpe.12356.

    PMID: 25639708BACKGROUND

  • Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, Rodgers A, Cairns J, Kenward MG, Roberts I. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011 Jul 2;378(9785):49-55. doi: 10.1016/S0140-6736(11)60701-0.

    PMID: 21722952BACKGROUND

  • Wilson TG Jr, Glover ME, Schoen J, Baus C, Jacobs T. Compliance with maintenance therapy in a private periodontal practice. J Periodontol. 1984 Aug;55(8):468-73. doi: 10.1902/jop.1984.55.8.468.

    PMID: 6384465BACKGROUND

  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

    PMID: 29926952BACKGROUND

  • Miller SC. Textbook of Periodontia: Philadelphia, Blakiston; 1938

    BACKGROUND

  • O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

    PMID: 4500182BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Rick Heard, DDS

    The McGuire Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

October 6, 2021

Study Start

September 10, 2021

Primary Completion

January 30, 2023

Study Completion

June 1, 2023

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)