Periodontal Disease Prediction System

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT05809570
Collaborator
Abant Izzet Baysal University (Other), Istanbul Technical University (Other), The Scientific and Technological Research Council of Turkey (Other)
1,057
1
24
44.1

Study Details

Study Description

Brief Summary

The purpose of this study was to develop a periodontal disease prediction software and a patient-based gingival recession simulator for clinical practice aiming at improving oral hygiene motivation of patients with periodontal problems.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Clinical examination

Detailed Description

Periodontal Disease Prediction (PDP) software has three components: a) Data Loading Window (DLW) b) Three-Dimensional Mouth Model (3DM) and c) Periodontal Attachment Loss Indicator (PLI). Demographic and clinical examinations of 1057 volunteers were recorded to DLW. An unsupervised machine learning K means clustering analysis was used to categorize the data obtained from the study population and identified the periodontal risk groups. An intraoral scanner was utilized to capture direct optical intraoral data of a patient and transferred to the 3DM. The intraoral model went under two algorithm steps for obtaining a recessed model. First, gingival curves separating gingiva and tooth were extracted using a Dijkstra's algorithm. Limit curves determining boundaries of recessed regions in the intraoral model were then obtained using gingival curves. The gingival recession was then mimicked by losing gingiva and disappearing tooth roots at proper locations in the intraoral model and Additionally, the final four different 3 dimensional recessed model (maxilla, mandibula, anterior teeth and posterior teeth) belonging to the same patient were scored based on the similarity to the real gingival recession by 25 periodontology specialist via online survey.

Study Design

Study Type:
Observational
Actual Enrollment :
1057 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Periodontal Disease Prediction System and a Patient-Specific Gingival Recession Simulator
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Periodontal examination

Cross- sectional clinical periodontal examinations and measurements were performed using a Williams periodontal probe

Diagnostic Test: Clinical examination
A total of 1057 individuals who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology and agreed to participate in the study were clinically and radiologically examined. An intraoral scanner was utilized to capture direct optical intraoral data of a patient.

Outcome Measures

Primary Outcome Measures

  1. Number of sites Clinical Attachment Loss≥5 mm [Baseline]

    Categorized as: None, <4, 4-8, >8

Secondary Outcome Measures

  1. Presence of diabetes [Baseline]

    Categorized as: Absence, diabetes with HbA1c<7, diabetes with HbA1c≥7

  2. Smoking status [Baseline]

    Categorized as: None, < 10 per day, ≥10 per day

  3. Patient cooperation and awareness [Baseline]

    Categorized as: None, some, high

  4. History of dental treatment [Baseline]

    Categorized as: None, treated in the last 1 year

  5. Tooth brushing Habits [Baseline]

    Categorized as: None/ 1 time in day/ ≥2 times in day

  6. Interproximal cleaning [Baseline]

    Categorized as: None/ 1 time in day/ ≥2 times in day

  7. Alveolar bone loss/age [Baseline]

    Categorized as: None/ <0.25 /0.25-1/ >1

  8. Number of sites Probing Pocket Depth ≥5 mm [Baseline]

    Categorized as: None/ <4 / 4-8/ >8

  9. Number of sites Bleeding on Probing (%) [Baseline]

    Categorized as: <10%/ 10-25%/ >25%

  10. Tooth mobility [Baseline]

    Categorized as: None/ Miller I/ Miller II/ Miller III

  11. Gingival phenotype [Baseline]

    Categorized as: Thin/thick

  12. Presence of furcation involvement [Baseline]

    Categorized as: None/ horizontal involvement/ vertical involvement/ combined

  13. Vertical alveolar bone loss [Baseline]

    Categorized as: Presence/absence

  14. Presence of endodontic tooth problem [Baseline]

    Categorized as: Presence/absence

  15. Number of tooth loss [Baseline]

    Categorized as: None/ <4/ 4-8/ >8

  16. Traumatic occlusion [Baseline]

    Categorized as: Presence/absence

  17. Restorations including gingival margin [Baseline]

    Categorized as: Presence/absence

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age greater than 18 years,

  • Periodontal status ranging from no clinical periodontal disease (<10% with bleeding on probing) to periodontitis (stage I to IV)

  • Patients having at least one teeth in each quadrant were included.

Exclusion Criteria:
  • Patients undergoing orthodontic treatment and using anti-inflammatory drugs were excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem Vakif University Istanbul Turkey

Sponsors and Collaborators

  • Bezmialem Vakif University
  • Abant Izzet Baysal University
  • Istanbul Technical University
  • The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Şadiye Günpınar, Assoc. Prof, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Şadiye GÜNPINAR, Principal Investigator, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT05809570
Other Study ID Numbers:
  • 119S025
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Şadiye GÜNPINAR, Principal Investigator, Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2023