Skip to main content
OpenTrials
Completed

NCT Number: NCT05809570

Periodontal Disease Prediction System

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clinical examination

Diagnostic Test

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.

Primary outcomes

  1. Number of sites Clinical Attachment Loss≥5 mm

    Time frame: Baseline

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

Secondary outcomes

  1. Presence of diabetes

    Time frame: Baseline

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

  2. Smoking status

    Time frame: Baseline

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

  3. Patient cooperation and awareness

    Time frame: Baseline

    Categorized as: None, some, high

  4. History of dental treatment

    Time frame: Baseline

    Categorized as: None, treated in the last 1 year

  5. Tooth brushing Habits

    Time frame: Baseline

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

  6. Interproximal cleaning

    Time frame: Baseline

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

  7. Alveolar bone loss/age

    Time frame: Baseline

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

  8. Number of sites Probing Pocket Depth ≥5 mm

    Time frame: Baseline

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

  9. Number of sites Bleeding on Probing (%)

    Time frame: Baseline

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

  10. Tooth mobility

    Time frame: Baseline

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

  11. Gingival phenotype

    Time frame: Baseline

    Categorized as: Thin/thick

  12. Presence of furcation involvement

    Time frame: Baseline

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

  13. Vertical alveolar bone loss

    Time frame: Baseline

    Categorized as: Presence/absence

  14. Presence of endodontic tooth problem

    Time frame: Baseline

    Categorized as: Presence/absence

  15. Number of tooth loss

    Time frame: Baseline

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

  16. Traumatic occlusion

    Time frame: Baseline

    Categorized as: Presence/absence

  17. Restorations including gingival margin

    Time frame: Baseline

    Categorized as: Presence/absence

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

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

Registry information

Official study title

Periodontal Disease Prediction System and a Patient-Specific Gingival Recession Simulator

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2023
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.