Periodontal Disease Prediction System

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1057

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients who applied to Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology for their rutin periodontal controls or complains about gingival problems were included in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sites Clinical Attachment Loss≥5 mm	Categorized as: None, <4, 4-8, >8	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of diabetes	Categorized as: Absence, diabetes with HbA1c<7, diabetes with HbA1c≥7	Baseline
Smoking status	Categorized as: None, < 10 per day, ≥10 per day	Baseline
Patient cooperation and awareness	Categorized as: None, some, high	Baseline
History of dental treatment	Categorized as: None, treated in the last 1 year	Baseline
Tooth brushing Habits	Categorized as: None/ 1 time in day/ ≥2 times in day	Baseline
Interproximal cleaning	Categorized as: None/ 1 time in day/ ≥2 times in day	Baseline
Alveolar bone loss/age	Categorized as: None/ <0.25 /0.25-1/ >1	Baseline
Number of sites Probing Pocket Depth ≥5 mm	Categorized as: None/ <4 / 4-8/ >8	Baseline
Number of sites Bleeding on Probing (%)	Categorized as: <10%/ 10-25%/ >25%	Baseline
Tooth mobility	Categorized as: None/ Miller I/ Miller II/ Miller III	Baseline
Gingival phenotype	Categorized as: Thin/thick	Baseline
Presence of furcation involvement	Categorized as: None/ horizontal involvement/ vertical involvement/ combined	Baseline
Vertical alveolar bone loss	Categorized as: Presence/absence	Baseline
Presence of endodontic tooth problem	Categorized as: Presence/absence	Baseline
Number of tooth loss	Categorized as: None/ <4/ 4-8/ >8	Baseline
Traumatic occlusion	Categorized as: Presence/absence	Baseline
Restorations including gingival margin	Categorized as: Presence/absence	Baseline

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: The Scientific and Technological Research Council of Turkey; Abant Izzet Baysal University; Istanbul Technical University
• Investigators: Principal Investigator: Şadiye Günpınar, Assoc. Prof, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: gingival recession; Oral hygiene motivation; Computer-aided design
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession; Periodontal Diseases
• Other Study ID Numbers: 119S025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared if the researchers contact to the principal investigator after 6 months following the publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No