Periodontal Disease Prediction System

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809570
• Other study ID #: 119S025
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1057
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Periodontal Diseases

Intervention

Diagnostic Test:
• Clinical examination
A total of 1057 individuals who applied to Bolu Abant Izzet 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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (4)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Abant Izzet Baysal University, Istanbul Technical University, The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

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