Clinical trial NCT05809570: Periodontal Disease Prediction System
Official title: Periodontal Disease Prediction System and a Patient-Specific Gingival Recession Simulator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: gingival recession
Oral hygiene motivation
Computer-aided design
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Abant Izzet Baysal University
name: Istanbul Technical University
name: The Scientific and Technological Research Council of Turkey
First posted: 2023-04-12
Enrollment: 1057
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of sites Clinical Attachment Loss≥5 mm
timeFrame: Baseline
Secondary outcomes:
measure: Presence of diabetes
timeFrame: Baseline
measure: Smoking status
timeFrame: Baseline
measure: Patient cooperation and awareness
timeFrame: Baseline
measure: History of dental treatment
timeFrame: Baseline
measure: Tooth brushing Habits
timeFrame: Baseline
measure: Interproximal cleaning
timeFrame: Baseline
measure: Alveolar bone loss/age
timeFrame: Baseline
measure: Number of sites Probing Pocket Depth ≥5 mm
timeFrame: Baseline
measure: Number of sites Bleeding on Probing (%)
timeFrame: Baseline
measure: Tooth mobility
timeFrame: Baseline
measure: Gingival phenotype
timeFrame: Baseline
measure: Presence of furcation involvement
timeFrame: Baseline
measure: Vertical alveolar bone loss
timeFrame: Baseline
measure: Presence of endodontic tooth problem
timeFrame: Baseline
measure: Number of tooth loss
timeFrame: Baseline
measure: Traumatic occlusion
timeFrame: Baseline
measure: Restorations including gingival margin
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Şadiye Günpınar, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References: