NCT06830161

Brief Summary

This study investigates a novel approach for detecting gingival inflammation using thermal imaging and artificial intelligence (AI). Thermal imaging is a technique that utilizes heat to generate detailed images, while AI assists in analyzing these images to identify patterns. Unlike traditional methods that require direct contact or visual examination, this approach is non-invasive, eliminating the need for physical interaction with the gingiva or reliance on subjective assessments. A key aspect of this study is its focus on individuals with mouth breathing, a condition that complicates gingival health monitoring. By utilizing thermal imaging, the study successfully detected and classified gingival inflammation levels (healthy, mild, moderate, or severe) based on heat distribution patterns. Additionally, specific temperature thresholds were established to differentiate between healthy and inflamed gingival tissues in this patient group, representing a novel contribution to the field. The developed AI system demonstrated high accuracy in identifying inflammation. This technology has the potential to facilitate earlier detection of gingival disease, even before clinical symptoms become evident. Furthermore, it offers a fast, painless, and reliable method for monitoring gingival health over time, enhancing accessibility and improving patient experience in dental care. These findings suggest that the integration of thermal imaging and AI could significantly improve the diagnosis and management of gingival diseases. Future research could further refine this technology by expanding the sample size and optimizing analytical models to enhance accuracy and widespread applicability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

February 5, 2025

Last Update Submit

February 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Classification Performance of AI Model in Detecting Gingival Inflammation from Thermal Imaging Data

    The performance of the AI model in detecting gingival inflammation is assessed using classification metrics derived from thermal imaging data. The model's effectiveness is evaluated based on overall accuracy, precision, sensitivity (recall), specificity, and F1-score. The classification process is performed using the XGBoost algorithm, with a 5-fold cross-validation approach to ensure reliability. The final accuracy and performance metrics are calculated as the mean and standard deviation of cross-validation results.

    6 months

Study Arms (1)

Inflammation 0, Inflammation 1, Inflammation 2, Inflammation 3

Normal Gingiva Mild Inflammation Moderate Inflammation Severe Inflammation

Diagnostic Test: Gingival Thermal Images

Interventions

The degree of inflammation was evaluated using the Gingival Index

Inflammation 0, Inflammation 1, Inflammation 2, Inflammation 3

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participants were selected from individuals presenting to the Department of Periodontology, Faculty of Dentistry, Gazi University who suffers from mouth breathing.

You may qualify if:

  • Having at least 20 teeth
  • Being between 18 and 25 years old and systemically healthy.
  • No periodontal treatment within the last 6 months.

You may not qualify if:

  • Presence of any acute infection
  • Use of systemic antibiotics or anti-inflammatory drugs within the past three months
  • History of systemic diseases
  • Pregnancy and/or lactation
  • Xerostomia or drug-induced gingival inflammation
  • Current or former smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Dentistry Department of Periodontology

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Zeynep Turgut Çankaya

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gazi University

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 17, 2025

Study Start

July 30, 2024

Primary Completion

January 1, 2025

Study Completion

January 2, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
always

Locations