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NCT Number: NCT07570290

Comparison of Artificial Intelligence and Clinicians With Different Experience Levels in Assessing Gingival Phenotype

The goal of this observational study is to compare the performance of clinicians with different experience levels and a deep learning-based artificial intelligence (AI) model in assessing gingival phenotype using two diagnostic methods: the periodontal probe transparency method and visual assessment from standardized clinical photographs. The main questions the study aims to answer are:

Can AI achieve comparable accuracy to human examiners in both probe transparency and visual assessment methods?

Does examiner experience level influence diagnostic performance and agreement with the reference standard in these methods?

Researchers will compare AI, dental students, and periodontology research assistants to determine accuracy, sensitivity, specificity, and agreement with the gold standard for each method.

Participants will:

Undergo standardized intraoral photography of maxillary anterior teeth, with and without a periodontal probe in place, following a validated protocol.

Have gingival phenotype determined by a reference periodontologist using the probe transparency method as the gold standard.

Have their photographs evaluated by AI, dental students, and research assistants for phenotype classification using both methods.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Gingival phenotype, representing the thickness and morphological characteristics of the gingival soft tissues, plays a critical role in periodontal health, treatment planning, and the long-term stability of clinical outcomes. A thin phenotype is associated with increased risk of gingival recession, papilla loss, and inflammatory complications, while a thick phenotype offers better soft tissue stability but may mask inflammation. Accurate and reproducible assessment of gingival phenotype is therefore essential in clinical dentistry.

The periodontal probe transparency method is considered the gold standard for phenotype assessment due to its simplicity and non-invasiveness. In this method, a periodontal probe is inserted into the sulcus from the buccal aspect, and if the probe is visible through the gingival tissue, the phenotype is classified as thin; if not visible, it is classified as thick. However, the method is susceptible to variability depending on examiner experience, lighting conditions, and subjective interpretation.

Visual assessment, which relies solely on the inspection of gingival and tooth morphology in photographs without a probe, offers a non-contact alternative but is similarly subject to examiner-related variability. These limitations highlight the need for standardized and objective approaches to phenotype determination.

Artificial intelligence (AI), particularly deep learning-based image analysis, has shown promising results in dental diagnostics, enabling automated classification of clinical images with high accuracy and reproducibility. In periodontal research, AI has been applied for lesion detection and radiographic interpretation, but its application in gingival phenotype assessment-especially using the probe transparency method and visual assessment-remains unexplored.

This observational study aims to compare the diagnostic performance of a deep learning-based AI model with human examiners of different experience levels (periodontology residents vs. dental students) in assessing gingival phenotype from standardized intraoral photographs using both the periodontal probe transparency method and visual assessment. The reference standard will be the classification provided by an experienced periodontologist using the probe transparency method in a clinical setting.

The study will evaluate and compare accuracy, sensitivity, specificity, and inter-/intra-examiner agreement across examiner groups and the AI model. The findings are expected to provide insights into the potential of AI as a standardizing tool, reducing inter-examiner variability and supporting clinical decision-making, particularly for less experienced clinicians. Additionally, the study may inform the integration of AI-assisted diagnostic tools in dental education and practice, improving training efficiency and clinical outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Volunteer Participants Who Will Participate in Transparency and Visual Assessment:

  • Systemically and periodontally healthy individuals.
  • Presence of natural maxillary anterior incisors.

Exclusion criteria

  • Presence of fixed crowns or cervical restorations on the evaluated teeth.
  • Pregnant or breastfeeding women.
  • Signs of gingival inflammation or periodontal disease with attachment loss.
  • Presence of buccal gingival recession.
  • Use of medications known to cause gingival enlargement.
  • Presence of congenital anomalies or dental structural defects.

Inclusion criteria

for Clinicians:

  • Research assistants: Must be currently working in the Department of Periodontology.
  • Dental Intern Students: Fourth- or fifth-year students who have completed periodontology clinical rotation.

Exclusion criteria

for Clinicians:

  • Those who are confirmed to be color blind by the Ishihara test

Treatment and study plan

Periodontal Probe Transparency Method

Diagnostic Test

Standardized intraoral photography of the maxillary anterior teeth with a periodontal probe placed according to the transparency method protocol to determine probe visibility status.

Visual Assessment Method

Diagnostic Test

Standardized intraoral photography of the maxillary anterior teeth without a periodontal probe, evaluated for gingival phenotype classification based on morphological features.

Deep Learning-Based Artificial Intelligence Model

Other

A deep learning image classification algorithm trained to assess probe visibility and gingival phenotype from standardized intraoral photographs.

Primary outcomes

  1. Diagnostic Accuracy of Each Examiner Group and AI Model in the Periodontal Probe Transparency Method

    Time frame: At the time of image evaluation (single session).

    Accuracy in determining probe visibility (visible vs. not visible) compared to the gold standard classification by an experienced periodontologist.

    Measure Type: Proportion (%). Analysis: Accuracy, sensitivity, specificity, and Cohen's kappa coefficient will be calculated.

Secondary outcomes

  1. Diagnostic Accuracy of Each Examiner Group and AI Model in Visual Assessment Method

    Time frame: At the time of image evaluation (single session).

    Accuracy in classifying gingival phenotype (thin vs. thick) without probe, compared to the gold standard classification.

    Measure Type: Proportion (%).

  2. Agreement Between Examiner Groups and AI Model

    Time frame: At the time of image evaluation and at 2-week retest (for a random subset of evaluators).

    Inter-examiner and intra-examiner agreement for each method, evaluated using Cohen's kappa coefficient and intraclass correlation coefficient (ICC).

  3. Effect of Examiner Experience Level on Diagnostic Performance

    Time frame: At the time of image evaluation (single session).

    Comparison of accuracy and agreement between research assistants and dental intern students for each method.

    Proportion (%), agreement statistic.

Study contacts

Contact information is provided by the study sponsor or research team.

Sude Yıldırım Bolat, DDS

CONTACT

[email protected]

+905378947645

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 11, 2026

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.