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

6 de maio de 2026 atualizado por: Sude Yildirim, Ondokuz Mayıs University

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

The study population will consist of systemically and periodontally healthy adults attending the Department of Periodontology at Ondokuz Mayıs University, Faculty of Dentistry, for routine dental care or check-up. Eligible participants will have natural maxillary anterior incisors and meet all inclusion criteria.

Additionally, the examiner population will include:

Periodontology research assistants currently working in the department.

Fourth- and fifth-year dental intern students who have completed the periodontology clinical rotation.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Dental Students
Fourth- and fifth-year dental intern students will assess standardized intraoral photographs using both the periodontal probe transparency method and visual assessment to classify gingival phenotype.
Standardized intraoral photography of the maxillary anterior teeth with a periodontal probe placed according to the transparency method protocol to determine probe visibility status.
Standardized intraoral photography of the maxillary anterior teeth without a periodontal probe, evaluated for gingival phenotype classification based on morphological features.
Artificial Intelligence Model
A deep learning-based image classification model will analyze standardized intraoral photographs, detecting probe visibility and classifying gingival phenotype according to the periodontal probe transparency method and visual assessment criteria.
Standardized intraoral photography of the maxillary anterior teeth with a periodontal probe placed according to the transparency method protocol to determine probe visibility status.
Standardized intraoral photography of the maxillary anterior teeth without a periodontal probe, evaluated for gingival phenotype classification based on morphological features.
A deep learning image classification algorithm trained to assess probe visibility and gingival phenotype from standardized intraoral photographs.
Periodontology Research Assistants
Research assistants in periodontology will assess standardized intraoral photographs using both the periodontal probe transparency method and visual assessment to classify gingival phenotype.
Standardized intraoral photography of the maxillary anterior teeth with a periodontal probe placed according to the transparency method protocol to determine probe visibility status.
Standardized intraoral photography of the maxillary anterior teeth without a periodontal probe, evaluated for gingival phenotype classification based on morphological features.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Diagnostic Accuracy of Each Examiner Group and AI Model in the Periodontal Probe Transparency Method
Prazo: 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.

At the time of image evaluation (single session).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Diagnostic Accuracy of Each Examiner Group and AI Model in Visual Assessment Method
Prazo: 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 (%).

At the time of image evaluation (single session).
Agreement Between Examiner Groups and AI Model
Prazo: 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).
At the time of image evaluation and at 2-week retest (for a random subset of evaluators).
Effect of Examiner Experience Level on Diagnostic Performance
Prazo: 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.

At the time of image evaluation (single session).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de maio de 2026

Conclusão Primária (Estimado)

15 de agosto de 2026

Conclusão do estudo (Estimado)

15 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

29 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de abril de 2026

Primeira postagem (Real)

6 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • OMUKAEK NO:225/335

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified individual participant data (IPD), including demographic characteristics, periodontal measurements, and standardized intraoral photographs, may be shared upon reasonable request for academic purposes. Access will require a data use agreement and approval by the principal investigator.

Prazo de Compartilhamento de IPD

De-identified IPD and supporting documents will be available within 12 months after publication of the main results and will remain available for at least 5 years.

Critérios de acesso de compartilhamento IPD

https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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