Clinical Practice Guideline

Updated at 2024-03-01

Our Clinical Practice Guidelines are comprised of the following:

  1. Transparent Algorithmic Logic
  2. Reference to Clinical Guidelines
  3. Accessibility of Sources
  4. Independence in Professional Judgment
  5. Continuous Updates and Revisions
  6. Adherence to Life Cycle Requirements for Medical Device Software

1. Transparent Algorithmic Logic for Pathology Detection Models

This section details the methodology employed by the Software to analyse data inputs to produce Software output recommendations.

  1. Data Input and Preprocessing

    Dental images, such as X-rays or 3D scans, chosen by the health practitioner are loaded into the system. The Software preprocesses these input images to enhance quality and clarity, which might include steps like normalisation, contrast adjustment, and noise reduction to ensure that the input images are in a consistent and appropriate format for AI analysis.

  2. Feature Extraction

    The Software then identifies and extracts key features from the input images relevant for pathology detection. This involves identifying specific landmarks in the tooth anatomy, such as the enamel, dentin, pulp, and periodontal ligament, and analysing these features for signs of disease or abnormality. The Software uses image recognition algorithms to distinguish between different structures within the tooth and surrounding tissues.

  3. Anomaly Detection

    Based on the extracted features, the Software applies algorithmic analysis to detect anomalies that may indicate potential pathology. This process involves a comparison of the observed features against normative contrast patterns. The model has been trained on a dataset of dental images annotated with expert diagnoses, allowing it to learn the patterns and characteristics that typically indicate potential pathology.

  4. Recommendation Logic

    When the Software detects an anomaly, it references a database (sourced from peer reviewed published research of dental pathologies), and their characteristics to classify the anomaly and suggest potential diagnoses. For example, if the Software detects an irregularity in the enamel’s thickness, it might suggest enamel erosion or dental caries as potential issues, based on the patterns it has learned during training.

  5. Result Interpretation and Guidance

    The Software output to the health professional includes not only the potential diagnosis but also an explanation of the findings that led to this conclusion. This might include highlighting areas of concern on the dental image and providing a summary of the features that the Software identified as indicative of potential pathology. The Software output also references the clinical guidelines or best practices that inform its recommendations, ensuring that health professionals can understand the basis of any Software outputs.

  6. User Interface and Interaction

    Health professionals can use the Software interface to review outputs, examine any highlighted areas of concern, and read the Software’s interpretations and recommendations. Health professionals have the option to accept, reject, or modify the Software’s recommendations based on their own clinical judgment and additional information.

2. Clinical Guidelines referenced in the Pathology Detection Model

The Software’s logic is informed by specific clinical guidelines, procedural standards, and practices that are foundational to its recommendations. For instance, when the software calculates the acceptable range for dental measurements, it references the clinical guideline defining this range, thereby ensuring transparency and reliability.

Caries Detection

  • Occlusal and Proximal Caries

    The Software’s ability to identify occlusal and proximal caries is based on radiographic criteria outlined in the study published on NCBI, which provides a detailed description of radiographic diagnosis for these types of caries. The Software's logic for identifying these caries types incorporates the radiographic characteristics described under the heading “Radiographic diagnosis of caries lesions” in the article.

  • Root Caries

    For the detection of root caries, the Software’s logic is informed by the radiographic descriptions provided in the publication available on IJODontostomatology.

  • Recurrent Caries

    The Software implements guidelines from a study published on Tandfonline for detecting recurrent caries, especially focusing on radiographic descriptions of occlusal, proximal enamel, and dentinal caries.

    • Radiographic description of occlusal and proximal caries under the heading “Radiographic diagnosis of caries lesions” Reference
    • Radiographic description of root caries Reference
    • Radiographic description of occlusal, proximal enamel and dentinal, and recurrent caries Reference
    • Radiographic description of interproximal, occlusal, buccal and lingual, root surface, and recurrent caries Reference

Tooth Fracture

  • Vertical Root Fractures

    The detection of vertical root fractures is guided by radiographic characteristics detailed in the study from MDPI, which the Software uses to identify and differentiate these fractures in dental images.

  • Horizontal Root Fracture

    For horizontal root fractures, the Software logic for criteria informed by radiographic descriptions found in the case report on Cureus.

    • Detailed radiographic characteristics of vertical root fractures Reference
    • Radiographic description of horizontal root fracture Reference
    • A case study using 2D radiographs for the crown, crown-root, and root fractures Reference

Impacted Tooth

  • Impacted Mandibular Third Molars

    The Software's logic for identifying impacted mandibular third molars is informed by the detailed radiographic characteristics outlined in the publication on Hindawi.

    • Description of impacted teeth and type of pathological conditions associated with them Reference
    • Detailed radiographic characteristics of impacted mandibular third molars Reference
    • Radiographic descriptions of impacted maxillary canines Reference
    • Maxillary and Mandibular Third Molars Impaction with Associated Pathologies Reference
    • Impaction of Mandibular Second Premolar Reference

Retained Root, Root Resorption, and Other Conditions

  • Retained roots, root resorption, ectopic teeth, supernumerary teeth, and overhangs

    The Software’s logic is informed by respected studies and articles containing validated radiographic descriptions and clinical guidelines, such as those available on NCBI for retained roots and Nature for root resorption.

    Retained root

    • Description of the retained roots Root resorption Reference
    • Detailed guide for root resorptions. Radiographic appearance can be found in Table 1 Reference

    Ectopic tooth

    • Description and radiographic appearances of ectopic teeth Reference

    Supernumerary tooth

    • Radiographic description of supernumerary teeth under the heading “Developmental abnormalities > Number of Teeth Reference

    Overhang

    • Clinical and radiographic features of the approximal overhanging restorations Reference
    • Frequency and localization of the overhanging restorations by observing patients’ routinely taken panoramic radiographs Reference
    • Radiographic assessment of the quality of dental restorations and their relationship with periodontal radiographic changes Reference

    Defective margin

    • Detection of marginal defects of composite restorations with conventional and digital radiographs Reference
    • Radiographic assessment of the quality of dental restorations and their relationship with periodontal radiographic changes Reference

    Defective restoration

    • Radiographic assessment of the quality of dental restorations and their relationship with periodontal radiographic changes Reference

    Open contact

    • Description and appearance of open contacts Reference
    • A study confirming that open contacts increase the possibility of the spread of periodontal lesions Reference

    Pulp stone

    • Description of the pulp stones under the heading of “Acquired abnormalities” Reference
    • Radiographic appearance of the pulp stones Reference

    Obturation deficiency

    • Underfilled RCT Reference
    • Summary of evaluation criteria utilized for assessing the technical quality of root filling on the periapical radiographs > Unacceptable length Reference

    Obturation excess

    • Overfilled RCT Reference
    • Summary of evaluation criteria utilized for assessing the technical quality of root filling on the periapical radiographs > Unacceptable length Reference

    Obturation void

    • Under the “Root canal filling density” criteria Reference
    • Summary of evaluation criteria utilized for assessing the technical quality of root filling on the periapical radiographs > Unacceptable lateral adaptation Reference

    Furcation involvement

    • Radiographic appearance of Furcation involvement Reference
    • Detection of periodontal bone loss patterns and furcation defects from OPGs using AI. “For furcation defects” part under the “Ground truth” heading consists the detection logic of the furcation involvement Reference

    Intrabony defect

    • Detection of periodontal bone loss patterns from OPGs using AI. “For vertical bone losses” part under the “Ground truth” heading consists the detection logic of the vertical bone loss Reference
    • Radiographic morphology of intrabony defects Reference

    Horizontal bone loss

    • Detection of periodontal bone loss patterns from OPGs using AI. “For horizontal bone losses” part under the “Ground truth” heading consists the detection logic of the horizontal bone loss Reference

    Calculus

    • Radiographic Detection of Dental Calculus Reference

    PDL widening

    • Description of pdl widening and common conditions associated with it Reference

    Peri implantitis

    • Radiographic description of periimplantitis under the heading “Radiographic signs associated with failing endosseous implants” Reference
    • Detailed calculation of the marginal bone loss around the implants Reference

    Lesion

    • Radiographic approach for jaw lesions Reference
    • Radiological aspects of apical periodontitis Reference
    • Various lesions and their radiographic appearances on panoramic radiographs Reference

    Jaw fracture

    • Mandibular Fractures and their Radiographic Diagnosis Reference
    • Midfacial fractures in OPGs Reference

    Elongated Styloid process

    • Evaluation of the styloid process on panoramic radiographs Reference

3. Accessibility of Sources

Each potential pathology detected by the Software is associated with a specific reference or set of references that be accompanied by the relevant clinical guidelines or radiographic characteristics that the Software’s logic has been informed by to produce the relevant outputs. These references are:

  1. Integrated into the Software

    The Software will, upon detection of a possible pathology, display the relevant clinical guideline or study reference or otherwise make it accessible to the health professional in the form of a hyperlink embedded within the Software's user interface.

  2. Included in Documentation

    The Software's accompanying documentation include a section dedicated to explaining the clinical basis for each type of potential pathology detected, citating the relevant guiding literature and guidelines.

These references allow healthcare professionals to use the Software output to make informed clinical decisions by facilitating their independent verification of the underlying clinical guidelines and evidence used to inform the Software’s logic.

4. Independence in Professional Judgment

The Software is designed to support health professionals in their decision-making process without replacing their judgment. The responsibility for any clinical decision rests with the health professional, who may consider the Software's output in their decision-making process:

  1. Design for Decision Support Rather Than Replacement

    The Software aids health professionals in their decision-making process. It is a tool for decision support, not a substitute for a health professional’s judgement.

  2. Implement Recommendations Based on Clinical Guidelines

    The Software provides recommendations to health professionals based on independently verifiable clinical guidelines, ensuring they are evidence-based up to the date the Software was made available.

  3. Facilitate Verification of Software Recommendations

    The Software facilitates health professionals to verify the Software’s recommendations according to identified clinical guidelines.

These references allow healthcare professionals to use the Software output to make informed clinical decisions by facilitating their independent verification of the underlying clinical guidelines and evidence used to inform the Software’s logic.

5. Transparent Updates and Revisions

Recognising the dynamic nature of clinical practice and guidelines, the Software incorporates a transparent change log made available to healthcare professionals to track updates and understand their implications on the Software's recommendations against the latest research and clinical guidelines.

  1. Implement and Document Updates

    Any updates to the Software is managed within our Change Management processes, which include providing detailed documentation and transparent change logs for any changes to reflect new clinical research and updated guidelines.

  2. Communication Plan

    Users will be informed about any Software updates, including changes made and their implications, in accordance with our communication plan.

6. Adherence to Life Cycle Requirements for Medical Device Software

The Software adheres to the framework for the life cycle processes of medical device software (IEC 62304). This includes safety, performance and verification criteria including software planning, requirements analysis, architecture design, testing, release and change management, and maintenance.

  1. Software Development Planning

    Development tasks are planned and executed according to defined releases. This includes incorporating Quality Management and Risk Management systems and processes (ISO 13485, ISO 14971).

  2. Software Requirements Analysis

    This encompasses the detailed definition of software requirements, ensuring traceability, and establishing acceptance criteria for testability.

  3. Software Architecture Design

    The architecture for the Software is designed, developed, and documented in adherence to best practice frameworks such as the AWS Well-Architected Framework.

  4. Software Testing

    A built-in workflow covers end-to-end quality management, including integration, system, and user acceptance testing, with documented results.

  5. Software Release

    Updates and changes are comprehensively documented with each release.

  6. Software Configuration/Change Management

    Configuration items are meticulously documented, and changes are controlled through a robust change management process.

  7. Software Maintenance

    Software maintenance activities are regularly planned and executed, including the frequent re-assessment of risks.