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Completed

NCT Number: NCT07834957

Clinical Evaluation of AI-Driven Designed Single Crowns

This clinical study compares tooth-supported single crowns designed by a dental technician and by an artificial intelligence (AI) driven automated design method. The two design methods are qualitatively compared in terms of buccal and lingual/palatal contours, proximal and occlusal contacts, and marginal fit using clinical evaluation. The two design methods are quantitatively compared in terms of global, buccal, and lingual/palatal surface deviations using three-dimensional surface deviation analysis.

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Key information

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry, Department of Prosthodontics

Ankara, 06100, Turkey (Türkiye)

About this study

This methodological clinical study evaluates tooth-supported single crowns produced using two different digital design methods within a fully digital workflow. For each participant, two crown restorations are designed for the same prepared posterior tooth: one by an experienced dental technician using conventional computer-aided design (CAD) software and the other using an artificial intelligence (AI)-driven automated design system. Both restorations are produced using the same manufacturing workflow and are clinically evaluated under standardized conditions.

The two restorations are evaluated for buccal and lingual/palatal crown contours, mesial and distal proximal contacts, occlusal contacts, and marginal adaptation using predefined clinical criteria. In addition, three-dimensional (3D) surface deviation analysis is performed to quantitatively compare the two design methods at the global, buccal, and lingual/palatal surface levels.

The study uses a within-participant comparison design, with both design methods evaluated on the same prepared tooth, thereby minimizing variability related to patient- and tooth-specific factors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of written informed consent to participate in the study
  • Adults aged 20-39 years
  • Good general and local periodontal health with adequate oral hygiene
  • Indication for a single full-coverage crown restoration in the posterior region
  • Asymptomatic abutment tooth on clinical examination
  • No periradicular radiolucency associated with the abutment tooth on periapical radiographic examination
  • Sufficient remaining tooth structure without the need for a post-and-core restoration, allowing preservation of at least three axial walls after preparation, achievement of a ferrule with at least 1 mm of sound tooth structure coronal to the gingival level, and standardized finish-line preparation
  • Presence of intact natural teeth or restorations mesial and distal to the abutment tooth and an opposing tooth or restoration allowing establishment of occlusal contact
  • Stable interarch occlusal relationship
  • No parafunctional habits

Exclusion criteria

  • Refusal to provide written informed consent
  • Serious systemic disease or condition that may contraindicate or interfere with tooth preparation and restorative treatment, including steroid therapy, uncontrolled diabetes mellitus, immunological disorders, pregnancy, or conditions preventing adequate cooperation
  • Systemic or local risk factors that may affect the treatment process, including active periodontal disease or inadequate oral hygiene
  • History of allergy to local anesthetics containing epinephrine
  • Functional or muscular temporomandibular disorders limiting mouth opening
  • Parafunctional habits such as bruxism

Treatment and study plan

Dental Technician Crown Design

Device

Single-crown restorations were designed by an experienced dental technician using 3Shape Dental System based on intraoral scan data. The restorations were designed using predefined contact parameters and a standardized CAD morphology library.

AI-Driven Automated Crown Design

Device

Single-crown restorations were automatically designed for the same prepared teeth using the AI-driven 3Shape Automate platform based on intraoral scan data. The restorations were designed using contact parameters and a CAD morphology library standardized to those used in the dental technician design method.

Primary outcomes

  1. Clinical Evaluation of Buccal and Lingual/Palatal Crown Contours

    Time frame: Day 1

    Dental technician-designed and AI-driven restorations are clinically evaluated for buccal and lingual/palatal crown contours using modified California Dental Association (CDA) criteria. Buccal and lingual/palatal surfaces are scored separately, and the scoring system distinguishes overcontour from undercontour.

  2. Clinical Evaluation of Proximal Contacts

    Time frame: Day 1

    Dental technician-designed and AI-driven restorations are clinically evaluated for mesial and distal proximal contacts using modified California Dental Association (CDA) criteria. Mesial and distal contacts are scored separately for each restoration.

  3. Clinical Evaluation of Occlusal Contacts

    Time frame: Day 1

    Dental technician-designed and AI-driven restorations are clinically evaluated for occlusal contacts using modified California Dental Association (CDA) criteria. Occlusal contacts are scored for each restoration using the predefined ordinal scoring system.

  4. Clinical Evaluation of Marginal Adaptation

    Time frame: Day 1

    Dental technician-designed and AI-driven restorations are clinically evaluated for marginal adaptation using modified California Dental Association (CDA) criteria. Marginal adaptation is scored for each restoration using the predefined ordinal scoring system.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of Tooth-Supported Single-Crown Restorations Produced With Artificial Intelligence-Driven Design in a Fully Digital Workflow: A Clinical Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 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.

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