NCT07562607

Brief Summary

This clinical research validates a fully automatic AI algorithm for dental crown design using GANs trained on University of Hong Kong 3D prosthesis data and AI-powered FEA for stress correction, overcoming CAD/CAM limitations like manual technician time and occlusal errors. In-vitro fatigue tests confirmed performance comparable to conventional crowns. Clinically, AI-designed crowns are compared to technician CAD/CAM controls using 10 FDI criteria (aesthetic/functional/biological), assessed via oral exams, and IOS (wear), to prove feasibility and optimize the algorithm.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Sep 2022Jan 2027

Study Start

First participant enrolled

September 5, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

May 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Tooth Defect

Keywords

Artificial IntelligenceClinical EvaluationComputer-aided designSingle-unit dental restorationdental crown

Outcome Measures

Primary Outcomes (1)

  • Fracture of material or tooth and loss of retention

    Primary outcome variables are the fracture of material or tooth and loss of retention. These major failures (graded as "Clinically poor - replacement necessary" on FDI criteria) are assessed by oral examination and IOS for detection of fractures, cracks, or debonding.

    12 months (baseline + 6, 12months post-cementation)

Study Arms (2)

AI-designed crowns

EXPERIMENTAL

Participants receive single-unit dental crowns automatically designed by a fully AI-based algorithm using Generative Adversarial Networks (GAN) trained on 3D clinical prosthesis data from the University of Hong Kong.

Device: AI-Designed Dental Crowns

Conventional CAD/CAM Dental Crowns

ACTIVE COMPARATOR

Participants receive single-unit dental crowns designed manually by experienced dental technicians using standard computer-aided design and computer-aided manufacturing (CAD/CAM) software and workflow (current standard of care).

Device: Conventional CAD/CAM Dental Crowns

Interventions

Conventional CAD/CAM Dental CrownsDEVICE

Single-unit dental crowns designed manually by experienced dental technicians using standard CAD software and fabricated using computer-aided manufacturing (CAM) methods (milling or 3D printing). This represents the current standard-of-care digital workflow for dental restorations.

Conventional CAD/CAM Dental Crowns
AI-Designed Dental CrownsDEVICE

Single-unit dental crowns automatically designed by a fully AI-based algorithm using Generative Adversarial Networks (GAN) trained on 3D dental prosthesis datasets from the University of Hong Kong.

AI-designed crowns

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female patients (aged 18-60 years old) attending the HKU Faculty of Dentistry teaching clinic in Prince Philip Dental Hospital (PPDH), who are in need of single crown restorative treatment in the posterior region.

You may not qualify if:

  • female patients with pregnancy; patients with any systemic diseases (e.g., uncontrolled diabetes, uncontrolled hypertension, uncontrolled osteoporosis, etc); patients with history of local irradiation therapy; patients with untreated periodontal diseases or poor oral hygiene; patients with severe bruxism or clenching habits; patients with periapical lesions in the treated teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentisry, the University of Hong Kong

Hong Kong, 000000, Hong Kong

Location

Related Publications (2)

  • Ding H, Cui Z, Maghami E, Chen Y, Matinlinna JP, Pow EHN, Fok ASL, Burrow MF, Wang W, Tsoi JKH. Morphology and mechanical performance of dental crown designed by 3D-DCGAN. Dent Mater. 2023 Mar;39(3):320-332. doi: 10.1016/j.dental.2023.02.001. Epub 2023 Feb 21.

    PMID: 36822895BACKGROUND

  • Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

    PMID: 20628774BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

September 5, 2022

Primary Completion

December 7, 2025

Study Completion (Estimated)

January 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-03

Locations

HK(1)