NCT07099261

Brief Summary

This clinical research aims to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed by Traditional Design Software The research will be conducted on a sample of patients with an indication for crowning of the first lower molar. Ten dental crowns will be prepared. After obtaining written consent from patients who meet the inclusion and exclusion criteria, 10 dental crowns will be prepared. Measurements will be taken using silicone impressions and then converted into digital format. The digital impression will be sent to the selected dental restoration design software used in the study. The same parameters will be adjusted in all software programs for each crown. After the design is completed, the designs will be sent to the milling unit. For each case, three crowns will be designed and milled from polymethyl methacrylate (PMMA). The crown will be clinically examined and evaluated according to specific criteria. Marginal fit, proximal contact quality, and occlusion will be assessed. The best crown will be milled from zirconia and delivered to the patient.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2025

Status
not yet 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 Progress65%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

July 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

July 20, 2025

Last Update Submit

July 25, 2025

Conditions

Keywords

CrownsCrowns Designed by Artificial IntelligenceArtificial intelligence(AI)CADCAD\CAMcomputer-aided design and computer-aided manufacturingprosthesis

Outcome Measures

Primary Outcomes (3)

  • Marginal Fit

    Evaluation is conducted by 2 dentists to determine whether the restoration is clinically acceptable or unacceptable using an explorer or The silicone replica technique (Silicone Replica Technique) is used to evaluate the marginal fit of crowns using silicone material or Evaluation is conducted using Geomagic X

    immediately after delivering the crown

  • Clinical evaluation of proximal contact points

    To evaluate the interproximal contact points of the crown clinically using waxed dental floss: if the floss passes with slight resistance, the contact points are considered acceptable if the floss passes without resistance, the contact points are considered unacceptable if the floss hard to pass or tearing, the contact points are considered Tight Contact

    immediately after delivering the crown

  • clinical evaluation of the occlusion

    Clinical Evaluation of Occlusion Using Articulating Paper Excellent (both 100- and 12-mm articulating paper imprints exist on the crown and adjacent teeth) nice occlusal contact distribution Good (only 100-mm articulating paper imprints exist on adjacent teeth) Individual occlusal contact points missing or deviated but occlusal contacts on main supporting cusp Satisfactory crown too high, thus supra occlusion No occlusal contacts on supporting cusps but contacts present on other parts of occlusal surface Unsatisfactory No occlusal contact points on crown(infra occlusion)

    immediately after delivering the crown

Study Arms (3)

Crowns designed with AI powered dentibird

EXPERIMENTAL

10 Crowns designed with AI powered dentbird

Other: Crowns

Crowns designed with AI powered Exocad

EXPERIMENTAL

10 Crowns designed with AI powered Exocad

Other: Crowns

Crowns designed with conventional Exocad

SHAM COMPARATOR

10 Crowns designed with conventional Exocad (computer aided experienced)

Other: Crowns

Interventions

CrownsOTHER

1. Tooth Preparation: Prepare the teeth to receive a zirconia crown. 2. Impression Taking: Obtain impressions using silicone. 3. Digital Conversion: Convert impressions into a digital model using a laboratory scanner. 4. Design Submission: Send the digital model to selected crown design program. 5. Crown Fabrication: crowns designed will be produced from PMMA using a milling unit. 6. Clinical Evaluation: Conduct a clinical assessment of the crowns 7. the best crown design will be milled from zirconia and delivered Evaluation of Crowns designed by following metrics: 1. Marginal fit 2. proximal contact 3. Occlusion

Also known as: dental crowns
Crowns designed with AI powered ExocadCrowns designed with AI powered dentibirdCrowns designed with conventional Exocad

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-60 years requiring a crown for a lower first molar
  • Good oral and gingival health
  • adjacent teeth in good condition
  • Natural opposing teeth
  • Willingness to participate and sign informed consent

You may not qualify if:

  • Abnormal occlusal habits such as bruxism
  • Active periodontal diseases
  • Allergy to crown materials (e.g., polymethyl methacrylate, PMMA)
  • Poor oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Crowns

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Zeyad Handhal, master's student

    Tishreen University

    PRINCIPAL INVESTIGATOR
  • Rima Saker, Assistant professor

    Tishreen University

    STUDY CHAIR

Central Study Contacts

Zeyad Handhal, master's student

CONTACT

Rima Saker, Assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: self controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2025

First Posted

August 1, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07