NCT06164002

Brief Summary

The present study will be performed to evaluate application of artificial intelligence in the prediction of clinical performance, marginal fit and fracture resistance of vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic)

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

August 16, 2023

Last Update Submit

February 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Artificial intelligence application assessment, laboratory marginal fit and fracture resistance

    Predicting the follow up results using the new (artificial intelligence "AI") model for vertical "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic) that saves the clinical evaluation period, hence saves the expenses of the dental clinic.

    6 months

Secondary Outcomes (3)

  • In-Vitro Study preparations.

    6 months

  • In-Vitro Study

    6 months

  • In-Vivo Study

    Baseline,3 months,6 months

Study Arms (4)

Group (I)

EXPERIMENTAL

Patients will be prepared with vertical "feather edge" margin design.

Other: change in restoration material and margin design.

Group (II)

EXPERIMENTAL

Patients will be prepared with horizontal "shoulder" margin design.

Other: change in restoration material and margin design.

Subgroup (A)

EXPERIMENTAL

Patients will receive zirconia ceramic crowns

Other: change in restoration material and margin design.

Subgroup (B)

EXPERIMENTAL

Patients will receive hybrid ceramic crowns.

Other: change in restoration material and margin design.

Interventions

comparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results

Also known as: Predicting the follow up results using the new (artificial intelligence "AI") model
Group (I)Group (II)Subgroup (A)Subgroup (B)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age range of patients should be 20-50 years old, able to read and sign the informed consent document. 2. Patient with posterior molars indicated for full coverage restorations. 3. Patient should be able to physically and psychologically tolerate conventional restorative procedures. 4. Patients who are willing to return for follow-up examination and evaluation. 5. Indicated molar should have adequate tooth preparation length to ensure proper retention and resistance form. 6. Patient with sound contralateral or adjacent tooth to the selected tooth requiring full coverage restoration.

You may not qualify if:

  • Patient in the growth stage with partially erupted teeth.
  • Patient with poor oral hygiene and motivation.
  • Pregnant women.
  • Patient with psychiatric problems or unrealistic expectations.
  • Patients with no opposing occluding dentition in the area intended for restoration.
  • Patients with parafunctional habits. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Tarek El Hefnawy

Cairo, Al-Azhar University, 02, Egypt

Location

MeSH Terms

Interventions

Artificial IntelligenceModels, Biological

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical ConceptsModels, TheoreticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

August 16, 2023

First Posted

December 11, 2023

Study Start

September 1, 2023

Primary Completion

September 15, 2024

Study Completion

May 15, 2025

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations