A I in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With 2 Ceramic Materials

Application of Artificial Intelligence in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With Two Ceramic Materials

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)

Study Overview

• Status: Recruiting
• Conditions: Artificial Intelligence
• Intervention / Treatment: Other: change in restoration material and margin design.

Detailed Description

The objective of the present study is to characterize two different margin designs (vertical "feather-edge" and horizontal "shoulder") with two different ceramic materials (zirconia and hybrid ceramic) in terms of clinical performance, marginal fit and fracture resistance.

Primary outcome:

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.

Secondary outcome:

Evaluating the 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).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: walaa tarek ElHefnawy, PHD; Phone Number: 01018527239 / 01203209613; Email: walaatarek94@gmail.com

Study Locations

• Egypt
  • Al-Azhar University
    • Cairo, Al-Azhar University, Egypt, 02
      • Recruiting
      • Walaa Tarek El Hefnawy
      • Contact: walaa tarek el hefnawy, PHD; Phone Number: 01018527239 / 01203209613; Email: walaatarek94@gmail.com
      • Contact: Mona hossam, professor; Phone Number: 01112201755; Email: drmonahossam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (I); Patients will be prepared with vertical "feather edge" margin design.	Other: change in restoration material and margin design.; comparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results; Other Names: Predicting the follow up results using the new (artificial intelligence "AI") model
Experimental: Group (II); Patients will be prepared with horizontal "shoulder" margin design.	Other: change in restoration material and margin design.; comparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results; Other Names: Predicting the follow up results using the new (artificial intelligence "AI") model
Experimental: Subgroup (A); Patients will receive zirconia ceramic crowns	Other: change in restoration material and margin design.; comparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results; Other Names: Predicting the follow up results using the new (artificial intelligence "AI") model
Experimental: Subgroup (B); Patients will receive hybrid ceramic crowns.	Other: change in restoration material and margin design.; comparing two different materials and two different designs. use artificial intelligence in the prediction of follow up results; Other Names: Predicting the follow up results using the new (artificial intelligence "AI") model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-Vitro Study preparations.	Marginal Adaptation "feather-edge" versus horizontal "shoulder" margin designs fabricated with two ceramic materials (zirconia and hybrid ceramic).	6 months
In-Vitro Study	Fracture Resistance	6 months
In-Vivo Study	Clinical Examination	Baseline,3 months,6 months

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P-CR-23-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No