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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06164002
Other study ID # P-CR-23-04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date July 15, 2024

Study information

Verified date December 2023
Source Faculty of Dental Medicine for Girls
Contact walaa tarek ElHefnawy, PHD
Phone 01018527239 / 01203209613
Email walaatarek94@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Walaa Tarek El Hefnawy Cairo Al-Azhar University

Sponsors (1)

Lead Sponsor Collaborator
Faculty of Dental Medicine for Girls

Country where clinical trial is conducted

Egypt, 

Outcome

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