Evaluation of Marginal, Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano Hybrid and Lithium Di-silicate Ceramic Materials.

Evaluation of Marginal and Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano-ceramic Hybrid and Lithium Di-silicate Ceramic Materials (A Randomized Controlled Clinical Trial)

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Fit and Clinical Performance
• Intervention / Treatment: Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown

Detailed Description

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Primary outcome: Marginal gap of the two groups will be measured using Silicon replica technique, Each replica will be sectioned bucco-lingually and mesio-distally into four segments named (MB, DB, ML, DL) and each segment has five reference points assigned at different positions, An overall of twenty reference points will be measured in each replica sample using a digital microscope.

Secondary outcome:

• Internal gap of the two groups will be measured using Silicon replica technique, which will be measured by digital microscope.
• Clinical Performance of the two groups will be evaluated using modified USPHS scoring system. (Color match, Marginal discoloration, Surface texture and Gross fracture)

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• From 18-50 years old, be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases, have teeth with good restorations.
• Psychologically and physically able to withstand conventional dental procedures.
• Patients planned for a single coverage restoration in the posterior area.
• Able to return for follow-up examinations and evaluation.
• Patients have root apex of molar without evident damage and no root fracture.
• Good oral hygiene habits.
• Have a complete root canal therapy molar necessitating an Endo-crown restoration.

Exclusion Criteria:

• Patient less than 18 or more than 50 years
• Patients with severe clenching or bruxism.
• Patient with active resistant periodontal diseases
• Patients with poor oral hygiene and uncooperative patients
• Pregnant women
• Patients in the growth stage with partially erupted teeth
• Psychiatric problems or unrealistic expectations
• Patients with inadequate or low quality endodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nano-ceramic hybrid (Grandio Blocs) Endo-crown.; Nano-ceramic hybrid ( intervention)	Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown; Nano-ceramic hybrid
Active Comparator: Lithium di-silicate Ceramic (E.max CAD blocks) Endo-crown; Lithium di-silicate Ceramic ( Control)	Procedure: Nano-ceramic hybrid (Grandio Blocs) Endo-crown; Nano-ceramic hybrid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal and internal gap evaluation	marginal and internal gap will be evaluated by silicon replica technique, each replica will be sectioned into four segments named (MB, DB, ML, DL) and each segment had five reference points assigned at different positions, an overall of twenty reference points will be measured in each replica sample using a digital microscope. The measuring unit by microns	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical performance(Color match, Marginal discoloration, Surface texture and Gross fracture)	Clinical performance will be measured by modified USPHS criteria and the measuring unit by Alpha (A), Bravo (B) and Charlie (C)	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 191020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

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