Marginal Evaluation of Zirconia Reinforced Lithium Disilicate Partial Coverage Restoration of Egyptian Posterior Teeth.

January 29, 2024 updated by: Walid Awad Abdelhady, Al-Azhar University

Evaluation of Marginal Adaptation of Onlay Restorations Constructed From Two Types of Glass Ceramics: A Randomized Clinical Trial

Objective: To evaluate the marginal adaptation of the zirconia reinforced lithium disilicate (VITA AMBRIA) glass ceramic Inlay/Onlay compared with lithium disilicate(IPS emax Press) glass ceramic Inlay/Onlay in decayed posterior teeth.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations will be evaluated by a blind and calibrated two examiner using the FDI (World Dental Federation) criteria. A total of 25 subject will be randomly assigned to each group for a total of 50 subject. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.

Both groups will receive Inlay/Onlay preparation . Digital impression will be taken, wax pattern for the Inlay/Onlay restoration will be designed and milled using CAD/CAM(computer-aided design/computer-aided manufacturing) software. After that, the wax pattern will be invested and final Inlay/Onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Al-Azhar University (Cairo)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The patient is healthy.
  • 18-50 years old.
  • Normal occlusion.
  • Good oral hygiene.
  • Tooth with complete root apex.
  • Tooth with moderate coronal decay.

Exclusion Criteria:

  • Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration
The onlays will be constructed from Zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic system
Other: Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration
In experimental group, Participants will be restored with onlay ceramic restorations constructed from zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic
Active Comparator: Lithium disilicate (IPS e-max press) ceramic onlay restoration
The onlays will be constructed from Lithium disilicate (IPS e-max press) glass ceramic system
Other: Lithium disilicate (IPS e-max press) ceramic onlay restoration
In control group, Participants will be restored with onlay ceramic restorations constructed from Lithium disilicate (IPS e-max press) glass ceramic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Adaptation
Time Frame: 1 year follow up

Measuring device: visual and probe.

According to FDI standard(Grade 1-5), which has been defined as follows:

Grade 1. Harmonious outline, no gaps, no white or discolored lines. Grade 2. Marginal gap (> 50 μm and < 150 μm), white lines; small marginal fracture removable by polishing; slight ditching, slight step /flashes, minor irregularities Grade 3. Gap (> 150 μm and < 250 μm) not removable; several small marginal fractures; major irregularities, ditching or flash, steps.

Grade 4. Gap (> 250 μm) dentine/base exposed, chip fracture damaging margins, Notable enamel, or dentine wall fracture.

Grade 5. Restoration is loose but in situ.
1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration Fracture and retention
Time Frame: 1 year follow up

Fracture and retention of the onlay restoration will be evaluated. Measuring device: visual and probe.

According to FDI standard (Grade 1-5), which has been defined as follows:

Grade 1: Restoration is present with no fractures, cracks or chipping. Grade 2:Small hairline cracks are visible. Grade 3:Several hairline cracks are present and/or limited chipping of material without damage to marginal quality or proximal contacts.

Grade 4: Fractures affect marginal quality and/or proximal contacts; bulk fractures with probable gap > 250 μm with or without partial loss of less than half the restoration.

Grade 5:Loss of restoration or bulk fracture with probable gap > 250 μm with partial loss of the restoration.
1 year follow up
Effect of the restoration on the periodontium
Time Frame: 1 year follow up

inflammation will be evaluated. Measuring device: visual and probe according to

FDI standard (Grade 1-5), which has been defined as follows:

Grade 1: No plaque, no inflammation of the gingival papilla. Grade 2: Minimal plaque is present, PBI equivalent to baseline. Grade 3: Difference up to one grade in severity of PBI compared to baseline and in comparison to control tooth.

Grade 4: Difference of more than one grade of PBI worsening in comparison to control tooth or increase in pocket depth > 1 mm requiring major intervention.

Grade 5: Severe/ acute gingivitis or periodontitis if related to the restoration requiring immediate replacement of the restoration.
1 year follow up
Tooth cracks and fractures
Time Frame: 1 year follow up

Measuring device: visual and probe according to FDI standard (Grade 1-5) Grade 1: Complete integrity of the restored tooth. Grade 2: Minor marginal crack < 150 μm wide or a hairline crack which cannot be probed. The patient has no clinical symptoms.

Grade 3:

(Grade 3.1) Marginal split in the enamel < 250 μm wide. Not possible to remove by polishing without compromising the shape of the tooth surface or damaging the tooth and is left untreated as not expected to cause further damage. (Grade 3.2)Crack < 250 μm. Patient has no or minimal discomfort.

Grade 4:

(Grade 4.1) Major marginal split > 250 μm that requires repair and/or dentin or base exposed . (Grade 4.2):A 250-μm probe/explorer can be inserted into a crack Grade 5: A cusp or major tooth fracture requiring immediate replacement.
1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Director: Mohamed FA Metwally, BDS, Lecturer of Crown and Bridge Faculty of Dental Medicine, Al-Azhar University
  • Study Chair: . Khaled MO Haggag, Professor, Professor of Crown and Bridge Faculty of Dental Medicine, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V.Ambria Adaptation(679/272)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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