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

Sponsor
Al-Azhar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05281861
Collaborator
(none)
48
2
13

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Zirconia reinforced Lithium disilicate (Vita Ambria) ceramic onlay restoration
  • Other: Lithium disilicate (IPS e-max press) ceramic onlay restoration
N/A

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 are evaluated by a blind and calibrated two examiner using the FDI (World Dental Federation) criteria. A total of 24 patients will be randomly assigned to each group for a total of 48 patients. 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 Onlay preparation . Vinylpolysiloxane impression will be taken, wax pattern for the 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 onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions. Primary outcome: Marginal adaptation will be evaluated according to FDI standard.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double blinded (Patient and outcome assessors)
Primary Purpose:
Treatment
Official Title:
Evaluation of Marginal Adaptation of Onlay Restorations Constructed From Two Types of Glass Ceramics: A Randomized Clinical Trial
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Marginal Adaptation [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.

Secondary Outcome Measures

  1. Restoration Fracture and retention [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.

  2. Effect of the restoration on the periodontium [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.

  3. Tooth cracks and fractures [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Walid Awad Abdelhady, Assistant Lecturer, Department of Crown and Bridge, Al-Azhar University, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05281861
Other Study ID Numbers:
  • Margin of Vita Ambria GC
First Posted:
Mar 16, 2022
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Walid Awad Abdelhady, Assistant Lecturer, Department of Crown and Bridge, Al-Azhar University, Al-Azhar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022