Evaluation Of Zirconia Crowns Restoring Endodontically Treated Posterior Teeth With Two Finish Line Designs And Occlusal Reduction Schemes
Primary Purpose
Gingival Inflammation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Abutment with flat occlusal reduction with feather edge finish
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Inflammation focused on measuring Zirconia,, occlusal scheme,, endodontically treated teeth,, finishline designs.
Eligibility Criteria
Inclusion Criteria:
- From 21-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or periapical diseases.
- Psychologically and physically able to withstand conventional dental procedures.
- Maintenance of good oral hygiene.
- Patients with teeth problems indicated for single posterior crowns:
- Badly decayed teeth
- Sufficient occluso-gingival tooth height
- Endodontically treated teeth
- No tooth mobility or grade 1 can be accepted.
- No furcation involvement.
- Able to return for follow-up examinations and evaluation.
Exclusion Criteria:
- Patients with defective root canal treatment
- 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
- Lack of opposing dentition in the area of interest
- Patients with bruxism.
Sites / Locations
- Faculty of Dentistry, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
flat occlusal reduction with feather edge finish
flat occlusal reduction with shoulder finish line
planar occlusal reduction with shoulder finish line
Arm Description
Outcomes
Primary Outcome Measures
clinical performance in terms of the marginal adaptation of the groups
examination will follow the USPHS criteria.
Secondary Outcome Measures
the fracture of the restoration
examination will follow the USPHS criteria.
marginal discoloration
examination will follow the USPHS criteria.
secondary caries
examination will follow the USPHS criteria.
gingival response
examination will follow the gingival index criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04052490
Brief Title
Evaluation Of Zirconia Crowns Restoring Endodontically Treated Posterior Teeth With Two Finish Line Designs And Occlusal Reduction Schemes
Official Title
Evaluation Of Zirconia Crowns Restoring Endodontically Treated Posterior Teeth With Two Finish Line Designs And Occlusal Reduction Schemes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the clinical performance of two finish line designs (feather edge and rounded shoulder) in relation with two occlusal designs (flat and planar) in endodontically treated teeth restored with zirconia crowns.
Detailed Description
Several studies have been investigating the effect of preparation design and its relation to the marginal adaptation. Habib et al 2014 compared the accuracy of marginal and internal adaptation of zirconia copings fabricated on anatomic (A), semi-anatomic (SA) and non-anatomic (NA) occlusal surface preparations. The internal & marginal fit were measured under electron microscope at 9 standardized areas .The anatomical occlusal preparation had better marginal and internal adaptation of Zr copings. Lima et al 2018 studied the influence of two different occlusal preparation designs on the marginal adaptation of CAD-CAM onlay restorations. The conventional anatomical occlusal preparation with a 1.2-mm modified shoulder finish line extending on the buccal surface and modified preparation flat cuspal reduction without shoulder finish line. The results showed that the conventional anatomical occlusal preparation had significantly better marginal adaptation than that of the flat cuspal preparation. Succeeding these studies, it was of interest to investigate whether or not the occlusal scheme could influence the marginal accuracy of the CAD/CAM crowns fabricated with Zirconia ceramic material.
Studies correlating between the finish line design and occlusal scheme in literature are scarce, with little evidence regarding their effect on precision fit properties of restorations. Abdullah et al 2017 evaluated the effect of using different finishing line designs with different occlusal surface reduction schemes on the vertical marginal fit of full contour CAD/CAM zirconia crown restorations. They found a direct correlation between both the finish line geometry and the occlusal design. In recent literature, the use of feather edge finish line with all ceramic restorations is a point of conflict. Fuzzi et al 2017 studied the nanoleakage and internal adaptations of lithium disilicate and zirconia crowns with featheredge finish lines. They recommended only zirconia with this finish line configuration due to its high fracture resistance when used in thin sections. Thus, the current study was conducted to examine this finish line effect on the marginal precision fit. Our hypothesis is there will be no difference in the clinical performance between the flat occlusal scheme with feather edge or rounded shoulder finish line and the planar occlusal scheme with rounded shoulder finish line configuration.
The rationale for carrying out the trial:
The influence of different tooth preparation designs can affect the success of the full coverage restorations. Still, there is no available research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Inflammation
Keywords
Zirconia,, occlusal scheme,, endodontically treated teeth,, finishline designs.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flat occlusal reduction with feather edge finish
Arm Type
Experimental
Arm Title
flat occlusal reduction with shoulder finish line
Arm Type
Experimental
Arm Title
planar occlusal reduction with shoulder finish line
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Abutment with flat occlusal reduction with feather edge finish
Other Intervention Name(s)
Experimental: Abutment with flat occlusal reduction with shoulder finish line
Intervention Description
Non vital teeth require a full coverage restoration to withstand the functional stresses and prevent any further destruction of tooth/crown complex. The zirconia all-ceramic crowns yield a high flexure strength and are used as an esthetic alternative to ceramo-metallic crowns. Several studies linked the effect of preparation designs to the survival of the restoration. Others, studied the effect of the finish line geometries as deep chamfer and shoulder on the marginal integrity of restorations. The feather edge finish line is used with zirconia crowns with limited data regarding its success. However, there is no presented research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns.
Primary Outcome Measure Information:
Title
clinical performance in terms of the marginal adaptation of the groups
Description
examination will follow the USPHS criteria.
Time Frame
One-Year
Secondary Outcome Measure Information:
Title
the fracture of the restoration
Description
examination will follow the USPHS criteria.
Time Frame
One-year
Title
marginal discoloration
Description
examination will follow the USPHS criteria.
Time Frame
One-year
Title
secondary caries
Description
examination will follow the USPHS criteria.
Time Frame
One-year
Title
gingival response
Description
examination will follow the gingival index criteria
Time Frame
One-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
From 21-50 years old, be able to read and sign the informed consent document.
Have no active periodontal or periapical diseases.
Psychologically and physically able to withstand conventional dental procedures.
Maintenance of good oral hygiene.
Patients with teeth problems indicated for single posterior crowns:
Badly decayed teeth
Sufficient occluso-gingival tooth height
Endodontically treated teeth
No tooth mobility or grade 1 can be accepted.
No furcation involvement.
Able to return for follow-up examinations and evaluation.
Exclusion Criteria:
Patients with defective root canal treatment
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
Lack of opposing dentition in the area of interest
Patients with bruxism.
Facility Information:
Facility Name
Faculty of Dentistry, Cairo university
City
Cairo
State/Province
Manial
ZIP/Postal Code
17928
Country
Egypt
12. IPD Sharing Statement
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Evaluation Of Zirconia Crowns Restoring Endodontically Treated Posterior Teeth With Two Finish Line Designs And Occlusal Reduction Schemes
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