Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns

Study Overview
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Brief Summary
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The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic system compared to partial coverage restorations fabricated with lithium disilicate ceramic system.

Detailed Description
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This study is constructed to assess in patients with carious vital posterior teeth whether the use of Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate partial coverage restorations will result in higher survival rates and better patient related outcome scores compared to IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate partial coverage restorations.

Official Title
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Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns: A Randomized Controlled Clinical Trial

Conditions
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Partial Coverage Restoration

Intervention / Treatment
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* Other: Vita Suprinity
* Other: IPS e.max


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants: Good oral hygiene, papillary bleeding index (PBI) < 35%. Positive patient acceptance to participate in the trial. Teeth: Carious class II or MOD lesions Vital upper or lower posterior teeth with no signs of irreversible pulpitis. Normal occlusion Single tooth restoration (no edentulous space that requires fixed prosthesis) Exclusion Criteria: Participants Pregnancy. Disabilities. Systemic disease or severe medical complications. Bad oral hygiene Heavy smoking. Xerostomia. Lack of compliance. Evidence of severe bruxism, clenching, or temporomandibular disorders. Teeth: Deep carious defects (close to pulp, less than 1 mm distance). Periapical pathology or signs of pulpal pathology. Tooth hypersensitivity. Rampant caries. Non-vital or endodontically treated teeth. Sever periodontal affection. Tooth mobility

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: split-mouth design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprinity<br>Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate PCRs | Other: Vita Suprinity<br>* zirconia reinforced lithium silicate partial coverage restorations<br>|
| Active Comparator: e.max<br>IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate PCRs | Other: IPS e.max<br>* lithium disilicate partial coverage restorations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Absolute failure is defined by clinical unacceptable fracture and crack development which required a replacement of the entire restoration, and/or secondary caries as well as endodontic complications | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restorations with Marginal gap as assessed visually by US public health service criteria | restorations with visually detectable margin, catch or penetration of explorer at baseline or a change from baseline on visual analogue scale at 12 month | 12 month | 
| Restorations with Marginal discoloration as assessed visually by US public health service criteria | restorations with visually detectable discoloration along margin at baseline or a change from baseline on visual analogue scale at 12 month | 12 month | 
| Restorations with color mismatch with adjacent teeth as assessed visually by US public health service criteria | restorations with visually detectable color mismatch with adjacent teeth at baseline or a change from baseline on visual analogue scale at 12 month | 12 month | 
| Restorations with surface roughness as assessed tactilely by US public health service criteria | restorations with tactilely detectable rough surface at baseline or a change from baseline on visual analogue scale at 12 month | 12 month | 
| Restorations developed secondary caries as assessed visually by US public health service criteria | restorations with visually detectable secondary caries at baseline or a change from baseline on visual analogue scale at 12 month | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial coverage restoration, Crown, Posterior teeth, All ceramic, Zirconia reinforced lithium silicate, Lithium disilicate, CAD/CAM