Clinical trial NCT02861729: Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns
Official title: Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Coverage Restoration
Keywords: Partial coverage restoration
Crown
Posterior teeth
All ceramic
Zirconia reinforced lithium silicate
Lithium disilicate
CAD/CAM
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth design
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: 12 month
Secondary outcomes:
measure: Restorations with Marginal gap as assessed visually by US public health service criteria
timeFrame: 12 month
measure: Restorations with Marginal discoloration as assessed visually by US public health service criteria
timeFrame: 12 month
measure: Restorations with color mismatch with adjacent teeth as assessed visually by US public health service criteria
timeFrame: 12 month
measure: Restorations with surface roughness as assessed tactilely by US public health service criteria
timeFrame: 12 month
measure: Restorations developed secondary caries as assessed visually by US public health service criteria
timeFrame: 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine- Cairo University
Study officials:
affiliation: Cairo University
name: Hesham Katamish, PHD
role: STUDY_CHAIR
References:
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