A Randomised Clinical Study on Indirect Lithium Disilicate Versus Direct Composite Restorations in Severely Compromised Endodontically Treated Molar Teeth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 102
- Primary Endpoint
- Restoration survival
Study Overview
Brief Summary
In this clinical trial the performance of monolithic restorations made of indirect lithium disilicate ceramic and direct resin composite materials on severe structurally compromised endodontically treated molar teeth is evaluated.
Rationale: It is presumed that indirect restoration of extensively restored endodontically treated molar teeth contributes to durability. However, there is a lack of evidence concerning the performance of both indirect ceramic and direct composite monolithic restorations. Such restorations are commonly named 'endocrowns'.
Objective: The objective of the study is to investigate which treatment modality, indirect ceramic or direct composite endocrowns, provide the best restoration of severe structurally compromised endodontically treated molar teeth in terms of clinical performance.
Study design: Randomised 5-year clinical trial with endodontically treated molar teeth restored with either indirect glass ceramic (experimental) or direct resin composite endocrowns (control).
Study population: A total of 102 severe structurally compromised endodontically treated molar teeth that need to be restored, with a maximum of two restorations per patiënt. Patients are healthy volunteers over 18 years.
Intervention: Each patiënt with a restorative indication for endodontically treated first and second molar teeth will be randomly assigned to one of two treatment groups: indirect glass ceramic endocrown or direct composite endocrown.
Detailed Description
In this clinical trial the performance of monolithic restorations made of indirect lithium disilicate ceramic and direct resin composite materials on severe structurally compromised endodontically treated molar teeth is evaluated.
Rationale: It is presumed that indirect restoration of extensively restored endodontically treated molar teeth contributes to durability. However, there is a lack of evidence concerning the performance of both indirect ceramic and direct composite monolithic restorations. Such restorations are commonly named 'endocrowns'.
Objective: The objective of the study is to investigate which treatment modality, indirect ceramic or direct composite endocrowns, provide the best restoration of severe structurally compromised endodontically treated molar teeth in terms of clinical performance.
Study design: Randomised 5-year clinical trial with endodontically treated molar teeth restored with either indirect glass ceramic (experimental) or direct resin composite endocrowns (control).
Study population: A total of 102 severe structurally compromised endodontically treated molar teeth that need to be restored, with a maximum of two restorations per patiënt. Patients are healthy volunteers over 18 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Statistician
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ASA i or II [de Jong, 1994], This ASA score is already known before participation, due to regular check-ups.
- •Asymptomatic endodontically treated and heavily restored upper and lower molar teeth with an indication for a (new) restoration.
- •Pulp chamber height of at least 2 millimeters.
- •Need of cuspal coverage;
- •Pockets around the molar 3-5 mm.
- •Moderate to low caries risk.
Exclusion Criteria
- •ASA III or higher.
- •Pockets around the molar >5mm.
- •Presence of an accessible furcation.
- •No biological width present (3mm).
- •Rubber dam placement not possible.
- •No antagonistic tooth.
- •History of severe parafunction.
- •High caries risk.
Arms & Interventions
Direct composite resin endocrown
Direct restoration with a microhybrid composite resin
Intervention: Composite resin (Device)
Lithium disilicate endocrown
Indirect restoration with a lithium disilicate endocrown in conjunction with Immediate Dentin Sealing
Intervention: lithium disilicate endocrown (Device)
Outcomes
Primary Outcomes
Restoration survival
Time Frame: 5 years
Failure is defined as restoration replacement or tooth extraction due to secondary decay or vertical root fracture (FDI scre 5). A FDI score of 4 or less indicates survival.
Secondary Outcomes
- Abutment tooth survival(5 years)