Endodontically-Treated Teeth, Endocrown Restoration, Restoration of Posterior Teeth, Composite Resins
Conditions
Keywords
endocrown, endocrown restoration, composite resin, direct composite, endodontically-treated teeth
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. 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.
Interventions
DEVICEComposite resin
Direct composite resin restoration after application of an adhesive system
DEVICElithium disilicate endocrown
Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistician
Intervention model description
Randomized clinical trial comparing direct composite resin and lithium disilicate endocrowns on endodontically treated molar teeth.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Abutment tooth survival | 5 years | Failure defined as tooth extraction, regardless of cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Abutment tooth success | 5 years | failure was defined as tooth extraction, the presence of endodontic pathology, or the necessity for (non-)surgical endodontic retreatment |
| Patient satisfaction | 1 and 5 years | Patient satisfaction measured on VAS-scale (0-100) |
Outcome results
None listed