An interventional study of Composite resin and lithium disilicate endocrown in Endodontically-Treated Teeth, Endocrown Restoration and Restoration of Posterior Teeth, sponsored by University Medical Center Groningen. Active, not recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment
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.
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.
113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.
This study's enrollment of 102 is above the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.
Browse Tooth, Nonvital studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ASA i or II [de Jong, 1994], This ASA score is already known before participation, due to regular check-ups.
Exclusion Criteria:
ASA III or higher.
Direct restoration with a microhybrid composite resin
Device: Composite resin
Indirect restoration with a lithium disilicate endocrown in conjunction with Immediate Dentin Sealing
Device: lithium disilicate endocrown
Direct composite resin restoration after application of an adhesive system
Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing
Restoration survival
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.
Time frame: 5 years
Abutment tooth survival
Failure defined as tooth extraction, regardless of cause.
Time frame: 5 years
Abutment tooth success
failure was defined as tooth extraction, the presence of endodontic pathology, or the necessity for (non-)surgical endodontic retreatment
Time frame: 5 years
Patient satisfaction
Patient satisfaction measured on VAS-scale (0-100)
Time frame: 1 and 5 years
No study locations are listed for this record.
Plan to share: Undecided — Start before 2019 with the inclusion and was not mentioned in informed consent forms specifically
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen