Clinical trial NCT06934460: Direct Versus Indirect Endocrowns on Endodontically Treated Molars
Official title: A Randomised Clinical Study on Indirect Lithium Disilicate Versus Direct Composite Restorations in Severely Compromised Endodontically Treated Molar Teeth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endodontically-Treated Teeth
Endocrown Restoration
Restoration of Posterior Teeth
Composite Resins
Keywords: endocrown
endocrown restoration
composite resin
direct composite
endodontically-treated teeth
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial comparing direct composite resin and lithium disilicate endocrowns on endodontically treated molar teeth.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Restoration survival
timeFrame: 5 years
Secondary outcomes:
measure: Abutment tooth survival
timeFrame: 5 years
Other outcomes:
measure: Abutment tooth success
timeFrame: 5 years
measure: Patient satisfaction
timeFrame: 1 and 5 years
Locations:
Study officials:
affiliation: Department of Restorative Dentistry and Biomaterials - Center for Dentistry and Oral Hygiene - University Medical Center Groningen
name: Marco S. Cune, Prof.dr.
role: STUDY_DIRECTOR
References: