Direct Versus Indirect Endocrowns on Endodontically Treated Molars

University Medical Center Groningen (UMCG)

Status: Active, not recruiting

Conditions: Restoration of Posterior Teeth; Composite Resins; Endodontically-Treated Teeth; Endocrown Restoration

Treatments: Device: Composite resin; Device: lithium disilicate endocrown

Study type: Interventional

Funder types: Other

Identifiers

NCT06934460

201500425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Direct composite resin endocrown

Active Comparator group

Description:

Direct restoration with a microhybrid composite resin

Treatment:

Device: Composite resin

Lithium disilicate endocrown

Experimental group

Description:

Indirect restoration with a lithium disilicate endocrown in conjunction with Immediate Dentin Sealing

Treatment:

Device: lithium disilicate endocrown