Direct Versus Indirect Endocrowns on Endodontically Treated Molars

NCT ID: NCT06934460

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-12
• Study Completion Date: 2028-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct composite resin endocrown

Direct restoration with a microhybrid composite resin

Group Type: ACTIVE_COMPARATOR

Composite resin

Intervention Type: DEVICE

Direct composite resin restoration after application of an adhesive system

Lithium disilicate endocrown

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

Group Type: EXPERIMENTAL

lithium disilicate endocrown

Intervention Type: DEVICE

Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing

Interventions

Composite resin

Direct composite resin restoration after application of an adhesive system

Intervention Type: DEVICE

lithium disilicate endocrown

Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco S. Cune, Prof.dr.

Role: STUDY_DIRECTOR

Department of Restorative Dentistry and Biomaterials - Center for Dentistry and Oral Hygiene - University Medical Center Groningen

Other Identifiers

201500425

Identifier Type: -

Identifier Source: org_study_id