Direct Versus Indirect Endocrowns on Endodontically Treated Molars

NCT06934460 | Active Not Recruiting DMC

• 1 other identifier: 201500425
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

endocrown; endocrown restoration; composite resin; direct composite; endodontically-treated teeth

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (1)

• Abutment tooth survival

  5 years

Other Outcomes (2)

• Abutment tooth success

  5 years

• Patient satisfaction

  1 and 5 years

Study Arms (2)

Direct composite resin endocrown

ACTIVE COMPARATOR

Direct restoration with a microhybrid composite resin

Device: Composite resin

Lithium disilicate endocrown

EXPERIMENTAL

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

Device: lithium disilicate endocrown

Interventions

Composite resin DEVICE

Direct composite resin restoration after application of an adhesive system

Direct composite resin endocrown

lithium disilicate endocrown DEVICE

Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing

Lithium disilicate endocrown

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Marco S. Cune, Prof.dr.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial comparing direct composite resin and lithium disilicate endocrowns on endodontically treated molar teeth.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: October 12, 2015
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 18, 2025

Record last verified: 2025-04