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NCT Number: NCT06934460

Direct Versus Indirect Endocrowns on Endodontically Treated Molars

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Composite resin

Device

Direct composite resin restoration after application of an adhesive system

lithium disilicate endocrown

Device

Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing

Primary outcomes

  1. Restoration survival

    Time frame: 5 years

    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.

Secondary outcomes

  1. Abutment tooth survival

    Time frame: 5 years

    Failure defined as tooth extraction, regardless of cause.

Other outcomes

  1. Abutment tooth success

    Time frame: 5 years

    failure was defined as tooth extraction, the presence of endodontic pathology, or the necessity for (non-)surgical endodontic retreatment

  2. Patient satisfaction

    Time frame: 1 and 5 years

    Patient satisfaction measured on VAS-scale (0-100)

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

A Randomised Clinical Study on Indirect Lithium Disilicate Versus Direct Composite Restorations in Severely Compromised Endodontically Treated Molar Teeth

Acronym: Endocrowns

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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