Active — Not RecruitingNot Applicable

Direct Versus Indirect Endocrowns on Endodontically Treated Molars

102 participantsStarted 2015-10-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Restoration survival

Timeframe: 5 years

Trial details

NCT IDNCT06934460

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

View on ClinicalTrials.gov More Endodontically-Treated Teeth trials