Endodontically-Treated TeethEndocrownsNCT06934460
Direct Versus Indirect Endocrowns on Endodontically Treated Molars
A study testing Composite resin and lithium disilicate endocrown in people with Endodontically-Treated Teeth and Endocrown Restoration, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontically-Treated Teeth, Endocrown Restoration, Restoration of Posterior Teeth
- What is being tested?
- Composite resin and lithium disilicate endocrown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2015to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Randomised Clinical Study on Indirect Lithium Disilicate Versus Direct Composite Restorations in Severely Compromised Endodontically Treated Molar Teeth
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'.
Read more
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.
Read the 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
- Being tested
- Composite resin, lithium disilicate endocrown
- Keywords
- endocrown, endocrown restoration, composite resin, direct composite, endodontically-treated teeth
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite resinDevice
Direct composite resin restoration after application of an adhesive system
lithium disilicate endocrownDevice
Lithium disilicate endocrown in conjunction with Immediate Dentin Sealing
| Study group | Role | What they receive |
|---|---|---|
| Direct composite resin endocrown | Active comparator | Direct restoration with a microhybrid composite resin Receives: Device: Composite resin |
| Lithium disilicate endocrown | Experimental | Indirect restoration with a lithium disilicate endocrown in conjunction with Immediate Dentin Sealing Receives: Device: lithium disilicate endocrown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
Abutment tooth survival
Failure defined as tooth extraction, regardless of cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start12 Oct 2015
- Primary completionFeb 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontically-Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial comparing direct composite resin and lithium disilicate endocrowns on endodontically treated molar teeth.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco S. Cune, Prof.dr., Study director, Department of Restorative Dentistry and Biomaterials - Center for Dentistry and Oral Hygiene - University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934460
- Sponsor's protocol ID
- 201500425
- Acronym
- Endocrowns
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Start before 2019 with the inclusion and was not mentioned in informed consent forms specifically
Publications
de Kuijper MCFM, van den Breemer CRG, de Waal YCM, Lanjouw L, Ozcan M, Cune MS, Gresnigt MMM. Direct Resin Composite and Lithium Disilicate Endocrowns in Severely Compromised Endodontically Treated Molars: A Two-Year Randomized Controlled Trial. Int Endod J. 2026 Jul 27. doi: 10.1111/iej.70232. Online ahead of print.
PubMed 42504948
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Study on Indirect Lithium Disilicate Versus Direct Composite Restorations in Severely Compromised Endodontically Treated Molar Teeth
- ClinicalTrials.gov ID
- NCT06934460
- Acronym / sponsor ID
- Endocrowns / 201500425
- Conditions
- Endodontically-Treated Teeth, Endocrown Restoration, Restoration of Posterior Teeth, Composite Resins
- Keywords
- endocrown, endocrown restoration, composite resin, direct composite, endodontically-treated teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial comparing direct composite resin and lithium disilicate endocrowns on endodontically treated molar teeth.
| Arm | Type | Receives |
|---|---|---|
| Direct composite resin endocrown | Active comparator | Device: Composite resinDirect restoration with a microhybrid composite resin |
| Lithium disilicate endocrown | Experimental | Device: lithium disilicate endocrownIndirect restoration with a lithium disilicate endocrown in conjunction with Immediate Dentin Sealing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- ASA III or higher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Composite resinDirect composite resin restoration after application of an adhesive system | Device | Direct composite resin endocrown |
| lithium disilicate endocrownLithium disilicate endocrown in conjunction with Immediate Dentin Sealing | Device | Lithium disilicate endocrown |
Primary outcome
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.
1 secondary outcome
Abutment tooth survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Derived from this study: PubMed 42504948de Kuijper MCFM, van den Breemer CRG, de Waal YCM, Lanjouw L, Ozcan M, Cune MS, Gresnigt MMM. Direct Resin Composite and Lithium Disilicate Endocrowns in Severely Compromised Endodontically Treated Molars: A Two-Year Randomized Controlled Trial. Int Endod J. 2026 Jul 27. doi: 10.1111/iej.70232. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Start before 2019 with the inclusion and was not mentioned in informed consent forms specifically
Related trials for Endodontically-Treated Teeth
Active, not recruiting
Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns
Endodontically Treated Teeth, Nonvital Teeth
Recruiting
Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior Teeth
Root Canal Treated Posterior Teeth, Endodontically-Treated Teeth
Not yet recruiting
Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
Active, not recruiting
An In-vivo Survival Rate of Different Onlay Materials Placed Over Endodontically Treated Molar Teeth
Dental Restoration Failures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco S. Cune, Prof.dr. study director
Department of Restorative Dentistry and Biomaterials - Center for Dentistry and Oral Hygiene - University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
A study testing Composite resin and lithium disilicate endocrown in people with Endodontically-Treated Teeth and Endocrown Restoration, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06934460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.