Direct Versus Indirect Endocrowns on Endodontically Treat... | NCT06934460

Studies
Direct Versus Indirect Endocrowns on Endodontically Treated Molars

NCT06934460

Sponsor

University Medical Center Groningen

Status

Active, not recruiting

Last Update Posted

Apr 18, 2025Actual

Enrollment

102Actual

Phase

Not Applicable

Conditions

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

Interventions

Composite resin
lithium disilicate endocrown

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2015Actual

Primary Completion Date

Feb 2028Estimated

Completion Date

Nov 2028Estimated

First Submitted Date

Apr 11, 2025

First Submission Date that Met QC Criteria

Apr 11, 2025

First Posted Date

Apr 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2025

Last Update Posted Date

Apr 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Composite resin	Device	Direct composite resin restoration after application of an adhesive system	Direct composite resin endocrown

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Abutment tooth survival	Failure defined as tooth extraction, regardless of cause.	5 years

Other Outcomes

Measure	Description	Time Frame
Abutment tooth success	failure was defined as tooth extraction, the presence of endodontic pathology, or the necessity for (non-)surgical endodontic retreatment	5 years
Patient satisfaction	Patient satisfaction measured on VAS-scale (0-100)

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco S. Cune, Prof.dr.	Department of Restorative Dentistry and Biomaterials - Center for Dentistry and Oral Hygiene - University Medical Center Groningen	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Start before 2019 with the inclusion and was not mentioned in informed consent forms specifically

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019553	Tooth, Nonvital

Ancestor Terms

ID	Term
D003788	Dental Pulp Diseases
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided