Tooth, NonvitalENDO-3DNCT07633574
Additive vs Subtractive Manufacturing for Endocrown Fabrication: A 24-Month RCT
A study testing CAD/CAM Milled HC Hard Block Endocrown and 3D-Printed VarseoSmile TriniQ Endocrown in people with Tooth, Nonvital and Dental Restoration, run by Cairo University.
Trial summary
This randomized controlled trial (RCT) compares the 24-month clinical performance of endocrown restorations fabricated by two digital manufacturing pathways: additive manufacturing using 3D-printed ceramic-filled photopolymer resin (VarseoSmile TriniQ, BEGO) versus subtractive computer-aided design/computer-aided… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Tooth, Nonvital, Dental Restoration, Endodontically Treated Teeth
- What is being tested?
- CAD/CAM Milled HC Hard Block Endocrown and 3D-Printed VarseoSmile TriniQ Endocrown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Sep 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-45 years, male or female
- Endodontically treated molar tooth with radiographically confirmed treatment success and no clinical signs of failure
- Sufficient remaining coronal structure for endocrown preparation: minimum three walls, wall thickness 1.5 mm or greater, pulp chamber depth 3 mm or greater, supragingival preparation margins
- Completely erupted tooth with intact periodontal support
- Minimum of 20 occluding teeth
- Satisfactory oral hygiene status
- Capable of providing written informed consent and committed to scheduled follow-up visits
Who cannot join
- Diagnosed parafunctional habit or nocturnal bruxism
- Uncontrolled systemic illness or physical disability precluding safe participation
- Heavy tobacco use
- Current or suspected pregnancy
- Periapical disease or radiographic signs of endodontic failure
- Evidence of pathological tooth wear or occlusal erosion
Show all 9Show fewer
- Moderate-to-severe periodontitis or tooth with hopeless prognosis
- Radiographic or clinical evidence of vertical root fracture
- Impaired decision-making capacity or anticipated non-compliance
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rawda H Abdelaziz, BDS MSc PhD contact
About this study
Official title: Additive Versus Subtractive Manufacturing for Endocrown Fabrication: A Clinical Comparison of 3D-Printed Ceramic-Filled Photopolymer Resin and CAD/CAM Milled Resin Nano-Ceramics Endocrowns in Posterior Teeth - A 24-Month Randomized Controlled Trial
This randomized controlled trial (RCT) compares the 24-month clinical performance of endocrown restorations fabricated by two digital manufacturing pathways: additive manufacturing using 3D-printed ceramic-filled photopolymer resin (VarseoSmile TriniQ, BEGO) versus subtractive computer-aided design/computer-aided manufacturing (CAD/CAM) milling from hybrid nano-ceramic blocks (HC Hard Block, Shofu). Sixty endocrowns will be placed in endodontically treated posterior molars and evaluated using modified United States Public Health Service (USPHS) criteria at 6, 12, and 24 months. The trial is conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Read the detailed description
Post-endodontic rehabilitation of extensively damaged posterior molars using endocrowns represents a minimally invasive alternative to conventional crown-plus-post-and-core approaches. Digital fabrication has advanced both the precision and reproducibility of endocrown manufacture. While computer-aided design/computer-aided manufacturing (CAD/CAM) milled hybrid ceramic endocrowns are well-validated clinically, prospective clinical data comparing 3D-printed definitive restorations to milled counterparts are absent. This trial employs a parallel-group, 1:1 randomized design with triple blinding of participants, outcome assessors, and statistician. All restorations are delivered using Beautilink SA self-adhesive dual-cure resin cement. The primary outcome is fracture resistance at 24 months; secondary outcomes include retention, marginal adaptation, marginal discoloration, surface texture, anatomic form, color match, secondary caries, fabrication time, and patient satisfaction assessed by Visual Analogue Scale (VAS).
- Being tested
- CAD/CAM Milled HC Hard Block Endocrown, 3D-Printed VarseoSmile TriniQ Endocrown
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM Milled HC Hard Block EndocrownDevice
Also called CAD/CAM Milled Endocrown
Endocrown restoration milled from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan) using a five-axis wet-milling CAD/CAM unit. Restoration designed with ExoCAD software, finished and glazed per manufacturer protocol, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).
3D-Printed VarseoSmile TriniQ EndocrownDevice
Also called 3D-Printed Endocrown
Endocrown restoration 3D-printed using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH \& Co. KG, Germany) on a 4K LCD printer at 30-45 degree build angle. Post-cured under nitrogen atmosphere, surface glazed, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM Milled Endocrown | Active comparator | Endocrown restoration fabricated by subtractive CAD/CAM milling from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan), designed using ExoCAD software and milled on a five-axis wet-milling unit. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). Receives: Device: CAD/CAM Milled HC Hard Block Endocrown |
| 3D-Printed Endocrown | Experimental | Endocrown restoration fabricated by additive manufacturing using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH \& Co. KG, Germany), printed on a 4K LCD printer at 30-45 degree build angle, post-cured under nitrogen atmosphere. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). Receives: Device: 3D-Printed VarseoSmile TriniQ Endocrown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration Fracture Resistance
Assessed using modified USPHS criteria: Alpha = absence of fracture; Bravo = minor chip amenable to repair; Charlie = catastrophic fracture, unrestorable
Measured: 24 months
Secondary outcomes (8)
Retention
Modified USPHS: Alpha = in situ; Bravo = partial displacement; Charlie = complete loss
Measured: 6, 12, and 24 months
Marginal Discoloration
Modified USPHS: Alpha = absent; Bravo = superficial; Charlie = penetrating
Measured: 6, 12, and 24 months
Surface Texture
Modified USPHS: Alpha = smooth; Bravo = minor irregularities; Charlie = extensive breakdown
Measured: 6, 12, and 24 months
Anatomic Form
Modified USPHS: Alpha = conforms to natural contour; Bravo = discrepancy present, dentin intact; Charlie = dentin or base exposed
Measured: 6, 12, and 24 months
Color Match
Modified USPHS: Alpha = indistinguishable from adjacent tooth; Bravo = minor deviation, clinically acceptable; Charlie = obvious mismatch; Delta = gross color failure
Measured: 6, 12, and 24 months
Secondary Caries
Modified USPHS: Alpha = absent; Charlie = present
Measured: 6, 12, and 24 months
Fabrication Time
Time in minutes from CAD design completion to restoration readiness for cementation
Measured: Periprocedural
Patient Satisfaction
Visual Analogue Scale 0-100 mm; 0 = entirely dissatisfied, 100 = entirely satisfied
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionSep 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 Tooth, NonvitalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ezz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633574
- Sponsor's protocol ID
- /4/26 3D-Printed vs CAD/CAM
- Acronym
- ENDO-3D
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abou-Steit S, Ibrahim SH, Salem M. Three years clinical evaluation of lithium disilicate and hybrid nano-ceramic CAD/CAM endocrowns (randomized clinical trial). Egyptian Dental Journal 2024;70:551-561.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Versus Subtractive Manufacturing for Endocrown Fabrication: A Clinical Comparison of 3D-Printed Ceramic-Filled Photopolymer Resin and CAD/CAM Milled Resin Nano-Ceramics Endocrowns in Posterior Teeth - A 24-Month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07633574
- Acronym / sponsor ID
- ENDO-3D / /4/26 3D-Printed vs CAD/CAM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
This randomized controlled trial (RCT) compares the 24-month clinical performance of endocrown restorations fabricated by two digital manufacturing pathways: additive manufacturing using 3D-printed ceramic-filled photopolymer resin (VarseoSmile TriniQ, BEGO) versus subtractive computer-aided design/computer-aided manufacturing (CAD/CAM) milling from hybrid nano-ceramic blocks (HC Hard Block, Shofu). Sixty endocrowns will be placed in endodontically treated posterior molars and evaluated using modified United States Public Health Service (USPHS) criteria at 6, 12, and 24 months. The trial is conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Detailed description
Post-endodontic rehabilitation of extensively damaged posterior molars using endocrowns represents a minimally invasive alternative to conventional crown-plus-post-and-core approaches. Digital fabrication has advanced both the precision and reproducibility of endocrown manufacture. While computer-aided design/computer-aided manufacturing (CAD/CAM) milled hybrid ceramic endocrowns are well-validated clinically, prospective clinical data comparing 3D-printed definitive restorations to milled counterparts are absent. This trial employs a parallel-group, 1:1 randomized design with triple blinding of participants, outcome assessors, and statistician. All restorations are delivered using Beautilink SA self-adhesive dual-cure resin cement. The primary outcome is fracture resistance at 24 months; secondary outcomes include retention, marginal adaptation, marginal discoloration, surface texture, anatomic form, color match, secondary caries, fabrication time, and patient satisfaction assessed by Visual Analogue Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM Milled Endocrown | Active comparator | Device: CAD/CAM Milled HC Hard Block EndocrownEndocrown restoration fabricated by subtractive CAD/CAM milling from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan), designed using ExoCAD software and milled on a five-axis wet-milling unit. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). |
| 3D-Printed Endocrown | Experimental | Device: 3D-Printed VarseoSmile TriniQ EndocrownEndocrown restoration fabricated by additive manufacturing using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH \& Co. KG, Germany), printed on a 4K LCD printer at 30-45 degree build angle, post-cured under nitrogen atmosphere. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 25-45 years, male or female
- Endodontically treated molar tooth with radiographically confirmed treatment success and no clinical signs of failure
- Sufficient remaining coronal structure for endocrown preparation: minimum three walls, wall thickness 1.5 mm or greater, pulp chamber depth 3 mm or greater, supragingival preparation margins
- Completely erupted tooth with intact periodontal support
- Minimum of 20 occluding teeth
Key exclusion criteria (9 listed)
- Diagnosed parafunctional habit or nocturnal bruxism
- Uncontrolled systemic illness or physical disability precluding safe participation
- Heavy tobacco use
- Current or suspected pregnancy
- Periapical disease or radiographic signs of endodontic failure
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 |
|---|---|---|
| CAD/CAM Milled HC Hard Block EndocrownAlso: CAD/CAM Milled EndocrownEndocrown restoration milled from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan) using a five-axis wet-milling CAD/CAM unit. Restoration designed with ExoCAD software, finished and glazed per manufacturer protocol, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). | Device | CAD/CAM Milled Endocrown |
| 3D-Printed VarseoSmile TriniQ EndocrownAlso: 3D-Printed EndocrownEndocrown restoration 3D-printed using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH \& Co. KG, Germany) on a 4K LCD printer at 30-45 degree build angle. Post-cured under nitrogen atmosphere, surface glazed, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). | Device | 3D-Printed Endocrown |
Primary outcome
Restoration Fracture Resistance
Time frame: 24 months
Assessed using modified USPHS criteria: Alpha = absence of fracture; Bravo = minor chip amenable to repair; Charlie = catastrophic fracture, unrestorable
8 secondary outcomes
Retention
Time frame: 6, 12, and 24 months
Marginal Discoloration
Time frame: 6, 12, and 24 months
Surface Texture
Time frame: 6, 12, and 24 months
Anatomic Form
Time frame: 6, 12, and 24 months
Color Match
Time frame: 6, 12, and 24 months
Secondary Caries
Time frame: 6, 12, and 24 months
Fabrication Time
Time frame: Periprocedural
Patient Satisfaction
Time frame: 6, 12, and 24 months
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 8 Jun 2026.
- BackgroundAbou-Steit S, Ibrahim SH, Salem M. Three years clinical evaluation of lithium disilicate and hybrid nano-ceramic CAD/CAM endocrowns (randomized clinical trial). Egyptian Dental Journal 2024;70:551-561.
- Individual participant dataSharing planned: No
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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.
Rawda H Abdelaziz, BDS MSc PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM Milled HC Hard Block Endocrown and 3D-Printed VarseoSmile TriniQ Endocrown in people with Tooth, Nonvital and Dental Restoration, run by Cairo University.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Jun 2026. 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?
Contact Dina Ez Mohamed, BDS MSc PhD (01008007157, dina.ezz@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration Fracture Resistance (time frame: 24 months). 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 NCT07633574, 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 8 Jun 2026.