NCT07378982

Brief Summary

II. Introduction: 6\. Background and rationale: Restoring badly mutilated teeth was and has always been a challenge in restorative dentistry. In order to solve this issue, different approaches have been proposed, including cuspal protection or cuspal coverage. This proved to increase the fracture resistance of remaining tooth structure and overall survivability of endodontically treated teeth. Different materials and techniques have been proposed to attain cuspal coverage, such as using indirect milled or pressed ceramics, indirect milled composite, and direct composite restorations(Abu-Awwad, 2019). The integration of 3D printing in dentistry has revolutionized the fabrication of permanent indirect restorations, including inlays, onlays, and overlays. Evaluation of whether the mechanical properties, clinical feasibility, and accuracy of 3D-printed resin restorations are compared to traditional milled and pressed alternatives. Key findings highlight superior marginal fit, cost-efficiency, and adaptability of 3D-printed resins, while addressing limitations such as stain susceptibility and long-term durability Research question: Does a 3D printed ceramic-filled photopolymer resin show any difference in clinical performance when compared to a CAD/CAM milled composite in restoring badly decayed endodontically treated posterior teeth? Statement of the problem: The problems of indirect milled composites include the initial cost of the milling machine, running cost of machine repairs, bur changes, and the cost of discs and blocks, not to mention that the concept of milling as a manufacturing process has an unavoidable loss of material. (Josic et al., 2023) Rationale for conducting the research: Indirect restorations, such as inlays (without cusp coverage), onlays (partial cusp coverage), and overlays (full cusp coverage), aim to preserve tooth structure while restoring function and esthetics. Historically, these restorations were fabricated using ceramics or composite resins via subtractive milling or heat-pressing techniques. However, 3D printing has emerged as a transformative technology, enabling additive manufacturing of resin-based restorations with enhanced precision and reduced material waste. (Tribst et al., 2024) Review of literature: Extensively destructed endodontically treated molars may represent a high-risk restorative scenario due to loss of internal dentin support and undermined cusps leading to increased flexure, stress concentration and analysis, making failure more likely to occur due to cuspal fracture, bulk fracture, tooth splitting or adhesive debonding rather than simple marginal defects. Contemporary restorative concepts therefore emphasize preserving remaining tooth structure while providing cuspal coverage through adhesively bonded partial-coverage restorations like onlays, overlays and endocrowns, aiming to redistribute occlusal loads and reduce catastrophic tooth fracture. Clinical reviews of root-filled teeth consistently highlight that prognosis depends less on "endodontic status" itself and more on the quantity and quality of remaining coronal tissue, presence of ferrule, and the capacity of the definitive restoration to protect the tooth under function. Among current treatment options, direct resin composite restorations remain attractive for being conservative, repairable, and cost-efficient. However, the effectiveness of this treatment modality decreases as cavity size leading to increased polymerization shrinkage stresses, reduced cuspal stiffness as a result of increased cavity depth, difficulty in achieving durable proximal anatomy in very large defects, and technique sensitivity under moisture compromised isolation, which can translate into higher risk of fracture or marginal breakdown over time. Indirect restorations including full crowns, partial-coverage ceramic restorations, and resin-based CAD/CAM restorations can provide better anatomic control and cuspal coverage, but has some drawbacks like added steps, cost, and may require more tooth reduction depending on design and material used. Systematic review and meta-analysis evidence focusing specifically on endodontically treated posterior teeth suggests that outcomes between direct composite and indirect approaches can be broadly comparable in some settings, but there is a tendency for indirect restorations to be favored as defect severity increases and remaining walls decrease, while direct restorations may be more appropriate for smaller defects; importantly, the available evidence is heterogeneous and often limited by variation in preparation design, materials, and follow-up.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Oct 2027

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 23, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

3D printingCAD/CAM millingOverlay restoration

Outcome Measures

Primary Outcomes (1)

  • Restoration Integrity, Fracture

    Primary outcome will be measured using modified USPHS Criteria with A,B \& C grades A: No evidence of restoration fracture. B: Minor chipping of restoration prone to repair. C: Severe chipping or bulk fracture beyond repair.

    measurements will be taken Immediate Post restorative, 6 month, 12 month & 18 month follow ups

Study Arms (2)

Intervention

EXPERIMENTAL

The Intervention Group will receive 3D-printed overlay restorations for endodontically treated molar teeth.

Procedure: 3D printed overlay restorations

Control Group

ACTIVE COMPARATOR

The Control Group will receive CAD/CAM milled overlay restorations for endodontically treated molar teeth.

Procedure: CAD/CAM restorations

Interventions

Computer-aided design (CAD) will be done by a 3D designing software (ExoCAD), and files will be created in CAD generated model file (STL format file). Then it will be placed in a nesting software (CHITOBOX) to create a Color-dependent Plot Style Table extension file (.ctb). Placement of the restoration in the nesting software will be at 30-45 degrees to increase precision of the printed restoration. (Metin et al., 2024) Then 3D printing of the restoration using a 4K LCD printer (Microdent 1 Pro, Mogassam, Egypt). After Printing of the restoration, the excess resin will air dried then placed in 99 % ethanol ultrasonic bath for 5 minutes followed by air dryness to romove excess uncured resin, follwed by post-curing in a nitrogen enviroment curing box with otoflash mode (LED Curing machine N1, Inox MENA) for 180-240 seconds. (Özden and Altınok Uygun, 2025), (Lim et al., 2024)

Also known as: additive manufacturing
Intervention

Computer designing and machining (milling): Computer-aided design (CAD) will be done using 3D designing software (ExoCAD), an STL format file will be exported to the milling machine. Then restoration from Composite blocks will be wet milled using a 5-axis milling machine. Same steps regarding glazing and polishing will be done same to the intervention group.

Also known as: subtractive manufacturing
Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • For Participants:
  • Age: 18-60 years.
  • Males or females.
  • Participants with endodontically treated molar teeth. Lower molars indicated for onlay (one or two missing cusps)
  • Patients with at least 20 teeth under occlusion.
  • Good oral hygiene.
  • Co-operative patients approving to participate in the trial.
  • Have sufficient cognitive ability to understand consent procedures.
  • For Teeth:
  • Badly destructed endodontically treated molars teeth indicated for cuspal total cuspal coverage (Overlay restoration)
  • No signs or symptoms after endodontic treatment.
  • No signs of clinical mobility.
  • Teeth with healthy periodontium.

You may not qualify if:

  • For Participants:
  • Participants with parafunctional habits or bruxism.
  • Participants with systemic diseases or disabilities that may affect participation.
  • Heavy smoking.
  • Pregnancy.
  • Lack of compliance.
  • Severe or active periodontal disease.
  • Cognitive impairment for teeth:
  • Periapical pathosis indicating failure in endodontic treatment.
  • Vital teeth.
  • Signs of pathological wear.
  • Severe periodontal affection or tooth indicated for extraction.
  • Signs of Vertical root fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 11553, Egypt

Location

Related Publications (4)

  • Nam, N.E., Hwangbo, N.K., Kim, J.E., 2024. Effects of surface glazing on the mechanical and biological properties of 3D printed permanent dental resin materials. J. Prosthodont. Res. 68, 273-282. https://doi.org/10.2186/jpr.JPR_D_22_00261 Özden, Y., Altınok Uygun, L., 2025. Effects of postcuring times on the trueness of 3D -printed dental inlays made with permanent resins. Clin. Oral Investig. 29. https://doi.org/10.1007/s00784-025-06319-z

    BACKGROUND
  • Mudhaffer, S., Haider, J., Satterthwaite, J., Silikas, N., 2025. Effects of print orientation and artificial aging on the flexural strength and flexural modulus of 3D printed restorative resin materials.Manchester,UK.https://doi.org/ns.org/licenses/by/4.0/).https://doi.org/10.1016/j.prosdent.2024.08.008

    BACKGROUND
  • Metin, D.S., Schmidt, F., Beuer, F., Prause, E., Ashurko, I., Sarmadi, B.S., Unkovskiy, A., 2024. Accuracy of the intaglio surface of 3D-printed hybrid resin-ceramic crowns, veneers and table-tops: An in vitro study. J. Dent. 144. https://doi.org/10.1016/j.jdent.2024.104960

    BACKGROUND
  • Lim, B., Kim, D., Song, J.S., Kim, S., Kim, H., Shin, Y., 2024. Influence of Post-Curing in Nitrogen-Saturated Condition on the Degree of Conversion and Color Stability of 3D-Printed Resin Crowns. Dent. J. (Basel). 12. https://doi.org/10.3390/dj12030068

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate in Restorative & Esthetics Dentistry, Cairo University

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

February 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations