NCT07853118

Brief Summary

The aim of this study is to clinically evaluate the performance of 3D-printed resin and CAD/CAM lithium disilicate overlay restorations.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress19%
Jul 2026Aug 2027

Study Start

First participant enrolled

July 26, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2027

Expected
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

3D-printedLithium DisilicateOverlay RestorationsCAD/CAM

Keywords

overlay restorationsClinical3D-PrintedCAD/CAM-Milled Lithium DisilicateFDI criteria

Outcome Measures

Primary Outcomes (1)

  • Fracture of restoration

    12 months

Study Arms (2)

3D-Printed Ceramic-Filled Resin Overlay

EXPERIMENTAL

Participants allocated to this group will receive posterior molar overlay restorations fabricated from ODYX-CR ceramic-filled composite resin using a digital light processing (DLP) three-dimensional printing workflow

Other: 3D-printed ODYX-CR ceramic-filled resin

CAD/CAM-Milled Lithium Disilicate Overlay

EXPERIMENTAL

Participants allocated to this group will receive posterior molar overlay restorations fabricated from CAD/CAM-milled lithium disilicate ceramic blocks.

Other: CAD/CAM-milled lithium disilicate ceramic

Interventions

3D-printed ODYX-CR ceramic-filled resinOTHER

The ODYX-CR restorations will be fabricated using digital light processing (DLP) 3D printing; restorations will be adhesively cemented using preheated resin composite following the respective manufacturer's recommended surface-treatment protocols. Clinical performance will be evaluated at baseline (24 hours), 6, 12, months using Fédération Dentaire Internationale (FDI) clinical criteria, including functional, biological, and esthetic properties.

3D-Printed Ceramic-Filled Resin Overlay
CAD/CAM-milled lithium disilicate ceramicOTHER

The comparator restorations will be fabricated by milling lithium disilicate CAD/CAM blocks. Both restorations will be adhesively cemented using preheated resin composite following the respective manufacturer's recommended surface-treatment protocols. Clinical performance will be evaluated at baseline (24 hours), 6, 12, months using Fédération Dentaire Internationale (FDI) clinical criteria, including functional, biological, and esthetic properties.

CAD/CAM-Milled Lithium Disilicate Overlay

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health.
  • Good oral hygiene.
  • Molars requiring overlay restorations with at least one cusp thickness ≤2 mm

You may not qualify if:

  • Bruxism or parafunctional habits.
  • Severe periodontal disease.
  • Pregnancy or lactation.
  • Severe malocclusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Tanta, 31527, Egypt

Location

Related Publications (4)

  • Abdelgawad AHY, Hamed NHM, Soliman ZDE, Kamel MA. Fracture resistance of structurally compromised maxillary premolars restored with different bulk-fill base materials and CAD/CAM milled and 3D printed hybrid composite overlays: an in vitro study. Odontology. 2026 May 13. doi: 10.1007/s10266-026-01404-5. Online ahead of print.

    PMID: 42126495RESULT

  • Sonkaya E, Zeliha Bek Kurklu G. Additively Manufactured Definitive Crown Resins on Premolar and Molar Teeth: 2-Year Results of a Prospective Clinical Study. Int J Prosthodont. 2025 May 21;38(3):279-289. doi: 10.11607/ijp.9200.

    PMID: 39486004RESULT

  • Rachiotis I, Pachiou A, Salem M, Karasan D, Sailer I, Rahiotis C. Three-Dimensional Printed Materials for Definitive Ceramic and Resin Restorations: A Scoping Review. Materials (Basel). 2026 Sep 1;19(17):3728. doi: 10.3390/ma19173728.

    PMID: 42738164RESULT

  • Alghauli MA, Alqutaibi AY. 3D-printed intracoronal restorations, occlusal and laminate veneers: Clinical relevance, properties, and behavior compared to milled restorations; a systematic review and meta-analysis. J Esthet Restor Dent. 2024 Aug;36(8):1153-1170. doi: 10.1111/jerd.13228. Epub 2024 Mar 29.

    PMID: 38551205RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 1, 2026

Study Start

July 26, 2026

Primary Completion (Estimated)

July 29, 2027

Study Completion (Estimated)

August 10, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)