Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays

Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays Over a Period of One Year: a Randomized Clinical Trial

The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing.

Computer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.

Although additive manufacturing has been known since the 1980s, its application in dentistry is relatively new and not fully studied with limited research and in vivo studies on their clinical performance.

Study Overview

• Status: Not yet recruiting
• Conditions: Badly Decayed Molars
• Intervention / Treatment: Other: CAD/Cam milled onlays; Other: 3D printed onlays

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada Sameh assistant lecturer; Phone Number: 00201065228277; Email: nada.farouk@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age: 25-45 years.

• Males or females.
• Participants with carious vital ower 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CAD/CAM milled onlays; CAD/CAM has had a lasting impact on the dental market for decades. Its clinical reliability compared to any other dental material has been well documented. Several clinical studies proved its high clinical performance and survival rate. As CAD/CAM systems have become established in producing indirect restorations, it is considered the gold standard of digital manufacturing technology in dentistry.	Other: CAD/Cam milled onlays; The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing. Computer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.
Experimental: 3D printed onlays; 3D-printed restorations have shown several advantages. Some studies have shown that the edge and internal gap values of 3D printing restorations are significantly lower than those of milling restorations.	Other: 3D printed onlays; 3D printing technologies are developing more intensively in dentistry as this technology has the capacity to produce shapes or models with high accuracy and in a short time. This method of fabrication takes less time and money and saves on materials compared to CAD/CAM. Although it seems that digital manufacturing technology has made great changes in the restorative dentistry field, this technology is still not fully in use. This is possibly because of the lack of studies and research on this technology, particularly in terms of clinical performance and patient-centred outcomes. 3D printing technologies are novel technologies with a lack of research; therefore, the processing of 3D printing materials is still controversial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year
Marginal adaptation	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year
Marginal discoloration	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year
Secondary caries	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year
Post-operative hypersensitivity	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year
Surface texture	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year
Anatomic form	This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted	One Year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3DP_CAD/CAMM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No