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

NCT06774560 | Not Yet Recruiting

• 1 other identifier: 3DP_CAD/CAMM
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Badly Decayed Molars

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Retention

  One Year

• Marginal adaptation

  One Year

• Marginal discoloration

  One Year

• Secondary caries

  One Year

• Post-operative hypersensitivity

  One Year

Study Arms (2)

CAD/CAM milled onlays

ACTIVE COMPARATOR

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

3D printed onlays

EXPERIMENTAL

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

Interventions

CAD/Cam milled onlays OTHER

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.

CAD/CAM milled onlays

3D printed onlays OTHER

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.

3D printed onlays

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Nada Sameh assistant lecturer

CONTACT

00201065228277; nada.farouk@dentistry.cu.edu.eg

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: Principal investigator

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 14, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2025

Record last verified: 2024-12