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NCT Number: NCT06774560

Clinical Evaluation of 3D Printed Versus 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.

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.

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Key information

Conditions

Badly Decayed Molars

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Fracture

    Time frame: One Year

    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

Secondary outcomes

  1. Retention

    Time frame: One Year

    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

  2. Marginal adaptation

    Time frame: One Year

    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

  3. Marginal discoloration

    Time frame: One Year

    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

  4. Secondary caries

    Time frame: One Year

    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

  5. Post-operative hypersensitivity

    Time frame: One Year

    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

  6. Surface texture

    Time frame: One Year

    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

  7. Anatomic form

    Time frame: One Year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Sameh assistant lecturer

CONTACT

[email protected]

00201065228277

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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