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OpenTrials
Active, not recruiting

NCT Number: NCT07813949

Evaluation of Clinical Performance, Shade Matching, and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast

The aim of this randomized clinical trial is to compare different resin composite layering techniques (monochromatic, complex multichromatic, and single-shaded structurally-colored composite) using 3D printed casts for the restoration of Class IV anterior tooth fractures. The study will evaluate shade matching, overall clinical performance, and patient satisfaction over a 12-month follow-up period.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Cairo Governorate, 11754, Egypt

About this study

Restoration of anterior fractured teeth (Class IV) presents an aesthetic and technical challenge in restorative dentistry. While direct composite restorations have traditionally relied on free-hand or conventional putty index techniques, recent advances in digital dentistry allow for 3D digital design software and 3D printed casts to create precise palatal guides and optimize anatomical contours and occlusion.

This prospective clinical trial involves 27 adult patients requiring Class IV restorations. Patients are categorized into three equal intervention groups (n=9 each) based on the application technique and resin composite system used: monochromatic layering, complex multichromatic layering, and single-shaded structurally-colored composite. Primary impressions and digital surface scans will be obtained to design missing tooth structures digitally and fabricate 3D printed models. Restoration shade selection will be conducted using both visual and DSLR digital photography techniques. All clinical restorations will be evaluated at baseline, 3 months, 6 months, and 12 months using FDI criteria for clinical performance and shade matching, alongside self-reported patient satisfaction metrics.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female patients aged 18 years or older.
  • Good oral hygiene and healthy periodontal status.
  • Presence of sound adjacent teeth and opposing dentition.
  • Patients requiring direct Class IV composite restoration in permanent anterior teeth.
  • Cooperative patients willing to comply with the follow-up visits (12 months).

Exclusion criteria

  • Patients with poor oral hygiene or severe systemic diseases.
  • Teeth with pulpitis, periapical lesions, or requiring endodontic treatment.
  • Presence of severe bruxism, heavy parafunctional habits, or malocclusion.
  • Pregnant or lactating females.
  • Heavy smokers or patients with active periodontal disease.

Treatment and study plan

Resin Composite Layering Techniques using 3D Printed Casts

Device

Application of resin composite restorations on anterior Class IV fractures using three different layering protocols (monochromatic, complex multichromatic, and single-shaded structurally colored composite) guided by 3D printed casts.

Primary outcomes

  1. Shade Matching

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Evaluation of color match between the resin composite restoration and adjacent natural tooth structure using visual assessment and DSLR digital photography evaluated by FDI criteria.

Secondary outcomes

  1. Overall Clinical Performance

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Assessment of clinical criteria including marginal adaptation, surface texture, fracture/retention, and anatomical form evaluated according to FDI criteria.

  2. Patient Satisfaction

    Time frame: 12 months

    Evaluation of patient satisfaction regarding aesthetic appearance, shade match, and overall treatment outcome assessed using the Visual Analog Scale (VAS), where scores range from 0 (completely dissatisfied) to 10 (completely satisfied), with higher scores indicating better satisfaction.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of the Clinical Performance, Shade Matching and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 11, 2026

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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