An interventional study of Resin Composite Layering Techniques using 3D Printed Casts in Tooth Fractures (Class IV), Composite Resins and Permanent Anterior Teeth, sponsored by Al-Azhar University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Tooth Fractures; 9 are open to participants now.
This study's planned enrollment of 27 is below the median of 40 across 33 interventional studies indexed under Tooth Fractures.
Browse Tooth Fractures studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Teeth restored with light-cured conventional resin composite using monochromatic layering technique on class IV fractured anterior teeth using a 3D printed cast guide.
Device: Resin Composite Layering Techniques using 3D Printed Casts
Teeth restored with light-cured multi-shaded resin composite using complex multichromatic layering technique on class IV fractured anterior teeth using a 3D printed cast guide.
Device: Resin Composite Layering Techniques using 3D Printed Casts
Teeth restored with light-cured single-shaded structurally-colored resin composite layering technique on class IV fractured anterior teeth using a 3D printed cast guide.
Device: Resin Composite Layering Techniques using 3D Printed Casts
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.
Shade Matching
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.
Time frame: Baseline, 3 months, 6 months, and 12 months
Overall Clinical Performance
Assessment of clinical criteria including marginal adaptation, surface texture, fracture/retention, and anatomical form evaluated according to FDI criteria.
Time frame: Baseline, 3 months, 6 months, and 12 months
Patient Satisfaction
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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Oct 2025, 12 months.
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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