Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Cairo Governorate, 11754, Egypt
NCT Number: NCT07813949
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11754, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
This study is active but is not currently recruiting participants.
Notify MeAl-Azhar University
Other
Evaluation of the Clinical Performance, Shade Matching and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast
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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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