Composite Resins, Permanent Anterior Teeth, Tooth Fractures (Class IV)
Conditions
Keywords
Class IV Restoration, Layering Techniques, 3D Printed Cast, Shade Matching, Patient Satisfaction
Brief summary
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.
Detailed description
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.
Interventions
DEVICEResin 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.
Sponsors
Al-Azhar University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shade Matching | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Clinical Performance | 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. |
| Patient Satisfaction | 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. |
Countries
Egypt
Outcome results
None listed