3D Printing, Composite Restoration, Posterior Teeth, Semi-direct Restoration
Conditions
Keywords
3D-Printed Composite Resin, Semi-Direct Composite Resin, Digital Dentistry, FDI Criteria, Clinical Evaluation
Brief summary
This randomized controlled clinical trial aims to evaluate the clinical performance of 3D-printed composite resin restorations compared with semi-direct composite resin restorations in posterior teeth requiring Class II inlay or onlay restorations.
Detailed description
Dental restorations are commonly used to restore teeth affected by caries or structural defects. Advances in digital dentistry have introduced three-dimensional (3D) printing technologies that enable the fabrication of indirect composite resin restorations with improved precision, efficiency, and reproducibility. Semi-direct composite resin restorations represent another conservative restorative approach that combines the advantages of direct and indirect techniques while reducing polymerization shrinkage and improving anatomical form. Although both techniques are increasingly used in clinical practice, evidence regarding their long-term clinical performance remains limited. Therefore, this randomized controlled clinical trial aims to compare the clinical performance of 3D-printed composite resin restorations and semi-direct composite resin restorations in posterior teeth requiring Class II inlay or onlay restorations. Sixty patients aged 25 to 40 years who require two Class II inlay or onlay restorations will be enrolled by invitation from patients attending the Faculty of Dentistry, Tanta University. Participants will be randomly allocated into two groups according to the restorative material and fabrication technique used. Group I will receive 3D-printed composite resin restorations, while Group II will receive semi-direct composite resin restorations. All cavity preparations and restorative procedures will be performed according to standardized clinical protocols and manufacturers' instructions. Clinical evaluations will be conducted at baseline, 6 months, 9 months, and 12 months after restoration placement using the modified FDI World Dental Federation criteria. The primary objective is to evaluate the overall clinical performance and survival of the restorations over a 12-month follow-up period. Secondary outcomes include assessment of retention, marginal integrity, surface roughness, anatomical form, postoperative sensitivity, and the occurrence of secondary caries. The findings of this study will contribute to the evidence regarding the effectiveness and clinical reliability of 3D-printed composite resin restorations compared with semi-direct composite resin restorations and may support clinical decision-making in restorative dentistry.
Interventions
OTHER3D-Printed Composite Resin Restorations
Fabrication and placement of Class II inlay or onlay restorations using 3D-printed composite resin material.
OTHERSemi-Direct Composite Resin Restorations
Fabrication and placement of Class II inlay or onlay restorations using the semi-direct composite resin technique
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 25-40 years. * Patients requiring two Class II inlay or onlay restorations. * Teeth with carious lesions or defective restorations requiring indirect restorative treatment. * Teeth with sufficient structure to receive an inlay/onlay restoration.
Exclusion criteria
* Patients with systemic diseases or medical conditions that may affect oral health or healing. * Pregnant or lactating patients. * Patients with poor oral hygiene or uncontrolled periodontal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fracture of restorations | 12 months | Clinical evaluation of restoration fracture or bulk failure after placement of 3D-printed composite resin and semi-direct composite resin restorations. at baseline, 6 months, 9 months, and 12 months after restoration placement. using a modified FDI criteria score. All restorations will be evaluated and categorized based on their clinical performance according to the assigned criteria: score 1 indicates a clinically excellent restoration, scores 2 and 3 represent clinically acceptable restorations, while scores 4 and 5 are considered clinically unacceptable. Clinical success will be defined as restorations receiving scores of 1, 2, or 3, whereas scores of 4 or 5 will be considered clinical failures. |
Countries
Egypt
Outcome results
None listed