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

NCT07813949 | Active Not Recruiting

• 2 other identifiers: P-OP-24-03OPDEN108-1-li
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Fractures (Class IV); Composite Resins; Permanent Anterior Teeth

Keywords

Class IV Restoration; Layering Techniques; 3D Printed Cast; Shade Matching; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (2)

• Overall Clinical Performance

  Baseline, 3 months, 6 months, and 12 months

• Patient Satisfaction

  12 months

Study Arms (3)

Monochromatic Layering Group

ACTIVE COMPARATOR

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

Complex Multichromatic Layering Group

EXPERIMENTAL

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

Single-Shaded Structurally-Colored Layering Group

EXPERIMENTAL

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

Interventions

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.

Complex Multichromatic Layering Group; Monochromatic Layering Group; Single-Shaded Structurally-Colored Layering Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Cairo Governorate, 11754, Egypt

Location

MeSH Terms

Conditions

Tooth Fractures; Patient Satisfaction

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Operative Dentistry, Modern University for Technology and Information (MTI)

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 10, 2026
• Study Start: October 27, 2024
• Primary Completion: October 27, 2025
• Study Completion (Estimated): December 27, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)