Clinical Evaluation of Three-Dimensional (3D) Printing Resin Nanoceramic Crown Restoration.

NCT07228572 | Active Not Recruiting

• 1 other identifier: EGE-DHF-OS-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the function and aesthetics of ceramic-filled hybrid resin permanent crowns produced by 3D printing method in posterior teeth according to Revised FDI criteria. At the Department of Prosthodontics, Faculty of Dentistry, Ege University, 60 patients who present for single-tooth crown restoration in the posterior region of either the maxilla or mandible and who meet the inclusion criteria will receive a total of 60 permanent crown restorations. Following tooth preparation, the restorations will be fabricated using a three-dimensional (3D) printing technique with a ceramic-filled hybrid resin material (VarseoSmile TriniQ, Bego, Bremen, Germany). The effects of restorations on clinical success will be evaluated according to demographic data (age, gender, etc.) and modified USPHS and Revised FDI criteria, and statistical analysis will be applied to the recorded data. Follow-up visits are scheduled at 0: baseline, 6, and 12 months.

Conditions

3d Printing Ceramic Restoration; Nanoceramic Crown Restoration for Posterior Teeth

Keywords

nanoceramic crown; 3d printed

Outcome Measures

Primary Outcomes (2)

• Revised FDI criteria for evaluating direct and indirect dental restorations

  In 2007, an international workgroup published new FDI criteria to evaluate the quality of direct and indirect restorations; an update with clinical cases was published in 2010. Then, these criteria are revised in 2022. This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion. In detail, scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).

  one year

• Modified united states public health service (USPHS) criteria

  The clinical performance of crown restorations are evaluated by using USPHS criteria. Parameters such as color match, anatomic form, marginal integrity, surface roughness, retention and post-operative sensitivity are assessed. Each parameter is scored using Alpha, Bravo and Charlie ratings. Alpha indicates to optimal clinical performance, Bravo rating is for an acceptable level and Charlie rating represents the need for restoration repair or replacement.

  one year

Study Arms (1)

nanoceramic crown restorations ; clinical evolution

EXPERIMENTAL

the crown preparation for the tooth of each patient included in the study will be perfomered using preparation bur set under water cooling with a rotary handpiece. then digital impression of the prepared teeth will be obtained using an intra-oral scanner to facilitate the design of crown restorations. following their design and fabrication, the 3d printed nanoceramic crown restorations will be adhesively cemented to the teeth after verifying their fit.

Other: 3D printing hybrid ceramic crown restorations

Interventions

3D printing hybrid ceramic crown restorations OTHER

crown restorations fabricated with 3D printing nanoceramic will be applied to 60 patients. following the 6 and 12 month follow-ups, the collected data will be analyzed according to clinical evaluation criteria.

nanoceramic crown restorations ; clinical evolution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between 18 and 65 years of age, Patients requiring a single crown restoration in the posterior region of the maxilla or mandible, Absence of active periodontal disease, Presence of an opposing tooth (natural or restored), Presence of adjacent teeth (mesial and distal), Vital or endodontically treated (devital) teeth without periapical lesions, Patients who agree to comply with the study conditions will be included in the study.

You may not qualify if:

• Suspected or confirmed pregnancy, or patients in the breastfeeding period, Teeth requiring coverage that are intended to serve as abutments for fixed partial dentures, Vital or endodontically treated (devital) teeth with periapical lesions, Absence of an opposing tooth or presence of an opposing tooth restored with a crown, Absence of adjacent teeth (mesial or distal), Individuals with temporomandibular joint disorders (TMDs), patients who do not consent to the study conditions will be excluded from the study.

Sponsors & Collaborators

• Ege University: lead
• Ege University Scientific Research Projects Coordination: collaborator

Study Sites (1)

Ege University, Faculty of Dentistry, Department of Prosthodontics

Izmir, İzmir, 35040, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: case - control study

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

TU (1)