NCT07091331

3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars

Clinical Evaluation of 3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universidad Autonoma de Baja California · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are: * How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars? * What is the level of satisfaction of the patient with both materials? * What is the level of parental satisfaction with both materials? Study methodology: This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.

Detailed description

This randomized clinical trial is designed following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will adopt a prospective, split-mouth approach. The objective is to compare the clinical performance of crowns fabricated with three-dimensional (3D) printed ceromer material against conventional preformed stainless steel crowns in extensively decayed primary posterior teeth. The unit of observation will be gingival inflammation in the area surrounding the restorations, evaluated at specific time points over a 12-month follow-up period (3, 6 and 12 months). Each eligible participant will receive both types of crowns, with assignments made to contralateral quadrants of the mouth to allow for within-subject comparison. This methodology minimizes inter-individual variability and strengthens internal validity. The ceromer crowns will be fabricated via additive manufacturing (3D printing), while the stainless steel crowns will follow the conventional selection and crimping technique. Written informed consent will be obtained from their guardians or parents. An expected total of 50 primary molars of healthy participants will be restored.

Conditions

• Caries, Dental
• Caries; Dentin
• Dental Caries in Children

Interventions

Type	Name	Description
PROCEDURE	Personalized 3D-printed pediatric ceromer crown	After primary molar crown preparation, digital impression using intraoral scanner (i700, Medit, Seoul, South Korea), crown will be designed with CAD software (CliniCAD, medit, South Korea) and fabricated using a 3D printer, (Sonic mini 4k, Phrozen, Taipei, Taiwan). Crown will be cemented by passive seating using a self-adhesive dual cure cement (Beauticem, shofu, San Marcos, CA, USA)
DEVICE	Prefabricated stainless steel crown group	Stainless steel crown application: After preparation of the tooth, the crown will be filled and cemented with type-1 glass ionomer cement (Ketac Cem easymix, 3M ESPE, Minnesota, USA)

Timeline

• Start date: 2025-07-30
• Primary completion: 2025-12-30
• Completion: 2026-06-15
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated device study