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

NCT07091331 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-29

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Universidad Autonoma de Baja California

    lead OTHER

Principal Investigators

  • Alan Velazquez, DDS, MPH · Universidad Autonoma de Baja California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2025-12-30
Completion
2026-06-15
FDA Device
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091331 on ClinicalTrials.gov