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

NCT07091331 | Not Yet Recruiting FDA Device

• 1 other identifier: 2735
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Printing, Three-dimensional; Pediatric Dentistry; Tooth, Deciduous; Esthetics, Dental

Outcome Measures

Primary Outcomes (3)

• Plaque index (PI) (Silness and Loe, 1964)

  0- No plaque in the area adjacent to the gingiva 1. There is a thin film on the edge of the gingival margin. (detected with the help of a probe) 2. There is presence of plaque in the gingival pocket and gingival margin at a level that can be determined by eye. There is no plaque in the proximal area. 3. A large amount of plaque layer is observed in the gingival pocket and gingival margin. Interdental area is filled with plaque.

  12 months

• Gingival Index (GI) (Loe & Silness, 1963)

  0- Healthy gingiva, no inflammation 1. Mild inflammation, discoloration and mild edema of the gums, no bleeding on probing. 2. Moderate inflammation, redness and edema in gums, bleeding on probing. 3. Advanced inflammation, redness, edema in gums, spontaneous bleeding is observed.

  12 months

• International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations

  Functional, Biological and Esthetic properties, scored from 1-5 (higher score meaning worse result.

  12 months

Secondary Outcomes (2)

• Patient satisfaction

  6 months

• Parental satisfaction

  6 months

Study Arms (2)

3D-printed ceromer crown

EXPERIMENTAL

Group A: 3D-printed ceromer crown (Sculpture, Rodin Resins, La Brea, CA, USA)

Procedure: Personalized 3D-printed pediatric ceromer crown

Stainless steel crown

ACTIVE COMPARATOR

Group B: Stainless steel crown (3M Espe, Saint Paul, MN, USA)

Device: Prefabricated stainless steel crown group

Interventions

Personalized 3D-printed pediatric ceromer crown PROCEDURE

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)

3D-printed ceromer crown

Prefabricated stainless steel crown group DEVICE

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)

Stainless steel crown

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 9 years with at least 2 primary molars affected by deep occlusoproximal caries.
• Teeth may require pulp therapy (pulpotomy or pulpectomy) and be suitable for full-coverage restoration.
• Teeth must have an antagonist and be located in opposing hemiarches.
• The affected primary molars must be expected to remain in the mouth for at least 12 months.
• The child must be in general good health.
• Parents or legal guardians must sign informed consent, and the child must provide assent.
• Patient does not come to control appointment or does not want to continue research.

You may not qualify if:

• Children with systemic diseases or medical conditions affecting oral health.
• Uncooperative behavior (Frankl scale 3 or 4).
• Temporomandibular joint disorders or parafunctional habits (e.g., bruxism).
• Absence of antagonist or adjacent teeth in the selected quadrants.
• Children on long-term medication.
• Patient with allergy to local anesthetic, nickel or chromium.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Facultad de Odontología

Tijuana, Estado de Baja California, 22427, Mexico

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Alan Velazquez, DDS, MPH

  Universidad Autonoma de Baja California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Velazquez, DDS, MPH

CONTACT

+526644622237; avelazquez81@uabc.edu.mx

Sibelli Olivieri, DDS, PhD

CONTACT

+5543999750266; sibelli.olivieri@uabc.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the esthetic nature of the different materials, masking of the participants and investigators is not possible, however outcomes assessor with be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: D.D.S., M.P.H.

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: July 30, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)