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

NCT ID: NCT07091331

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2026-06-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3D-printed ceromer crown

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

Group Type: EXPERIMENTAL

Personalized 3D-printed pediatric ceromer crown

Intervention Type: 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)

Stainless steel crown

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

Group Type: ACTIVE_COMPARATOR

Prefabricated stainless steel crown group

Intervention Type: 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)

Interventions

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)

Intervention Type: PROCEDURE

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Baja California

OTHER

Sponsor Role: lead

Responsible Party

Alan Velazquez

D.D.S., M.P.H.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan Velazquez, DDS, MPH

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonoma de Baja California

Locations

Facultad de Odontología

Tijuana, Estado de Baja California, Mexico

Countries

Mexico

Central Contacts

Alan Velazquez, DDS, MPH

Role: CONTACT

avelazquez81@uabc.edu.mx

+526644622237

Sibelli Olivieri, DDS, PhD

Role: CONTACT

sibelli.olivieri@uabc.edu.mx

+5543999750266

Facility Contacts

Patricia Preciado, DDS, MPH

Role: primary

Other Identifiers

2735

Identifier Type: -

Identifier Source: org_study_id