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Clinical Trials in Mexico / NCT07091331
Starting soon Not applicable

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

NCT07091331 · tracked via the Priya Life Science Mexico tracker
Sponsor
Universidad Autonoma de Baja California
Phase
Not applicable
Started
2025-07-30
Last updated
2025-07-29

Condition(s) studied

Caries, DentalCaries; DentinDental Caries in Children

Investigational drug(s) / intervention(s)

Personalized 3D-printed pediatric ceromer crownPrefabricated stainless steel crown group

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)

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)

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
9 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Plaque index (PI) (Silness and Loe, 1964) — 12 months
    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.
  • Gingival Index (GI) (Loe & Silness, 1963) — 12 months
    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.
  • International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations — 12 months
    Functional, Biological and Esthetic properties, scored from 1-5 (higher score meaning worse result.

Trial sites (1)

FacilityCityRegionStatus
Facultad de Odontología Tijuana Estado de Baja California

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07091331 on ClinicalTrials.gov ↗ ← All trials in Mexico