Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

NCT05910905 | Completed

• 1 other identifier: 17.05.23marmara
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The study was planned to evaluate and compare the clinical success of prefabricated stainless steel crowns and zirconia crowns used in the primary molars. The study will be carried out in healthy children aged 6-9 years with caries on more than one surface of the primary molars.

Conditions

Carious Teeth

Outcome Measures

Primary Outcomes (1)

• Comparison of clinical success

  According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure. Successful: * No clinical signs or symptoms of pulp pathology * Tooth has exfoliated (without any minor/major failures) * No deformations in the crown/restoration * No pathology observed in radiographs Minor failure: * Reversible pulpitis (No need for root canal treatment or extraction) * Crown/restoration loss that can be restored * Presence of deformations/fractures/perforations in the crown/restoration * Permanent crown remaining submerged * Presence of new caries at the margins Major failure: * Irreversible pulpitis * Crown/restoration loss that cannot be restored * Inter-radicular radiolucency * Internal root resorption

  24 month

Secondary Outcomes (1)

• Parental satisfaction

  24 month

Study Arms (2)

Prefabricated pediatric zirconia crown group

EXPERIMENTAL

Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA).

Procedure: Prefabricated pediatric zirconia crown group

Prefabricated stainless steel crown group

ACTIVE COMPARATOR

Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)

Procedure: Prefabricated stainless steel crown group

Interventions

Prefabricated pediatric zirconia crown group PROCEDURE

Zirconia crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA).

Prefabricated pediatric zirconia crown group

Prefabricated stainless steel crown group PROCEDURE

Stainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented.

Prefabricated stainless steel crown group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 6-9 years with caries on primary molars
• Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
• Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
• Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
• The molars will be treated with a crown indication.
• Presence of symmetry of the primary molar to be treated in the opposite arch.
• The molar to be treated is in occlusion with the antagonist.
• Presence of caries on at least two surfaces of the molars to be treated.
• Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated
• Patients whose parents and themselves agree to participate in the treatment

You may not qualify if:

• Children whose treatment cannot be continued on the dental chair due to cooperation
• Molars that will soon be exfoliated, 1/2 of the root has been resorbed
• The presence of bruxism
• The presence of erosion or attrition-related wear on the opposing molar
• The patient does not come to the control appointment or does not want to continue to the research
• Have allergy to local anesthetic, nickel or chromium
• Complications during treatment.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 20, 2023
• Study Start: January 23, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 18, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)