Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

Evaluation of Clinical Efficacy of Preformed Pediatric Zirconia Crown and Preformed Pediatric Metal Crown: A Randomized Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carious Teeth
• Intervention / Treatment: Procedure: Prefabricated pediatric zirconia crown group; Procedure: Prefabricated stainless steel crown group

Detailed Description

In this study, zirconia crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betül Şen Yavuz, DDS; Phone Number: +905399887646; Email: dtbetulsen@gmail.com
• Study Contact Backup: Name: Ecem Akbeyaz Şivet, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prefabricated pediatric zirconia crown group; Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA).	Procedure: Prefabricated pediatric zirconia crown group; 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).
Active Comparator: Prefabricated stainless steel crown group; Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)	Procedure: Prefabricated stainless steel crown group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental satisfaction	To assess parental satisfaction regarding the applied restorations, scoring of crowns' appearance, color, shape, size, and general appearance will be requested using a Likert-type scale (Suguna & Gurunathan, 2021). Score 5 indicates the highest level of satisfaction, while score 1 represents the lowest level of satisfaction.; Not at all satisfied; Not satisfied; Neither satisfied nor dissatisfied (Neutral); Satisfied; Very satisfied	24 month

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 20, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 17.05.23marmara

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No