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Completed

NCT Number: NCT05910905

Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Comparison of clinical success

    Time frame: 24 month

    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

Secondary outcomes

  1. Parental satisfaction

    Time frame: 24 month

    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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 20, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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