Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruiting Show 6 more changesShow less
    • Start date changed from estimate of May 2026 to May 12, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Site contact updated
    • Publications: details revised at 2 of 2 entries
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. The trial will determine whether any single cement offers superior retention, gum health, or marginal sealing compared to the others over a 3-year period. Main Questions: The study aims to answer the following: Are conventional glass ionomer cement (GIC), bioactive resin-modified glass ionomer cement (BioCem™), and self-adhesive resin cement (SARC) equivalent in retaining prefabricated zirconia crowns on primary incisors over 36 months? Do these cements differ in their effect on gingival health, plaque accumulation, or marginal discoloration around the cemented crown? Comparison: Researchers will compare three parallel groups of children whose primary incisors are restored with identical prefabricated zirconia crowns but cemented with one of the three different luting cements. Participants will: Receive a clinical and radiographic dental examination at screening. Undergo placement of one or more prefabricated zirconia crowns on primary anterior teeth using their randomly assigned cement. Return to the clinic for blinded follow-up evaluations at 12, 24, and 36 months for assessment of crown retention, gingival health, plaque, and marginal staining.
Trial Details
NCT Number NCT07611734
Lead Sponsor Murad Alrashidi
Conditions
(from sponsor)
Dental Caries, Tooth Injuries, Primary Tooth Restoration
Related terms Dental Caries, Tooth Injuries
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov