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Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Sponsor: Murad Alrashidi
Summary
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.
Official title: Comparison of Self-Adhesive Resin, Conventional Glass Ionomer, and Bioactive Resin-Modified Glass Ionomer Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
2 Years - 7 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-05
Completion Date
2029-07
Last Updated
2026-05-28
Healthy Volunteers
Yes
Interventions
Cementation with Fuji IX GP Extra Glass Ionomer Cement
Cementation with Fuji IX GP Extra Glass Ionomer Cement Hand-mixed conventional glass ionomer luting cement applied per manufacturer protocol; crown seated under finger pressure for 3 minutes; excess removed after initial set.
Cementation with BioCem™ Universal BioActive Cement
Cementation with BioCem™ Universal BioActive Cement Auto-mixed bioactive resin-modified luting cement applied per manufacturer protocol; brief tack-cure to facilitate excess removal followed by full light-curing for 20 seconds per surface.
Cementation with RelyX™ Universal Resin Cement
Cementation with RelyX™ Universal Resin Cement Self-adhesive dual-cure resin luting cement applied per manufacturer protocol; tack-cured for 2-3 seconds for excess removal, followed by full light-curing for 20 seconds per surface.
Locations (1)
Qassim University
Buraidah, Al-Qassim Region, Saudi Arabia