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

NCT07611734 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-28

No results posted yet for this study

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.

Conditions

  • Dental Caries
  • Tooth Injuries
  • Primary Tooth Restoration

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Murad Alrashidi

    lead OTHER

Principal Investigators

  • MURAD ALRASHIDI, BDS, MSC · Qassim University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-06-30
Completion
2029-07-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07611734 on ClinicalTrials.gov