Gingival Health After Zirconia Versus Stainless Steel Crowns in Children

StatusActive, Not Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial status changed: Enrolling by Invitation → Active, Not Recruiting Show 5 more changesShow less
    • Primary completion date: May 12, 2029 to May 2029
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description revised
    • Publications: details revised at 3 of 6 entries
    • Eligibility criteria expanded, about 1 word
  2. Notable Trial status changed: Not Yet Recruiting → Enrolling by Invitation
    • Site contact updated
    v4
  3. Notable Start date: Mar 2026 to May 12, 2026
    • Primary completion pushed from Mar 2029 to May 12, 2029
    • Study completion pushed from Apr 2029 to Jun 1, 2029
    v3
  4. Notable Primary endpoint revised
    • Secondary endpoint revised
    • Publications: 4 to 6
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if prefabricated zirconia crowns (PZCs) improve gingival health compared to stainless steel crowns (SSCs) in primary molars of young children. It will also learn about plaque accumulation and parental satisfaction with the crowns. The main questions it aims to answer are: 1. Do PZCs lead to better gingival health than SSCs over time? 2. Do PZCs reduce plaque accumulation compared to SSCs? 3. Do parents report higher satisfaction with PZCs versus SSCs? Researchers will compare PZCs to SSCs in a split-mouth design (each child receives one of each crown type on contralateral molars) to see if PZCs provide superior gingival health, plaque control, and satisfaction. Participants will: 1. Receive PZCs on one primary molar and SSCs on the contralateral molar after tooth preparation 2. Attend follow-up visits at 12, 24, and 36 months for gingival health and plaque assessments 3. Complete parental satisfaction surveys at each follow-up visit
Trial Details
NCT Number NCT07436325
Lead Sponsor Murad Alrashidi
Conditions
(from sponsor)
Gingival Disease
Related terms Gingival Diseases
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov