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Gingival Health After Zirconia Versus Stainless Steel Crowns in Children

NCT07436325 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-15

No results posted yet for this study

Summary

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

Conditions

  • Gingival Disease

Interventions

PROCEDURE

Prefabricated Zirconia Crown

Prefabricated zirconia crown (NuSmile® ZR) placed on primary molar after standardized preparation (1-1.5 mm circumferential reduction, 1.5-2 mm occlusal clearance); cemented with resin-modified glass ionomer (RelyX™ Luting Plus, 3M™).

PROCEDURE

Stainless steel crown

Stainless steel crown (3M™ ESPE™) placed on contralateral primary molar after identical preparation; crown crimped at margins for adaptation; cemented with resin-modified glass ionomer (RelyX™ Luting Plus, 3M™)

Sponsors & Collaborators

  • Murad Alrashidi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2029-05-12
Completion
2029-06-01

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 NCT07436325 on ClinicalTrials.gov