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NOT YET RECRUITING
NCT07436325
NA

Gingival Health After Zirconia Versus Stainless Steel Crowns in Children

Sponsor: Murad Alrashidi

View on ClinicalTrials.gov

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

Official title: Comparison of Gingival Health Outcomes Between Prefabricated Zirconia Crowns and Stainless Steel Crowns in Primary Molars: A Randomized Split-Mouth Clinical Trial

Key Details

Gender

All

Age Range

3 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03

Completion Date

2029-04

Last Updated

2026-03-02

Healthy Volunteers

Yes

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™)

Locations (1)

Qassim University

Buraidah, Al-Qassim Province, Saudi Arabia