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Enrolling by Invitation

NCT Number: NCT07436325

Gingival Health After Zirconia Versus Stainless Steel Crowns in Children

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

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qassim University

Buraidah, Al-Qassim Province, Saudi Arabia

About this study

This clinical trial is a prospective, randomized, split-mouth controlled study designed to compare the long-term effects of prefabricated zirconia crowns (PZCs) and stainless steel crowns (SSCs) on gingival health, plaque accumulation, and parental satisfaction in primary molars of young children. The study addresses the need for evidence on how these restorative materials influence periodontal outcomes, given the conflicting data in existing literature regarding their biocompatibility, esthetics, and impact on gingival tissues. SSCs have been the standard for durability and cost-effectiveness in pediatric dentistry, but their metallic appearance and potential for plaque retention due to marginal microgaps raise concerns for esthetics and gingival inflammation. PZCs, offering superior esthetics and a polished surface, may provide advantages in reducing plaque adherence and improving mucosal compatibility, though long-term comparative data are limited.

This trial will employ a split-mouth design at the Pediatric Dental Clinic of Qassim University, Buraydah, Al-Qassim Province, Saudi Arabia. This intra-subject approach minimizes inter-individual variability in factors such as salivary composition, microbial ecology, brushing habits, dietary sugar intake, and systemic health, enabling direct comparison of the two crown types within the same child. One hundred healthy children with bilateral primary molars requiring full-coverage restorations will be enrolled. Randomization using a computer-generated sequence with allocation concealment via opaque envelopes opened chairside post-preparation will be implemented. Contralateral molars will receive either a PZC or SSC (randomly assigned), ensuring balanced distribution.

Tooth preparation will be standardized under local anesthesia (2% lidocaine with 1:100,000 epinephrine): pulpotomy/pulpectomy as indicated, circumferential reduction (1-1.5 mm) with tapered diamond burs, occlusal clearance (1.5-2 mm), and proximal adjustments. PZCs will be fitted without crimping for optimal marginal adaptation (<50 μm target), while SSCs will undergo mechanical crimping for tight cervical fit (<30 μm discrepancy). Both will be luted with resin-modified glass ionomer cement (RelyX™ Luting Plus, 3M™) for fluoride release and reliable bonding. Assessments will be conducted by two independent, calibrated examiners (inter-rater kappa >0.80) blinded to crown type via opaque cheek retractors.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children aged 3-7 years.
  • Bilateral primary molars requiring full-coverage restorations.
  • Adequate tooth structure (>50% remaining post-preparation).

Exclusion criteria

  • Children with moderate to severe baseline plaque accumulation (Silness & Löe Plaque Index ≥2) or parents/caregivers reporting inconsistent brushing (<2x/day).
  • Children with excessive sugar intake (>3 sugary snacks/beverages daily), assessed via the Beverage and Snack Questionnaire.
  • Systemic diseases affecting oral health (e.g., immunocompromised status, diabetes mellitus).
  • Active periodontal disease or severe malocclusion.
  • Allergy to crown materials.

Treatment and study plan

Prefabricated Zirconia Crown

Procedure

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™).

Stainless steel crown

Procedure

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™)

Primary outcomes

  1. Change in Gingival Health

    Time frame: Baseline, 12 months, 24 months, and 36 months

    Gingival health assessed using the Löe Gingival Index. Four sites per tooth (mesial, distal, buccal, lingual) are scored as follows:

    0 = Normal gingiva (no inflammation)

    • = Mild inflammation - slight change in color, slight edema, no bleeding on probing
    • = Moderate inflammation - redness, edema, glazing, bleeding on probing
    • = Severe inflammation - marked redness and edema, ulceration, tendency to spontaneous bleeding Mean score per tooth (or per participant across assessed sites) is calculated. Higher scores indicate worse gingival inflammation. This primary outcome evaluates the comparative effect of prefabricated zirconia crowns versus stainless steel crowns on gingival tissue response over time, with assessments performed by blinded calibrated examiners.

Secondary outcomes

  1. Plaque Index Score

    Time frame: Baseline, 12 months, 24 months, and 36 months

    Plaque accumulation assessed using the Silness & Löe Plaque Index. Four sites per tooth (mesial, distal, buccal, lingual) are scored as follows:

    0 = No plaque in the gingival area

    • = A thin film of plaque adhering to the free gingival margin and adjacent area of the tooth; plaque recognized only by running a probe across the tooth surface
    • = Moderate accumulation of soft deposits within the gingival margin or adjacent tooth surface, visible to the naked eye
    • = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin Mean score per tooth (or per participant across assessed sites) is calculated. Higher scores indicate greater plaque thickness and accumulation. This outcome compares plaque control between prefabricated zirconia crowns and stainless steel crowns, evaluated by blinded calibrated examiners

Sponsors and collaborators

Lead sponsor

Murad Alrashidi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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