An interventional study of Prefabricated Zirconia Crown and Stainless steel crown in Gingival Disease, sponsored by Murad Alrashidi. Active, not recruiting at 1 site in Saudi Arabia. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Murad Alrashidi · Not applicable, Interventional, and Treatment
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:
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:
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.
88 studies on the registry are indexed under Gingival Diseases; 23 are open to participants now.
This study's planned enrollment of 100 is above the median of 46 across 69 interventional studies indexed under Gingival Diseases.
Browse Gingival Diseases studies →Murad Alrashidi is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental arm in this split-mouth randomized clinical trial involves the placement of prefabricated zirconia crowns (PZCs; specifically NuSmile® ZR) on one primary molar per participant.
Procedure: Prefabricated Zirconia Crown
The comparator arm (active control) in this split-mouth randomized clinical trial involves the placement of stainless steel crowns (SSCs; specifically 3M™ ESPE™) on the contralateral primary molar per participant
Procedure: Stainless steel 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™).
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™)
Change in Gingival Health
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) 1. = Mild inflammation - slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation - redness, edema, glazing, bleeding on probing 3. = 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.
Time frame: Baseline, 12 months, 24 months, and 36 months
Plaque Index Score
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 1. = 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 2. = Moderate accumulation of soft deposits within the gingival margin or adjacent tooth surface, visible to the naked eye 3. = 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
Time frame: Baseline, 12 months, 24 months, and 36 months
Plan to share: Yes — Individual participant data will not be shared publicly to protect participant confidentiality. Summary data and results will be published in the peer-reviewed manuscript. Requests for additional aggregate data may be directed to the corresponding author.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Supporting information will be available upon reasonable request starting after publication of the primary results and indefinitely thereafter, or until no longer needed for scientific purposes.
Access criteria: Aggregate/summary data underlying published results and supporting documents such as the study protocol may be shared upon reasonable request to the corresponding author (Murad Alrashdi, email: MU.ALRASHIDI@qu.edu.sa). Requests should include the requester's affiliation, research purpose, and intended use. Access will be granted at the author's discretion for legitimate scientific purpose. No automated repository or public link is planned.
Data sharing details ↗ · orcid.org
Started May 2026 (actual). Primary completion is estimated for May 2029, 36 months after the start.
Of 37 non-industry interventional studies with no phase under Gingival Diseases, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's planned 36 months is above that.
Counting every sponsor, half of 43 studies reached it within 15 months; a quarter within 7 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Murad Alrashidi