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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm (Prefabricated zirconia crowns) | Experimental | 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. |
|
| Active comparator arm (Stainless steel crowns) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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™). |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| Baseline, 12 months, 24 months, and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qassim University | Buraidah | Al-Qassim Province | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5237684 | Background | Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available. | |
| 3013947 | Background | Fischman SL. Current status of indices of plaque. J Clin Periodontol. 1986 May;13(5):371-4, 379-80. doi: 10.1111/j.1600-051x.1986.tb01475.x. |
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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 will be available upon reasonable request starting after publication of the primary results and indefinitely thereafter, or until no longer needed for scientific purposes.
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.
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| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Split Mouth Design
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| 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™) |
|
| Baseline, 12 months, 24 months, and 36 months |
| 41121559 | Background | Alrashdi M, Alkhuwaiter S. Clinical Outcomes for Prefabricated Zirconia Crowns in Primary Dentition: A Systematic Review and Meta-Analysis. Pediatr Dent. 2025 Sep 15;47(5):312-321. |
| 35270531 | Background | Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838. |
| 25102458 | Background | Walia T, Salami AA, Bashiri R, Hamoodi OM, Rashid F. A randomised controlled trial of three aesthetic full-coronal restorations in primary maxillary teeth. Eur J Paediatr Dent. 2014 Jun;15(2):113-8. |
| 30355428 | Background | Taran PK, Kaya MS. A Comparison of Periodontal Health in Primary Molars Restored with Prefabricated Stainless Steel and Zirconia Crowns. Pediatr Dent. 2018 Sep 15;40(5):334-339. |