Gingival Health After Zirconia Versus Stainless Steel Crowns in Children

NCT07436325 | Not Yet Recruiting

• 1 other identifier: 25-48-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Do PZCs lead to better gingival health than SSCs over time?
2. 2.Do PZCs reduce plaque accumulation compared to SSCs?
3. 3.Do parents report higher satisfaction with PZCs versus SSCs?
4. 4.Receive PZCs on one primary molar and SSCs on the contralateral molar after tooth preparation
5. 5.Attend follow-up visits at 12, 24, and 36 months for gingival health and plaque assessments
6. 6.Complete parental satisfaction surveys at each follow-up visit

Conditions

Gingival Disease

Keywords

gingival health; Plaque index; Zirconia crown; Stainless steel crown

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12 months, 24 months, and 36 months

Secondary Outcomes (1)

• Plaque Index Score

  Baseline, 12 months, 24 months, and 36 months

Study Arms (2)

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.

Procedure: Prefabricated Zirconia Crown

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

Procedure: Stainless steel crown

Interventions

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™).

Experimental arm (Prefabricated zirconia crowns)

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™)

Active comparator arm (Stainless steel crowns)

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murad Alrashidi: lead

Study Sites (1)

Qassim University

Buraidah, Al-Qassim Province, Saudi Arabia

Location

Related Publications (6)

• 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.

  PMID: 5237684 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.

  PMID: 3013947 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.

  PMID: 41121559 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.

  PMID: 35270531 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.

  PMID: 25102458 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.

  PMID: 30355428 BACKGROUND

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Murad Alrashidi

CONTACT

+966 55 302 2773; MU.ALRASHIDI@qu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Orthodontic and Peadiatric dentistry, College of Dentistry, Qassim University, Saudi Arabia

Model Details: Split Mouth Design

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

SA (1)