Gingival DiseaseNCT07436325
Gingival Health After Zirconia Versus Stainless Steel Crowns in Children
A study testing Prefabricated Zirconia Crown and Stainless steel crown in people with Gingival Disease, run by Murad Alrashidi at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Disease
- What is being tested?
- Prefabricated Zirconia Crown and Stainless steel crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 May 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 3-7 years.
- Bilateral primary molars requiring full-coverage restorations.
- Adequate tooth structure (>50% remaining post-preparation).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Gingival Health Outcomes Between Prefabricated Zirconia Crowns and Stainless Steel Crowns in Primary Molars: A Randomized Split-Mouth Clinical Trial
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:
- Do PZCs lead to better gingival health than SSCs over time?
- Do PZCs reduce plaque accumulation compared to SSCs?
- Do parents report higher satisfaction with PZCs versus SSCs?
Read more
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:
- Receive PZCs on one primary molar and SSCs on the contralateral molar after tooth preparation
- Attend follow-up visits at 12, 24, and 36 months for gingival health and plaque assessments
- Complete parental satisfaction surveys at each follow-up visit
Read the detailed description
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.
- Conditions
- Gingival Disease
- Being tested
- Prefabricated Zirconia Crown, Stainless steel crown
- Keywords
- gingival health, Plaque index, Zirconia crown, Stainless steel crown
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated Zirconia CrownProcedure or surgery
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 crownProcedure or surgery
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™)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
- = 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.
Measured: Baseline, 12 months, 24 months, and 36 months
Secondary outcomes (1)
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
- = 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
Measured: Baseline, 12 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start12 May 2026
- Primary completionMay 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split Mouth Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murad Alrashidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murad Alrashidi, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436325
- Sponsor's protocol ID
- 25-48-04
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 5237684Fischman 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.
PubMed 3013947Alrashdi 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.
PubMed 41121559Alzanbaqi 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.
PubMed 35270531Walia 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.
PubMed 25102458Taran 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.
PubMed 30355428
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gingival Health Outcomes Between Prefabricated Zirconia Crowns and Stainless Steel Crowns in Primary Molars: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07436325
- Acronym / sponsor ID
- 25-48-04
- Conditions
- Gingival Disease
- Keywords
- gingival health, Plaque index, Zirconia crown, Stainless steel crown
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Murad AlrashidiUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do PZCs lead to better gingival health than SSCs over time?
- Do PZCs reduce plaque accumulation compared to SSCs?
- 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:
- Receive PZCs on one primary molar and SSCs on the contralateral molar after tooth preparation
- Attend follow-up visits at 12, 24, and 36 months for gingival health and plaque assessments
- Complete parental satisfaction surveys at each follow-up visit
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split Mouth Design
| Arm | Type | Receives |
|---|---|---|
| Experimental arm (Prefabricated zirconia crowns) | Experimental | Procedure: Prefabricated Zirconia CrownThe 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 | Procedure: Stainless steel crownThe 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 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children aged 3-7 years.
- Bilateral primary molars requiring full-coverage restorations.
- Adequate tooth structure (>50% remaining post-preparation).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prefabricated Zirconia CrownPrefabricated 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 or surgery | Experimental arm (Prefabricated zirconia crowns) |
| Stainless steel crownStainless 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™) | Procedure or surgery | Active comparator arm (Stainless steel crowns) |
Primary outcome
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) 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.
1 secondary outcome
Plaque Index Score
Time frame: Baseline, 12 months, 24 months, and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 5237684Loe 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.
- Background: PubMed 3013947Fischman 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.
- Background: PubMed 41121559Alrashdi 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.
- Background: PubMed 35270531Alzanbaqi 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.
- Background: PubMed 25102458Walia 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.
- Background: PubMed 30355428Taran 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefabricated Zirconia Crown and Stainless steel crown in people with Gingival Disease, run by Murad Alrashidi at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Health (time frame: Baseline, 12 months, 24 months, and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07436325, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.