Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Comparison of Self-Adhesive Resin, Conventional Glass Ionomer, and Bioactive Resin-Modified Glass Ionomer Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth: A Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
The goal of this clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. The trial will determine whether any single cement offers superior retention, gum health, or marginal sealing compared to the others over a 3-year period. Main Questions: The study aims to answer the following: Are conventional glass ionomer cement (GIC), bioactive resin-modified glass ionomer cement (BioCem™), and self-adhesive resin cement (SARC) equivalent in retaining prefabricated zirconia crowns on primary incisors over 36 months? Do these cements differ in their effect on gingival health, plaque accumulation, or marginal discoloration around the cemented crown? Comparison: Researchers will compare three parallel groups of children whose primary incisors are restored with identical prefabricated zirconia crowns but cemented with one of the three different luting cements. Participants will: Receive a clinical and radiographic dental examination at screening. Undergo placement of one or more prefabricated zirconia crowns on primary anterior teeth using their randomly assigned cement. Return to the clinic for blinded follow-up evaluations at 12, 24, and 36 months for assessment of crown retention, gingival health, plaque, and marginal staining.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
May 28, 2026
May 1, 2026
3.1 years
May 21, 2026
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Crown Retention (Survival)
The primary outcome is the cumulative retention of prefabricated zirconia crowns over a 36-month follow-up period. Retention is assessed by a single blinded examiner at each scheduled visit using two complementary methods: (a) visual/tactile inspection with a sharp dental explorer applied circumferentially along the crown margin to detect dislodgement, mobility, or marginal gap; and (b) LED transillumination using the DEXIS CariVu® system to detect cracks, debonding, or marginal microleakage. A crown is classified as "failed" (debonded) if any complete loss of cement seal, dislodgement, or detectable marginal gap is observed. Retention is reported as the proportion of crowns surviving at each time point and as the time-to-failure for survival analysis. Higher retention proportions and longer survival times indicate better clinical performance.
Baseline, 12, 24, and 36 months post-cementation
Secondary Outcomes (3)
Plaque Accumulation Measured by the Silness & Löe Plaque Index (1964)
Baseline, 12, 24, and 36 months post-cementation
Gingival Health Measured by the Löe Gingival Index (1967)
Baseline, 12, 24, and 36 months post-cementation
Marginal Discoloration Measured by the Modified United States Public Health Service (USPHS) Criteria
Baseline (immediately post-cementation), 12, 24, and 36 months
Other Outcomes (1)
Incidence and Severity of Adverse Events
Continuously, from cementation through 36 months
Study Arms (3)
Glass Ionomer Cement (GIC) Group
ACTIVE COMPARATORGlass Ionomer Cement (GIC) Group: Participants receive a NuSmile® prefabricated zirconia crown cemented with conventional glass ionomer cement (Fuji IX GP Extra, GC America) following a standardized polyacrylic-acid-conditioning protocol.
Bioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group
EXPERIMENTALBioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with BioCem™ Universal BioActive Cement (NuSmile®, Houston, TX, USA).
Self-Adhesive Resin Cement (SARC) Group
EXPERIMENTALSelf-Adhesive Resin Cement (SARC) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with RelyX™ Universal Resin Cement (3M).
Interventions
Cementation with Fuji IX GP Extra Glass Ionomer Cement Hand-mixed conventional glass ionomer luting cement applied per manufacturer protocol; crown seated under finger pressure for 3 minutes; excess removed after initial set.
Cementation with BioCem™ Universal BioActive Cement Auto-mixed bioactive resin-modified luting cement applied per manufacturer protocol; brief tack-cure to facilitate excess removal followed by full light-curing for 20 seconds per surface.
Cementation with RelyX™ Universal Resin Cement Self-adhesive dual-cure resin luting cement applied per manufacturer protocol; tack-cured for 2-3 seconds for excess removal, followed by full light-curing for 20 seconds per surface.
Eligibility Criteria
You may qualify if:
- Healthy children aged 2 to 7 years
- One or more primary maxillary or mandibular incisors requiring full-coverage restoration due to caries or trauma
- Adequate remaining tooth structure following preparation, defined as greater than 50% of the clinical crown
- Parent or legal guardian able and willing to provide written informed consent and to commit to the 36-month follow-up schedule
You may not qualify if:
- Active periodontal disease at the index tooth, defined as a Löe Gingival Index score of 2 or higher
- Parafunctional habits such as bruxism, severe thumb-sucking, or tongue-thrust documented at screening
- Known allergy or hypersensitivity to zirconia, resin, glass ionomer, or any component of the assigned cement
- Inconsistent oral hygiene, defined as less than twice-daily toothbrushing per parental report
- Systemic disease affecting bone metabolism, tooth development, or wound healing
- Current participation in another interventional dental clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Murad Alrashidilead
Study Sites (1)
Qassim University
Buraidah, Al-Qassim Region, 52571, Saudi Arabia
Related Publications (2)
Leuciuc FV, Petrariu I, Pricop G, Rohozneanu DM, Popovici IM. Toward an Anthropometric Pattern in Elite Male Handball. Int J Environ Res Public Health. 2022 Feb 28;19(5):2839. doi: 10.3390/ijerph19052839.
PMID: 35270532BACKGROUNDWu M, Liu X, Li Z, Huang X, Guo H, Guo X, Yang X, Li B, Xuan K, Jin Y. SHED aggregate exosomes shuttled miR-26a promote angiogenesis in pulp regeneration via TGF-beta/SMAD2/3 signalling. Cell Prolif. 2021 Jul;54(7):e13074. doi: 10.1111/cpr.13074. Epub 2021 Jun 7.
PMID: 34101281BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MURAD ALRASHIDI, BDS, MSC
Qassim University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor performing all post-cementation clinical evaluations is blinded to group allocation. Standardized cheek retractors are used to mask crown margins. The statistical analyst is also blinded to group allocation until after the analysis dataset is locked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor in Orthodontics and Pediatric Dentistry
Study Record Dates
First Submitted
May 21, 2026
First Posted
May 28, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
July 1, 2029
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available beginning 6 months and ending 36 months following article publication.
- Access Criteria
- Data will be shared with researchers who provide a methodologically sound proposal and whose intended use has been approved by an independent review committee. Proposals should be directed to the primary investigator. To gain access, requestors must sign a data access agreement.
The investigators will share de-identified individual participant data underlying the results reported in the final publication. Shared data may include retention status at each time point, time-to-failure, Gingival Index and Plaque Index scores, USPHS marginal discoloration ratings, and adverse event records. The study protocol and statistical analysis plan will also be made available.