DETERMINATION OF THE EFFECTS OF STAINLESS STEEL CROWNS CEMENTED WITH RESIN CEMENTS ON INTERLEUKIN-10, 12, 18 LEVELS IN GINGIVAL CREVICULAR FLUID
SSC-CYTO
Determination of the Effects of Stainless Steel Crowns Cemented With Resin Cements on Interleukin-10, Interleukin-12, and Interleukin-18 Levels in Gingival Crevicular Fluid
2 other identifiers
interventional
45
1 country
1
Brief Summary
This split-mouth clinical study aimed to evaluate the early effects of stainless steel crowns cemented with self-adhesive resin cement and high-viscosity glass ionomer cement on clinical periodontal parameters and interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) levels in gingival crevicular fluid in pediatric patients. The study included 45 systemically healthy children aged 6-10 years. Stainless steel crowns were placed on the mandibular second primary molars (teeth 75 and 85) in each patient; tooth 75 was cemented with a self-adhesive resin cement (G-Cem ONE™, GC, Japan), while tooth 85 was cemented using a high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan). Plaque index, gingival index, and bleeding on probing were recorded before treatment and one week after cementation. Gingival crevicular fluid samples were collected at the same time points, and IL-10, IL-12, and IL-18 levels were analyzed using the ELISA method. A statistically significant reduction in plaque index values was observed in both cement groups at the one-week follow-up (p\<0.001), whereas no significant differences were found in gingival index or bleeding on probing values (p\>0.05). IL-10 and IL-12 levels did not change significantly in either group, whereas IL-18 levels decreased significantly in the resin cement group and were significantly higher in the glass ionomer cement group postoperatively. These findings suggest that although different cementation materials used for stainless steel crowns yield similar short-term clinical periodontal outcomes, material-related differences may exist in gingival biological responses, particularly with respect to IL-18 levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Shorter than P25 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
First Submitted
Initial submission to the registry
February 12, 2026
CompletedStudy Start
First participant enrolled
February 16, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
ExpectedFebruary 19, 2026
February 1, 2026
1 month
February 12, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
IL-18
IL-18 levels in gingival crevicular fluid were measured using ELISA before stainless steel crown cementation and one week after cementation to evaluate early biological periodontal response to different cementation materials.
Baseline and 1 week post-cementation
Change in gingival crevicular fluid interleukin-12 (IL-12)levels
IL-12 levels in gingival crevicular fluid were measured using ELISA before stainless steel crown cementation and one week after cementation to evaluate early biological periodontal response to different cementation materials.
Baseline and 1 week post-cementation
Change in gingival crevicular fluid interleukin-10 (IL-10) levels
IL-10 levels in gingival crevicular fluid were measured using ELISA before stainless steel crown cementation and one week after cementation to evaluate early biological periodontal response to different cementation materials.
Baseline and 1 week after cementation
Study Arms (2)
Self-Adhesive Resin Cement Group
EXPERIMENTALIn this split-mouth clinical study, stainless steel crowns placed on mandibular second primary molars (tooth 75) were cemented using a self-adhesive resin cement (G-Cem ONE™, GC, Japan). Clinical periodontal parameters (plaque index, gingival index, and bleeding on probing) and gingival crevicular fluid levels of interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) were evaluated before treatment and one week after cementation.
High-Viscosity Glass Ionomer Cement Group
ACTIVE COMPARATORIn the contralateral quadrant of the same patients, stainless steel crowns placed on mandibular second primary molars (tooth 85) were cemented using a high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan). Clinical periodontal parameters and gingival crevicular fluid cytokine levels (IL-10, IL-12, IL-18) were assessed before treatment and one week after cementation for comparison with the resin cement group.
Interventions
Stainless steel crowns were placed on mandibular second primary molars in systemically healthy children aged 6-10 years using a split-mouth design. After standard tooth preparation and crown adaptation, cementation was performed using two different luting materials. In one quadrant, crowns were cemented with a self-adhesive resin cement (G-Cem ONE™, GC, Japan), which provides chemical adhesion without the need for separate etching or bonding procedures. In the contralateral quadrant, crowns were cemented with a high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan), characterized by fluoride release and conventional acid-base bonding properties. Clinical periodontal parameters (plaque index, gingival index, bleeding on probing) and gingival crevicular fluid cytokine levels (IL-10, IL-12, IL-18) were evaluated before treatment and one week after cementation to assess early biological and clinical periodontal responses to the different cementation material
A high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan) was used for cementation of stainless steel crowns according to standard clinical procedures.
Eligibility Criteria
You may qualify if:
- Children aged 6-10 years
- Systemically healthy pediatric patients
- Presence of bilateral mandibular second primary molars (teeth 75 and 85) requiring stainless steel crown restoration
- Absence of clinical signs of active periodontal disease
- Cooperative behavior sufficient to allow dental treatment and gingival crevicular fluid sampling
- Written informed consent obtained from parents or legal guardians
You may not qualify if:
- Presence of systemic diseases or medical conditions affecting periodontal health or immune response
- Use of antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the last month
- Poor oral hygiene or untreated periodontal disease
- Teeth with pulpal pathology, mobility, or advanced root resorption
- History of allergy to dental materials used in the study
- Lack of parental consent or inability to complete follow-up examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Afyonkarahisar Health Science University
Afyonkarahisar, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- non
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Prof.
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 19, 2026
Study Start
February 16, 2026
Primary Completion
March 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared due to ethical and privacy considerations, particularly because the study involves pediatric participants. All reported results will be presented in aggregated and anonymized form to ensure participant confidentiality.