DETERMINATION OF THE EFFECTS OF STAINLESS STEEL CROWNS CEMENTED WITH RESIN CEMENTS ON INTERLEUKIN-10, 12, 18 LEVELS IN GINGIVAL CREVICULAR FLUID (SSC-CYTO)

February 12, 2026 updated by: Özgür Doğan, Afyonkarahisar Health Sciences University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stainless steel crowns (SSCs) are widely used in pediatric dentistry for the restoration of severely decayed primary molars due to their durability, cost-effectiveness, and full coronal coverage. Despite their extensive clinical use, concerns remain regarding their potential effects on periodontal tissues, particularly in relation to gingival inflammation and biological responses associated with different luting cements. Resin-based cements and glass ionomer-based materials are commonly used for cementation of SSCs; however, their comparative effects on gingival inflammatory biomarkers have not been fully clarified.

This split-mouth clinical study was designed to evaluate the early periodontal and biological effects of stainless steel crowns cemented with two different materials: a self-adhesive resin cement and a high-viscosity glass ionomer restorative cement. The study included systemically healthy pediatric patients aged 6-10 years requiring stainless steel crown restoration of bilateral mandibular second primary molars. Each participant received two crowns under standardized clinical conditions, allowing intra-individual comparison of the two cementation materials.

Clinical periodontal parameters, including plaque index, gingival index, and bleeding on probing, were recorded before treatment and one week after crown cementation. In addition, gingival crevicular fluid samples were collected at the same time points to evaluate inflammatory cytokine levels. Interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) were selected as biomarkers because of their roles in inflammatory regulation and immune response in periodontal tissues. Cytokine levels were analyzed using enzyme-linked immunosorbent assay (ELISA) techniques.

The primary objective of the study was to assess whether the type of cement used for stainless steel crowns influences gingival inflammatory response during the early postoperative period. Secondary objectives included evaluation of short-term clinical periodontal outcomes associated with these restorative procedures.

Understanding the biological effects of various cementation materials may help optimize restorative strategies in pediatric dentistry, improve periodontal tissue compatibility, and inform evidence-based selection of luting materials for stainless steel crowns. The findings of this study may provide clinically relevant information regarding both periodontal health and biomarker responses following stainless steel crown placement in children.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Afyonkarahisar, Turkey (Türkiye)
        • Afyonkarahisar Health Science University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Adhesive Resin Cement Group
In 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.
Device: High-Viscosity Glass Ionomer Cement
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.
Active Comparator: High-Viscosity Glass Ionomer Cement Group
In 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.
Other: Self-Adhesive Resin Cement Group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-18
Time Frame: Baseline and 1 week post-cementation
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
Time Frame: Baseline and 1 week post-cementation
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
Time Frame: Baseline and 1 week after cementation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afyonkarahisar Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 16, 2026

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025HATICE
  • AFSU SCIENTIFIC RESEARCH COORD (Other Grant/Funding Number: 24.DUS.004)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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