Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07421206
Acronym
SSC-CYTO
Enrollment
45
Registered
2026-02-19
Start date
2026-02-16
Completion date
2026-05-30
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Gingival Inflammation, Periodontal Response to Dental Restorative Materials

Keywords

Stabnless steel crown, gingival crevicular fluid, interleukin-10, interleukin-12, interleukin-18, resin cement

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.

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.

Interventions

OTHERSelf-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

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.

Sponsors

Afyonkarahisar Health Sciences University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

non

Intervention model description

This study used a split-mouth design in which each participant received two stainless steel crowns on bilateral mandibular second primary molars. One tooth was cemented with a self-adhesive resin cement, while the contralateral tooth was cemented with a high-viscosity glass ionomer cement. This design allowed intra-individual comparison of periodontal clinical parameters and gingival crevicular fluid cytokine levels while minimizing inter-individual variability.

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
IL-18Baseline and 1 week post-cementationIL-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.
Change in gingival crevicular fluid interleukin-12 (IL-12)levelsBaseline and 1 week post-cementationIL-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.
Change in gingival crevicular fluid interleukin-10 (IL-10) levelsBaseline and 1 week after cementationIL-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.

Countries

Turkey (Türkiye)

Contacts

CONTACTOZGUR DOGAN, Associate Professor
ozgurdogan1984@gmail.com905548714080
CONTACTHATICE HATIPOGLU, RESEARCHER
haticehhatipoglu@gmail.com+90 534 857 60 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026