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NCT07421206
NA

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

Sponsor: Afyonkarahisar Health Sciences University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-02-16

Completion Date

2026-05-30

Last Updated

2026-02-19

Healthy Volunteers

Yes

Interventions

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

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.

Locations (1)

Afyonkarahisar Health Science University

Afyonkarahisar, Turkey (Türkiye)