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Clinical Trials in Turkey / NCT07421206
Starting soon Not applicable

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

NCT07421206 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-02-16
Last updated
2026-02-19

Condition(s) studied

Dental CariesGingival InflammationPeriodontal Response to Dental Restorative Materials

Investigational drug(s) / intervention(s)

Self-Adhesive Resin Cement GroupHigh-Viscosity Glass Ionomer Cement

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
10 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Afyonkarahisar Health Science University Afyonkarahisar Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07421206 on ClinicalTrials.gov ↗ ← All trials in Turkey