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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorAfyonkarahisar Health Sciences University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self-Adhesive Resin Cement Group

    Other intervention

    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

    Device

    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.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Self-Adhesive Resin Cement GroupExperimental treatment 1 intervention
Group B: High-Viscosity Glass Ionomer Cement GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 1 week post-cementation
2

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.

Time frame
Baseline and 1 week post-cementation
3

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.

Time frame
Baseline and 1 week after cementation

Secondary outcomes

Other outcomes

Sponsors and contacts

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