Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07421206

DETERMINATION OF THE EFFECTS OF STAINLESS STEEL CROWNS CEMENTED WITH RESIN CEMENTS ON INTERLEUKIN-10, 12, 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dental Caries Gingival Diseases Gingival Inflammation Gingivitis Infections Mouth Diseases Periodontal Diseases Periodontal Response to Dental Restorative Materials Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Adhesive Resin Cement Group

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

HATICE HATIPOGLU, RESEARCHER

CONTACT

[email protected]

+90 534 857 60 20

OZGUR DOGAN, Associate Professor

CONTACT

[email protected]

905548714080

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study 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

Acronym: SSC-CYTO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.