Dental CariesSSC-CYTONCT07421206
DETERMINATION OF THE EFFECTS OF STAINLESS STEEL CROWNS CEMENTED WITH RESIN CEMENTS ON INTERLEUKIN-10, 12, 18 LEVELS IN GINGIVAL CREVICULAR FLUID
A study testing Self-Adhesive Resin Cement Group and High-Viscosity Glass Ionomer Cement in people with Dental Caries and Gingival Inflammation, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Gingival Inflammation, Periodontal Response to Dental Restorative Materials
- What is being tested?
- Self-Adhesive Resin Cement Group and High-Viscosity Glass Ionomer Cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar
MURAT YEŞİL, Associate Professor, +90 505 442 31 42, drmurat17@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- Dental Caries, Gingival Inflammation, Periodontal Response to Dental Restorative Materials
- Being tested
- Self-Adhesive Resin Cement Group, High-Viscosity Glass Ionomer Cement
- Keywords
- Stabnless steel crown, gingival crevicular fluid, interleukin-10, interleukin-12, interleukin-18, resin cement
- Medical subject headings
- Dental Caries, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Adhesive Resin Cement GroupOther
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 CementDevice
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 group | Role | What they receive |
|---|---|---|
| Self-Adhesive Resin Cement Group | Experimental | In this split-mouth clinical study, stainless steel crowns placed on mandibular second primary molars (tooth 75) were cemented using a self-adhesive resin cement (G-Cem ONE™, GC, Japan). Clinical periodontal parameters (plaque index, gingival index, and bleeding on probing) and gingival crevicular fluid levels of interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) were evaluated before treatment and one week after cementation. Receives: Device: High-Viscosity Glass Ionomer Cement |
| High-Viscosity Glass Ionomer Cement Group | Active comparator | In the contralateral quadrant of the same patients, stainless steel crowns placed on mandibular second primary molars (tooth 85) were cemented using a high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan). Clinical periodontal parameters and gingival crevicular fluid cytokine levels (IL-10, IL-12, IL-18) were assessed before treatment and one week after cementation for comparison with the resin cement group. Receives: Other: Self-Adhesive Resin Cement Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week post-cementation
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.
Measured: Baseline and 1 week post-cementation
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.
Measured: Baseline and 1 week after cementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start16 Feb 2026 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Doğan, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421206
- Sponsor's protocol ID
- 2025HATICE
- Other IDs
- AFSU SCIENTIFIC RESEARCH COORD
- Acronym
- SSC-CYTO
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations, particularly because the study involves pediatric participants. All reported results will be presented in aggregated and anonymized form to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07421206
- Acronym / sponsor ID
- SSC-CYTO / 2025HATICE
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-Adhesive Resin Cement Group | Experimental | Device: High-Viscosity Glass Ionomer CementIn this split-mouth clinical study, stainless steel crowns placed on mandibular second primary molars (tooth 75) were cemented using a self-adhesive resin cement (G-Cem ONE™, GC, Japan). Clinical periodontal parameters (plaque index, gingival index, and bleeding on probing) and gingival crevicular fluid levels of interleukin-10 (IL-10), interleukin-12 (IL-12), and interleukin-18 (IL-18) were evaluated before treatment and one week after cementation. |
| High-Viscosity Glass Ionomer Cement Group | Active comparator | Other: Self-Adhesive Resin Cement GroupIn the contralateral quadrant of the same patients, stainless steel crowns placed on mandibular second primary molars (tooth 85) were cemented using a high-viscosity glass ionomer restorative material (EQUIA Forte™ HT, GC, Tokyo, Japan). Clinical periodontal parameters and gingival crevicular fluid cytokine levels (IL-10, IL-12, IL-18) were assessed before treatment and one week after cementation for comparison with the resin cement group. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Adhesive Resin Cement GroupStainless 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 | Other | High-Viscosity Glass Ionomer Cement Group |
| High-Viscosity Glass Ionomer CementA 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. | Device | Self-Adhesive Resin Cement Group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations, particularly because the study involves pediatric participants. All reported results will be presented in aggregated and anonymized form to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Adhesive Resin Cement Group and High-Viscosity Glass Ionomer Cement in people with Dental Caries and Gingival Inflammation, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OZGUR DOGAN, Associate Professor (905548714080, ozgurdogan1984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-18 (time frame: Baseline and 1 week post-cementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.