An observational study in Oral Health, Pediatric Dentistry and Stainless-steel Crown, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational
Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface characteristics, marginal adaptation, and biological properties. The aim of this study was to evaluate the effects of stainless steel crowns (SSC), prefabricated zirconia crowns (PZC), and fiber-glass crowns (FGC) on periodontal health in children using both clinical periodontal parameters and gingival crevicular fluid (GCF) biomarkers, including IL-1β and MMP-8, within a split-mouth study design.
Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.
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children who applied for the dental treatment to the Faculty of Dentistry in Rize
Exclusion Criteria:
Teeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown.
Other: Clinical periodontal assessments, GCF measurements and sample collection
Teeth diagnosed with an indication for full coronal restoration and treated with prefabricated zirconia crown.
Other: Clinical periodontal assessments, GCF measurements and sample collection
Teeth diagnosed with an indication for full coronal restoration and treated with fiber glass crown.
Other: Clinical periodontal assessments, GCF measurements and sample collection
Healthy primary molars (control group)
Other: Clinical periodontal assessments, GCF measurements and sample collection
Clinical periodontal assessments were carried out for all participants at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) follow-up visits. The clinical periodontal status was assessed with the probing pocket depth (PPD), bleeding on probing (BOP), plaque index (PI), and gingival index (GI). For each patient, GCF measurements and sample collection were performed at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) visits. MMP-8 and IL-1β analyses were performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA).
assessment of probing pocket depth (PPD)
probing pocket depth (PPD) was measured the distance between the gingival margin and the deepest point of the sulcus. PPD was evaluated from six surfaces (mesiobuccal, midbuccal, distobuccal, mesiolingual/mesiopalatal, midlingual/midpalatal, and distolingual/distopalatal) of the teeth. The measurements were done utilizing a Williams periodontal probe.
Time frame: From beginning to the end of treatment at 6 months
assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)
MMP-8 was performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA) in the Medical Biochemistry Research and Application Laboratory of the Recep Tayyip Erdogan University Faculty of Medicine. Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C. Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C). Each GCF specimen was analyzed individually without combining the samples. The results were expressed in ng/mL (MMP-8).
Time frame: in the sixth month (after sample collection was complete)
Assessment of bleeding on probing (BOP)
Bleeding on probing (BOP) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Time frame: From beginning to the end of treatment at 6 months
Assessment of plaque index (PI)
Plaque index (PI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Time frame: From beginning to the end of treatment at 6 months
Assessment of Gingival index (GI)
Gingival index (GI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Time frame: From beginning to the end of treatment at 6 months
Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)
In GCF samples taken from patients, IL-1β level was determined by enzyme-linked immunosorbent assay (ELISA) according to the manufacturer's instructions at the Medical Biochemistry Research and Application Laboratory of Recep Tayyip Erdoğan University Faculty of Medicine. Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C. Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C). Each GCF specimen was analyzed individually without combining the samples. The results were expressed in pg/mL (IL-1β).
Time frame: in the sixth month (after sample collection was complete)
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Recep Tayyip Erdogan University Training and Research Hospital