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Periodontal Biocompatibility of Pediatric Crowns

Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07611292
Enrollment
21
Registered
2026-05-28
Start date
2024-06-30
Completion date
2026-04-20
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Matrix Metalloproteinase, Oral Health, Pediatric Dentistry, Periodontal Health, Stainless-steel Crown

Keywords

oral health, pediatric dentistry, periodontal health

Brief summary

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.

Interventions

OTHERClinical 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).

Sponsors

Recep Tayyip Erdogan University Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* Children who were aged between 6 and 9 years * Children had a score of 3 or 4 on the Frankl Behavioral Scale * Children had an indication for full coronal restoration in the primary second molars in all the three quadrants * Presence of extensive or chronic carious lesions involving the pulp with radiographic scores ranging between 2 and 3 * Presence of localized hypoplastic defects * Normal or non-resorbed interproximal bone levels, defined radiographically as a distance of no more than 2 mm between the interdental bone crest and the cementoenamel junction * Those where the root resorption level was blunt or the apex was rounded, and those where 1/4 of the root has been resorbed

Exclusion criteria

* Children had any systemic disease * History of allergy to local anesthetic agents, nickel, or resin-based restorative materials * Extremely poor oral hygiene * Periodontal disease * Malocclusion

Design outcomes

Primary

MeasureTime frameDescription
assessment of probing pocket depth (PPD)From beginning to the end of treatment at 6 monthsprobing 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.
assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)in the sixth month (after sample collection was complete)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).
Assessment of bleeding on probing (BOP)From beginning to the end of treatment at 6 monthsBleeding 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.
Assessment of plaque index (PI)From beginning to the end of treatment at 6 monthsPlaque 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.
Assessment of Gingival index (GI)From beginning to the end of treatment at 6 monthsGingival 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.
Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)in the sixth month (after sample collection was complete)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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 3, 2026