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Periodontal Biocompatibility of Pediatric Crowns

20 mei 2026 bijgewerkt door: Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Werkelijk)

21

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

children who applied for the dental treatment to the Faculty of Dentistry in Rize

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Group 1
Teeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown.
Ander: 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).
Group 2
Teeth diagnosed with an indication for full coronal restoration and treated with prefabricated zirconia crown.
Ander: 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).
Group 3
Teeth diagnosed with an indication for full coronal restoration and treated with fiber glass crown.
Ander: 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).
Group 4
Healthy primary molars (control group)
Ander: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juni 2024

Primaire voltooiing (Werkelijk)

30 december 2025

Studie voltooiing (Werkelijk)

20 april 2026

Studieregistratiedata

Eerst ingediend

14 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

20 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2024/05 (Andere identificatie: Atatürk University Clinical Research Ethics Committee)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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