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Periodontal Biocompatibility of Pediatric Crowns

20. května 2026 aktualizováno: 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.

Přehled studie

Typ studie

Pozorovací

Zápis (Aktuální)

21

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Group 1
Teeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown.

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.

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.

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)

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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
assessment of probing pocket depth (PPD)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. června 2024

Primární dokončení (Aktuální)

30. prosince 2025

Dokončení studie (Aktuální)

20. dubna 2026

Termíny zápisu do studia

První předloženo

14. května 2026

První předloženo, které splnilo kritéria kontroly kvality

20. května 2026

První zveřejněno (Aktuální)

28. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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