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Completed

NCT Number: NCT07611292

Periodontal Biocompatibility of Pediatric Crowns

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.

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Key information

Conditions

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

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sema Aydinoglu

Rize, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical periodontal assessments, GCF measurements and sample collection

Other

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).

Primary outcomes

  1. assessment of probing pocket depth (PPD)

    Time frame: 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.

  2. assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)

    Time frame: 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).

  3. Assessment of bleeding on probing (BOP)

    Time frame: 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.

  4. Assessment of plaque index (PI)

    Time frame: 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.

  5. Assessment of Gingival index (GI)

    Time frame: 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.

  6. Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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