Periodontal Biocompatibility of Pediatric Crowns

NCT07611292 | Completed

• 1 other identifier: 2024/05
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

oral health; pediatric dentistry; periodontal health

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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.

  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.

  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.

  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).

  in the sixth month (after sample collection was complete)

Study Arms (4)

Group 1

Teeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown.

Other: Clinical periodontal assessments, GCF measurements and sample collection

Group 2

Teeth diagnosed with an indication for full coronal restoration and treated with prefabricated zirconia crown.

Other: Clinical periodontal assessments, GCF measurements and sample collection

Group 3

Teeth diagnosed with an indication for full coronal restoration and treated with fiber glass crown.

Other: Clinical periodontal assessments, GCF measurements and sample collection

Group 4

Healthy primary molars (control group)

Other: Clinical periodontal assessments, GCF measurements and sample collection

Interventions

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).

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Sema Aydinoglu

Rize, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

gingival crevicular fluid of participants was retained.

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: June 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: April 20, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

TU (1)